Yvonne Maldonado

All Publications

• Hepatitis B virus clinical and virologic characteristics in an HIV perinatal transmission study in sub-saharan Africa, HPTN 046- a post-hoc analysis. AIDS (London, England) Bhattacharya, D., Guo, R., Tseng, C. H., Emel, L., Sun, R., Zhang, T. H., Chiu, S. H., Stranix-Chibanda, L., Chipato, T., Ship, H., Mohtashemi, N. Z., Kintu, K., Manji, K. P., Moodley, D., Maldonado, Y., Currier, J. S., Thio, C. L. 2023

  Abstract

  To describe the clinical and virologic characteristics of HIV-HBV coinfection, including the predictors of high maternal HBV viral load in pregnant women with HIV in sub-Saharan Africa (SSA).HPTN 046 was a HIV perinatal transmission clinical trial evaluating infant nevirapine vs placebo. Women-infant pairs (n = 2016) were enrolled in SSA from 2007-2010; 1579 (78%) received antiretrovirals (ARV). Maternal delivery samples were retrospectively tested for hepatitis B surface antigen (HBsAg), and if positive, were tested for hepatitis B e antigen (HBeAg) and HBV viral load (VL). High HBV VL was defined as ≥106 IU/ml.Overall, 4.4% (88/2016) had HBV co-infection, with geographic variability ranging from 2.4-8.7% (p < 0.0001); 25% (22/88) were HBeAg positive with prevalence in countries ranging from 10.5-39%. Fifty-two percent (40/77) of those with HBV received ARV, the majority (97%) received 3TC as the only HBV active agent.. HBeAg positivity was associated with high maternal HBV VL, OR 37.0, 95% CI 5.4-252.4. Of those with high HBV VL, 40% (4/10) were receiving HBV active drugs (HBV-ARV).. HBV drug resistance occurred in 7.5% (3/40) receiving HBV- ARV.In SSA, HBV co-infection is common in pregnant women with HIV. HBsAg and HBeAg prevalence vary widely by country in this clinical trial cohort. HBeAg is a surrogate for high HBV viral load. HBV drug resistance occurred in 7.5% receiving HBV-ARV with lamivudine as the only HBV active agent.. These findings reinforce the importance of HBsAg screening and early treatment with with two active agents for HBV.

  View details for DOI 10.1097/QAD.0000000000003752

  View details for PubMedID 37861675

• Rapid emergence and transmission of virulence-associated mutations in the oral poliovirus vaccine following vaccination campaigns. NPJ vaccines Walter, K. S., Altamirano, J., Huang, C., Carrington, Y. J., Zhou, F., Andrews, J. R., Maldonado, Y. 2023; 8 (1): 137

  Abstract

  There is an increasing burden of circulating vaccine-derived polioviruses (cVDPVs) due to the continued use of oral poliovirus vaccine (OPV). However, the informativeness of routine OPV VP1 sequencing for the early identification of viruses carrying virulence-associated reversion mutations has not been directly evaluated in a controlled setting. We prospectively collected 15,331 stool samples to track OPV shedding from children receiving OPV and their contacts for ten weeks following an immunization campaign in Veracruz State, Mexico and sequenced VP1 genes from 358 samples. We found that OPV was genetically unstable and evolves at an approximately clocklike rate that varies across serotypes and by vaccination status. Overall, 61% (11/18) of OPV-1, 71% (34/48) OPV-2, and 96% (54/56) OPV-3 samples with available data had evidence of a reversion at the key 5' UTR attenuating position and 28% (13/47) of OPV-1, 12% (14/117) OPV-2, and 91% (157/173) OPV-3 of Sabin-like viruses had ≥1 known reversion mutations in the VP1 gene. Our results are consistent with previous work documenting rapid reversion to virulence of OPV and underscores the need for intensive surveillance following OPV use.

  View details for DOI 10.1038/s41541-023-00740-9

  View details for PubMedID 37749086

  View details for PubMedCentralID 9712124

• Association of protective behaviors with SARS-CoV-2 infection: Results from a longitudinal cohort study of adults in the San Francisco Bay Area. Annals of epidemiology Judson, T. J., Zhang, S., Lindan, C. P., Boothroyd, D., Grumbach, K., Bollyky, J., Sample, H., Huang, B., Desai, M., Gonzales, R., Maldonado, Y., Rutherford, G. 2023

  Abstract

  In an effort to decrease transmission during the first years of the COVID-19 pandemic, public health officials encouraged masking, social distancing, and working from home, and restricted travel. However, many studies of the effectiveness of these measures had significant methodologic limitations. In this analysis, we used data from the TrackCOVID study, a longitudinal cohort study of a population-based sample of 3,846 adults in the San Francisco Bay Area, to evaluate the association between self-reported protective behaviors including masking, physical distancing, travel and working outside the home, and incidence of SARS-CoV-2 infection. Participants without SARS-CoV2 infection were enrolled from August-December 2020 and followed monthly with testing and surveys (median of 4 visits). A total of 118 incident infections occurred (3.0% of participants). At baseline, 80.0% reported always wearing a mask; 56.0% avoided contact with non-household members some/most of the time; 9.6% traveled outside the state; and 16.0% worked 20 or more hours per week outside the home. These behaviors did not change markedly over time. Factors associated with incident infection included being Black or Latinx, having less than a college education, and having more household residents. The only behavioral factor associated with incident infection was working outside the home (aHR 1.62, 95% CI 1.02-2.59). Focusing on protecting people who cannot work from home could help prevent infections during future waves of COVID-19, or future pandemics from respiratory viruses. This focus must be balanced with the known importance of directing resources toward those at risk of severe infections.

  View details for DOI 10.1016/j.annepidem.2023.07.009

  View details for PubMedID 37524216

• Electronic Nose Development and Preliminary Human Breath Testing for Rapid, Non-Invasive COVID-19 Detection. ACS sensors Li, J., Hannon, A., Yu, G., Idziak, L. A., Sahasrabhojanee, A., Govindarajan, P., Maldonado, Y. A., Ngo, K., Abdou, J. P., Mai, N., Ricco, A. J. 2023

  Abstract

  We adapted an existing, spaceflight-proven, robust "electronic nose" (E-Nose) that uses an array of electrical resistivity-based nanosensors mimicking aspects of mammalian olfaction to conduct on-site, rapid screening for COVID-19 infection by measuring the pattern of sensor responses to volatile organic compounds (VOCs) in exhaled human breath. We built and tested multiple copies of a hand-held prototype E-Nose sensor system, composed of 64 chemically sensitive nanomaterial sensing elements tailored to COVID-19 VOC detection; data acquisition electronics; a smart tablet with software (App) for sensor control, data acquisition and display; and a sampling fixture to capture exhaled breath samples and deliver them to the sensor array inside the E-Nose. The sensing elements detect the combination of VOCs typical in breath at parts-per-billion (ppb) levels, with repeatability of 0.02% and reproducibility of 1.2%; the measurement electronics in the E-Nose provide measurement accuracy and signal-to-noise ratios comparable to benchtop instrumentation. Preliminary clinical testing at Stanford Medicine with 63 participants, their COVID-19-positive or COVID-19-negative status determined by concomitant RT-PCR, discriminated between these two categories of human breath with a 79% correct identification rate using "leave-one-out" training-and-analysis methods. Analyzing the E-Nose response in conjunction with body temperature and other non-invasive symptom screening using advanced machine learning methods, with a much larger database of responses from a wider swath of the population, is expected to provide more accurate on-the-spot answers. Additional clinical testing, design refinement, and a mass manufacturing approach are the main steps toward deploying this technology to rapidly screen for active infection in clinics and hospitals, public and commercial venues, or at home.

  View details for DOI 10.1021/acssensors.3c00367

  View details for PubMedID 37224474

• Rapid emergence and transmission of virulence-associated mutations in the oral poliovirus vaccine following vaccination campaigns. medRxiv : the preprint server for health sciences Walter, K. S., Altamirano, J., Huang, C., Carrington, Y. J., Zhou, F., Andrews, J. R., Maldonado, Y. 2023

  Abstract

  There is an increasing burden of circulating vaccine-derived polioviruses (cVDPVs) due to the continued use of oral poliovirus vaccine (OPV). However, the informativeness of routine OPV VP1 sequencing for the early identification of viruses carrying virulence-associated reversion mutations has not been directly evaluated in a controlled setting. We prospectively collected 15,331 stool samples to track OPV shedding from vaccinated children and their contacts for ten weeks following an immunization campaign in Veracruz State, Mexico and sequenced VP1 genes from 358 samples. We found that OPV was genetically unstable and evolves at an approximately clocklike rate that varies across serotypes and by vaccination status. Alarmingly, 28% (13/47) of OPV-1, 12% (14/117) OPV-2, and 91% (157/173) OPV-3 of Sabin-like viruses had ≥1 known reversion mutation. Our results suggest that current definitions of cVDPVs may exclude circulating virulent viruses that pose a public health risk and underscore the need for intensive surveillance following OPV use.

  View details for DOI 10.1101/2023.03.16.23287381

  View details for PubMedID 36993386

  View details for PubMedCentralID PMC10055580

• Confronting the evolution and expansion of anti-vaccine activism in the USA in the COVID-19 era. Lancet (London, England) Carpiano, R. M., Callaghan, T., DiResta, R., Brewer, N. T., Clinton, C., Galvani, A. P., Lakshmanan, R., Parmet, W. E., Omer, S. B., Buttenheim, A. M., Benjamin, R. M., Caplan, A., Elharake, J. A., Flowers, L. C., Maldonado, Y. A., Mello, M. M., Opel, D. J., Salmon, D. A., Schwartz, J. L., Sharfstein, J. M., Hotez, P. J. 2023

  View details for DOI 10.1016/S0140-6736(23)00136-8

  View details for PubMedID 36871571

• Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age. The New England journal of medicine Muñoz, F. M., Sher, L. D., Sabharwal, C., Gurtman, A., Xu, X., Kitchin, N., Lockhart, S., Riesenberg, R., Sexter, J. M., Czajka, H., Paulsen, G. C., Maldonado, Y., Walter, E. B., Talaat, K. R., Englund, J. A., Sarwar, U. N., Hansen, C., Iwamoto, M., Webber, C., Cunliffe, L., Ukkonen, B., Martínez, S. N., Pahud, B. A., Munjal, I., Domachowske, J. B., Swanson, K. A., Ma, H., Koury, K., Mather, S., Lu, C., Zou, J., Xie, X., Shi, P. Y., Cooper, D., Türeci, Ö., Şahin, U., Jansen, K. U., Gruber, W. C. 2023; 388 (7): 621-634

  Abstract

  Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children.We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2-3 trial, participants were randomly assigned (in a 2:1 ratio) to receive two 3-μg doses of BNT162b2 or placebo. On the basis of preliminary immunogenicity results, a third 3-μg dose (≥8 weeks after dose 2) was administered starting in January 2022, which coincided with the emergence of the B.1.1.529 (omicron) variant. Immune responses at 1 month after doses 2 and 3 in children 6 months to less than 2 years of age and those 2 to 4 years of age were immunologically bridged to responses after dose 2 in persons 16 to 25 years of age who received 30 μg of BNT162b2 in the pivotal trial.During the phase 1 dose-finding study, two doses of BNT162b2 were administered 21 days apart to 16 children 6 months to less than 2 years of age (3-μg dose) and 48 children 2 to 4 years of age (3-μg or 10-μg dose). The 3-μg dose level was selected for the phase 2-3 trial; 1178 children 6 months to less than 2 years of age and 1835 children 2 to 4 years of age received BNT162b2, and 598 and 915, respectively, received placebo. Immunobridging success criteria for the geometric mean ratio and seroresponse at 1 month after dose 3 were met in both age groups. BNT162b2 reactogenicity events were mostly mild to moderate, with no grade 4 events. Low, similar incidences of fever were reported after receipt of BNT162b2 (7% among children 6 months to <2 years of age and 5% among those 2 to 4 years of age) and placebo (6 to 7% among children 6 months to <2 years of age and 4 to 5% among those 2 to 4 years of age). The observed overall vaccine efficacy against symptomatic Covid-19 in children 6 months to 4 years of age was 73.2% (95% confidence interval, 43.8 to 87.6) from 7 days after dose 3 (on the basis of 34 cases).A three-dose primary series of 3-μg BNT162b2 was safe, immunogenic, and efficacious in children 6 months to 4 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

  View details for DOI 10.1056/NEJMoa2211031

  View details for PubMedID 36791162

• Challenges in Harnessing Shared Within-Host Severe Acute Respiratory Syndrome Coronavirus 2 Variation for Transmission Inference. Open forum infectious diseases Walter, K. S., Kim, E., Verma, R., Altamirano, J., Leary, S., Carrington, Y. J., Jagannathan, P., Singh, U., Holubar, M., Subramanian, A., Khosla, C., Maldonado, Y., Andrews, J. R. 2023; 10 (2): ofad001

  Abstract

  The limited variation observed among severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) consensus sequences makes it difficult to reconstruct transmission linkages in outbreak settings. Previous studies have recovered variation within individual SARS-CoV-2 infections but have not yet measured the informativeness of within-host variation for transmission inference.We performed tiled amplicon sequencing on 307 SARS-CoV-2 samples, including 130 samples from 32 individuals in 14 households and 47 longitudinally sampled individuals, from 4 prospective studies with household membership data, a proxy for transmission linkage.Consensus sequences from households had limited diversity (mean pairwise distance, 3.06 single-nucleotide polymorphisms [SNPs]; range, 0-40). Most (83.1%, 255 of 307) samples harbored at least 1 intrahost single-nucleotide variant ([iSNV] median, 117; interquartile range [IQR], 17-208), above a minor allele frequency threshold of 0.2%. Pairs in the same household shared significantly more iSNVs (mean, 1.20 iSNVs; 95% confidence interval [CI], 1.02-1.39) than did pairs in different households infected with the same viral clade (mean, 0.31 iSNVs; 95% CI, .28-.34), a signal that decreases with increasingly stringent minor allele frequency thresholds. The number of shared iSNVs was significantly associated with an increased odds of household membership (adjusted odds ratio, 1.35; 95% CI, 1.23-1.49). However, the poor concordance of iSNVs detected across sequencing replicates (24.8% and 35.0% above a 0.2% and 1% threshold) confirms technical concerns that current sequencing and bioinformatic workflows do not consistently recover low-frequency within-host variants.Shared within-host variation may augment the information in consensus sequences for predicting transmission linkages. Improving sensitivity and specificity of within-host variant identification will improve the informativeness of within-host variation.

  View details for DOI 10.1093/ofid/ofad001

  View details for PubMedID 36751652

  View details for PubMedCentralID PMC9898879

• Lessons From a House on Fire-From Smallpox to Polio JOURNAL OF INFECTIOUS DISEASES Maldonado, Y. A. 2023

  View details for DOI 10.1093/infdis/jiad017

  View details for Web of Science ID 000938260500001

  View details for PubMedID 36691964

• Strategies to Increase Workforce Diversity in Pediatric Infectious Diseases. Journal of the Pediatric Infectious Diseases Society Rogo, T., Holland, S., Fassiotto, M., Maldonado, Y., Joseph, T., Ramilo, O., Byrd, K., Delair, S. 2022; 11 (Supplement_4): S148-S154

  Abstract

  The number of physicians who are underrepresented in medicine within the pediatric infectious diseases workforce remains disproportionate compared to the US population. Physician workforce diversity plays an important role in reducing health care disparities. Pathways to careers in pediatric infectious diseases require that a diverse pool of students enter medicine and subsequently choose pediatric residency followed by subspecialty training. Efforts must be made to expose learners to pediatric infectious diseases earlier in the education timeline. Along with recruitment and creation of pathways, cultures of inclusivity must be created and fostered within institutions of learning along the entire spectrum of medical training.

  View details for DOI 10.1093/jpids/piac094

  View details for PubMedID 36477593

• Disability Identity Among Diverse Learners and Employees at an Academic Medical Center. JAMA network open Jerome, B., Fassiotto, M., Altamirano, J., Sutha, K., Maldonado, Y., Poullos, P. 2022; 5 (11): e2241948

  Abstract

  This survey study evaluates representation of persons with disabilities across demographic characteristics at an academic medical center.

  View details for DOI 10.1001/jamanetworkopen.2022.41948

  View details for PubMedID 36355375

• The legacy of the COVID-19 pandemic for childhood vaccination in the USA. Lancet (London, England) Opel, D. J., Brewer, N. T., Buttenheim, A. M., Callaghan, T., Carpiano, R. M., Clinton, C., Elharake, J. A., Flowers, L. C., Galvani, A. P., Hotez, P. J., Schwartz, J. L., Benjamin, R. M., Caplan, A., DiResta, R., Lakshmanan, R., Maldonado, Y. A., Mello, M. M., Parmet, W. E., Salmon, D. A., Sharfstein, J. M., Omer, S. B. 2022

  View details for DOI 10.1016/S0140-6736(22)01693-2

  View details for PubMedID 36309017

• Early immune markers of clinical, virological, and immunological outcomes in patients with COVID-19: a multi-omics study. eLife Hu, Z., van der Ploeg, K., Chakraborty, S., Arunachalam, P. S., Mori, D. A., Jacobson, K. B., Bonilla, H., Parsonnet, J., Andrews, J. R., Holubar, M., Subramanian, A., Khosla, C., Maldonado, Y., Hedlin, H., de la Parte, L., Press, K., Ty, M., Tan, G. S., Blish, C., Takahashi, S., Rodriguez-Barraquer, I., Greenhouse, B., Butte, A. J., Singh, U., Pulendran, B., Wang, T. T., Jagannathan, P. 2022; 11

  Abstract

  The great majority of severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infections are mild and uncomplicated, but some individuals with initially mild COVID-19 progressively develop more severe symptoms. Furthermore, there is substantial heterogeneity in SARS-CoV-2-specific memory immune responses following infection. There remains a critical need to identify host immune biomarkers predictive of clinical and immunological outcomes in SARS-CoV-2-infected patients.Leveraging longitudinal samples and data from a clinical trial (N=108) in SARS-CoV-2-infected outpatients, we used host proteomics and transcriptomics to characterize the trajectory of the immune response in COVID-19 patients. We characterized the association between early immune markers and subsequent disease progression, control of viral shedding, and SARS-CoV-2-specific T cell and antibody responses measured up to 7 months after enrollment. We further compared associations between early immune markers and subsequent T cell and antibody responses following natural infection with those following mRNA vaccination. We developed machine-learning models to predict patient outcomes and validated the predictive model using data from 54 individuals enrolled in an independent clinical trial.We identify early immune signatures, including plasma RIG-I levels, early IFN signaling, and related cytokines (CXCL10, MCP1, MCP-2, and MCP-3) associated with subsequent disease progression, control of viral shedding, and the SARS-CoV-2-specific T cell and antibody response measured up to 7 months after enrollment. We found that several biomarkers for immunological outcomes are shared between individuals receiving BNT162b2 (Pfizer-BioNTech) vaccine and COVID-19 patients. Finally, we demonstrate that machine-learning models using 2-7 plasma protein markers measured early within the course of infection are able to accurately predict disease progression, T cell memory, and the antibody response post-infection in a second, independent dataset.Early immune signatures following infection can accurately predict clinical and immunological outcomes in outpatients with COVID-19 using validated machine-learning models.Support for the study was provided from National Institute of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) (U01 AI150741-01S1 and T32-AI052073), the Stanford's Innovative Medicines Accelerator, National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA) DP1DA046089, and anonymous donors to Stanford University. Peginterferon lambda provided by Eiger BioPharmaceuticals.

  View details for DOI 10.7554/eLife.77943

  View details for PubMedID 36239699

• Building Programs to Eradicate Toxoplasmosis Part III: Epidemiology and Risk Factors. Current pediatrics reports Felín, M. S., Wang, K., Raggi, C., Moreira, A., Pandey, A., Grose, A., Caballero, Z., Rengifo-Herrera, C., Ramirez, M., Moossazadeh, D., Castro, C., Montalvo, J. L., Leahy, K., Zhou, Y., Clouser, F. A., Siddiqui, M., Leong, N., Goodall, P., Michalowski, M., Ismail, M., Christmas, M., Schrantz, S., Norero, X., Estripeaut, D., Ellis, D., Ashi, K., Dovgin, S., Dixon, A., Li, X., Begeman, I., Heichman, S., Lykins, J., Villalobos-Cerrud, D., Fabrega, L., Mendivil, C., Quijada, M. R., Fernández-Pirla, S., de La Guardia, V., Wong, D., de LadrónGuevara, M., Flores, C., Borace, J., García, A., Caballero, N., de Saez, M. T., Politis, M., Ross, S., Dogra, M., Dhamsania, V., Graves, N., Kirchberg, M., Mathur, K., Aue, A., Restrepo, C. M., Llanes, A., Guzman, G., Rebollon, A., Boyer, K., Heydemann, P., Noble, A. G., Swisher, C., Rabiah, P., Withers, S., Hull, T., Su, C., Blair, M., Latkany, P., Mui, E., Vasconcelos-Santos, D. V., Villareal, A., Perez, A., Galvis, C. A., Montes, M. V., Perez, N. I., Ramirez, M., Chittenden, C., Wang, E., Garcia-López, L. L., Muñoz-Ortiz, J., Rivera-Valdivia, N., Bohorquez-Granados, M. C., de-la-Torre, G. C., Padrieu, G., Hernandez, J. D., Celis-Giraldo, D., Acosta Dávila, J. A., Torres, E., Oquendo, M. M., Arteaga-Rivera, J. Y., Nicolae, D., Rzhetsky, A., Roizen, N., Stillwaggon, E., Sawers, L., Peyron, F., Wallon, M., Chapey, E., Levigne, P., Charter, C., De Frias, M., Montoya, J., Press, C., Ramirez, R., Contopoulos-Ioannidis, D., Maldonado, Y., Liesenfeld, O., Gomez, C., Wheeler, K., Holfels, E., Frim, D., McLone, D., Penn, R., Cohen, W., Zehar, S., McAuley, J., Limonne, D., Houze, S., Abraham, S., Piarroux, R., Tesic, V., Beavis, K., Abeleda, A., Sautter, M., El Mansouri, B., El Bachir, A., Amarir, F., El Bissati, K., de-la-Torre, A., Britton, G., Motta, J., Ortega-Barria, E., Romero, I. L., Meier, P., Grigg, M., Gómez-Marín, J., Kosagisharaf, J. R., Llorens, X. S., Reyes, O., McLeod, R. 2022; 10 (3): 109-124

  Abstract

  Review comprehensive data on rates of toxoplasmosis in Panama and Colombia.Samples and data sets from Panama and Colombia, that facilitated estimates regarding seroprevalence of antibodies to Toxoplasma and risk factors, were reviewed.Screening maps, seroprevalence maps, and risk factor mathematical models were devised based on these data. Studies in Ciudad de Panamá estimated seroprevalence at between 22 and 44%. Consistent relationships were found between higher prevalence rates and factors such as poverty and proximity to water sources. Prenatal screening rates for anti-Toxoplasma antibodies were variable, despite existence of a screening law. Heat maps showed a correlation between proximity to bodies of water and overall Toxoplasma seroprevalence. Spatial epidemiological maps and mathematical models identify specific regions that could most benefit from comprehensive, preventive healthcare campaigns related to congenital toxoplasmosis and Toxoplasma infection.

  View details for DOI 10.1007/s40124-022-00265-0

  View details for PubMedID 37744780

  View details for PubMedCentralID PMC10516319

• Gender Differences in National Institutes of Health Grant Submissions Before and During the COVID-19 Pandemic. Journal of women's health (2002) Roubinov, D., Haack, L. M., Folk, J. B., Rotenstein, L., Accurso, E. C., Dahiya, P., Ponce, A. N., Nava, V., Maldonado, Y., Linos, E., Mangurian, C. 2022; 31 (9): 1241-1245

  Abstract

  Introduction: Emerging data suggest that the COVID-19 pandemic has disproportionately impacted women in academic medicine, potentially eliminating recent gains that have been made toward gender equity. This study examined possible pandemic-related gender disparities in research grant submissions, one of the most important criteria for academic promotion and tenure evaluations. Methods: Data were collected from two major academic institutions (one private and one public) on the gender and academic rank of faculty principal investigators who submitted new grants to the National Institutes of Health (NIH) during COVID-19 (March 1st, 2020, through August 31, 2020) compared with a matched period in 2019 (March 1st, 2019, through August 31, 2019). t-Tests and chi-square analyses compared the gender distribution of individuals who submitted grants during the two periods of examination. Results: In 2019 (prepandemic), there was no significant difference in the average number of grants submitted by women compared with men faculty. In contrast, women faculty submitted significantly fewer grants in 2020 (during the pandemic) than men. Men were also significantly more likely than women to submit grants in both 2019 and 2020 compared with submitting in 2019 only, suggesting men faculty may have been more likely than their women colleagues to sustain their productivity in grant submissions during the pandemic. Discussion: Women's loss of extramural funding may compound over time, as it impedes new data collection, research progress, and academic advancement. Efforts to support women's research productivity and career trajectories are urgently needed in the following years of pandemic recovery.

  View details for DOI 10.1089/jwh.2022.0182

  View details for PubMedID 36112424

• Building Programs to Eradicate Toxoplasmosis Part II: Education. Current pediatrics reports Felín, M. S., Wang, K., Moreira, A., Grose, A., Leahy, K., Zhou, Y., Clouser, F. A., Siddiqui, M., Leong, N., Goodall, P., Michalowski, M., Ismail, M., Christmas, M., Schrantz, S., Caballero, Z., Norero, X., Estripeaut, D., Ellis, D., Raggi, C., Castro, C., Rengifo-Herrera, C., Moossazadeh, D., Ramirez, M., Pandey, A., Ashi, K., Dovgin, S., Dixon, A., Li, X., Begeman, I., Heichman, S., Lykins, J., Villalobos-Cerrud, D., Fabrega, L., Montalvo, J. L., Mendivil, C., Quijada, M. R., Fernández-Pirla, S., de La Guardia, V., Wong, D., de Guevara, M. L., Flores, C., Borace, J., García, A., Caballero, N., de Saez, M. T., Politis, M., Ross, S., Dogra, M., Dhamsania, V., Graves, N., Kirchberg, M., Mathur, K., Aue, A., Restrepo, C. M., Llanes, A., Guzman, G., Rebellon, A., Boyer, K., Heydemann, P., Noble, A. G., Swisher, C., Rabiah, P., Withers, S., Hull, T., Frim, D., McLone, D., Su, C., Blair, M., Latkany, P., Mui, E., Vasconcelos-Santos, D. V., Villareal, A., Perez, A., Galvis, C. A., Montes, M. V., Perez, N. I., Ramirez, M., Chittenden, C., Wang, E., Garcia-López, L. L., Muñoz-Ortiz, J., Rivera-Valdivia, N., Bohorquez-Granados, M. C., de-la-Torre, G. C., Padrieu, G., Hernandez, J. D., Celis-Giraldo, D., Dávila, J. A., Torres, E., Oquendo, M. M., Arteaga-Rivera, J. Y., Nicolae, D. L., Rzhetsky, A., Roizen, N., Stillwaggon, E., Sawers, L., Peyron, F., Wallon, M., Chapey, E., Levigne, P., Charter, C., De Frias, M., Montoya, J., Press, C., Ramirez, R., Contopoulos-Ioannidis, D., Maldonado, Y., Liesenfeld, O., Gomez, C., Wheeler, K., Zehar, S., McAuley, J., Limonne, D., Houze, S., Abraham, S., Piarroux, R., Tesic, V., Beavis, K., Abeleda, A., Sautter, M., El Mansouri, B., El Bachir, A., Amarir, F., El Bissati, K., Holfels, E., Penn, R., Cohen, W., de-la-Torre, A., Britton, G., Motta, J., Ortega-Barria, E., Romero, I. L., Meier, P., Grigg, M., Gómez-Marín, J., Kosagisharaf, J. R., Llorens, X. S., Reyes, O., McLeod, R. 2022; 10 (3): 93-108

  Abstract

  Review work to create and evaluate educational materials that could serve as a primary prevention strategy to help both providers and patients in Panama, Colombia, and the USA reduce disease burden of Toxoplasma infections.Educational programs had not been evaluated for efficacy in Panama, USA, or Colombia.Educational programs for high school students, pregnant women, medical students and professionals, scientists, and lay personnel were created. In most settings, short-term effects were evaluated. In Panama, Colombia, and USA, all materials showed short-term utility in transmitting information to learners. These educational materials can serve as a component of larger public health programs to lower disease burden from congenital toxoplasmosis. Future priorities include conducting robust longitudinal studies of whether education correlates with reduced adverse disease outcomes, modifying educational materials as new information regarding region-specific risk factors is discovered, and ensuring materials are widely accessible.

  View details for DOI 10.1007/s40124-022-00267-y

  View details for PubMedID 36969368

  View details for PubMedCentralID PMC10035399

• Building Programs to Eradicate Toxoplasmosis Part I: Introduction and Overview. Current pediatrics reports Felín, M. S., Wang, K., Moreira, A., Grose, A., Leahy, K., Zhou, Y., Clouser, F. A., Siddiqui, M., Leong, N., Goodall, P., Michalowski, M., Ismail, M., Christmas, M., Schrantz, S., Caballero, Z., Norero, X., Estripeaut, D., Ellis, D., Raggi, C., Castro, C., Moossazadeh, D., Ramirez, M., Pandey, A., Ashi, K., Dovgin, S., Dixon, A., Li, X., Begeman, I., Heichman, S., Lykins, J., Villalobos-Cerrud, D., Fabrega, L., Montalvo, J. L., Mendivil, C., Quijada, M. R., Fernández-Pirla, S., de La Guardia, V., Wong, D., de Guevara, M. L., Flores, C., Borace, J., García, A., Caballero, N., Rengifo-Herrera, C., de Saez, M. T., Politis, M., Wroblewski, K., Karrison, T., Ross, S., Dogra, M., Dhamsania, V., Graves, N., Kirchberg, M., Mathur, K., Aue, A., Restrepo, C. M., Llanes, A., Guzman, G., Rebellon, A., Boyer, K., Heydemann, P., Noble, A. G., Swisher, C., Rabiah, P., Withers, S., Hull, T., Su, C., Blair, M., Latkany, P., Mui, E., Vasconcelos-Santos, D. V., Villareal, A., Perez, A., Galvis, C. A., Montes, M. V., Perez, N. I., Ramirez, M., Chittenden, C., Wang, E., Garcia-López, L. L., Muñoz-Ortiz, J., Rivera-Valdivia, N., Bohorquez-Granados, M. C., de-la-Torre, G. C., Padrieu, G., Hernandez, J. D., Celis-Giraldo, D., Dávila, J. A., Torres, E., Oquendo, M. M., Arteaga-Rivera, J. Y., Nicolae, D. L., Rzhetsky, A., Roizen, N., Stillwaggon, E., Sawers, L., Peyron, F., Wallon, M., Chapey, E., Levigne, P., Charter, C., De Frias, M., Montoya, J., Press, C., Ramirez, R., Contopoulos-Ioannidis, D., Maldonado, Y., Liesenfeld, O., Gomez, C., Wheeler, K., Holfels, E., Frim, D., McLone, D., Penn, R., Cohen, W., Zehar, S., McAuley, J., Limonne, D., Houze, S., Abraham, S., Piarroux, R., Tesic, V., Beavis, K., Abeleda, A., Sautter, M., El Mansouri, B., El Bachir, A., Amarir, F., El Bissati, K., de-la-Torre, A., Britton, G., Motta, J., Ortega-Barria, E., Romero, I. L., Meier, P., Grigg, M., Gómez-Marín, J., Kosagisharaf, J. R., Llorens, X. S., Reyes, O., McLeod, R. 2022; 10 (3): 57-92

  Abstract

  Review building of programs to eliminate Toxoplasma infections.Morbidity and mortality from toxoplasmosis led to programs in USA, Panama, and Colombia to facilitate understanding, treatment, prevention, and regional resources, incorporating student work.Studies foundational for building recent, regional approaches/programs are reviewed. Introduction provides an overview/review of programs in Panamá, the United States, and other countries. High prevalence/risk of exposure led to laws mandating testing in gestation, reporting, and development of broad-based teaching materials about Toxoplasma. These were tested for efficacy as learning tools for high-school students, pregnant women, medical students, physicians, scientists, public health officials and general public. Digitized, free, smart phone application effectively taught pregnant women about toxoplasmosis prevention. Perinatal infection care programs, identifying true regional risk factors, and point-of-care gestational screening facilitate prevention and care. When implemented fully across all demographics, such programs present opportunities to save lives, sight, and cognition with considerable spillover benefits for individuals and societies.The online version contains supplementary material available at 10.1007/s40124-022-00269-w.

  View details for DOI 10.1007/s40124-022-00269-w

  View details for PubMedID 36034212

  View details for PubMedCentralID PMC9395898

• Building Programs to Eradicate Toxoplasmosis Part I: Introduction and Overview CURRENT PEDIATRICS REPORTS Felin, M., Wang, K., Moreira, A., Grose, A., Leahy, K., Zhou, Y., Clouser, F., Siddiqui, M., Leong, N., Goodall, P., Michalowski, M., Ismail, M., Christmas, M., Schrantz, S., Caballero, Z., Norero, X., Estripeaut, D., Ellis, D., Raggi, C., Castro, C., Moossazadeh, D., Ramirez, M., Pandey, A., Ashi, K., Dovgin, S., Dixon, A., Li, X., Begeman, I., Heichman, S., Lykins, J., Fabrega, L., Montalvo, J., Mendivil, C., Quijada, M. R., Fernandez-Pirla, S., de La Guardia, V., Wong, D., Ladron de Guevara, M., Flores, C., Borace, J., Garcia, A., Caballero, N., Moreno de Saez, M., Politis, M., Wroblewski, K., Karrison, T., Ross, S., Dogra, M., Dhamsania, V., Graves, N., Kirchberg, M., Mathur, K., Aue, A., Restrepo, C. M., Llanes, A., Guzman, G., Rebellon, A., Boyer, K., Heydemann, P., Noble, A., Swisher, C., Rabiah, P., Withers, S., Hull, T., Su, C., Blair, M., Latkany, P., Mui, E., Vasconcelos-Santos, D., Villareal, A., Perez, A., Naranjo Galvis, C., Vargas Montes, M., Cardona Perez, N., Ramirez, M., Chittenden, C., Wang, E., Padrieu, G., Valencia Hernandez, J., Acosta Davila, J., Torres, E., Mejia Oquendo, M., Nicolae, D. L., Rzhetsky, A., Roizen, N., Stillwaggon, E., Sawers, L., Peyron, F., Wallon, M., Chapey, E., Levigne, P., Charter, C., De Frias, M., Montoya, J., Press, C., Ramirez, R., Maldonado, Y., Liesenfeld, O., Gomez, C., Wheeler, K., Holfels, E., Frim, D., McLone, D., Penn, R., Cohen, W., Zehar, S., McAuley, J., Limonne, D., Houze, S., Abraham, S., Piarroux, R., Tesic, V., Beavis, K., Abeleda, A., Sautter, M., El Mansouri, B., El Bachir, A., Amarir, F., El Bissati, K., Britton, G., Motta, J., Ortega-Barria, E., Luz Romero, I., Meier, P., Grigg, M., Gomez-Marin, J., Rao Kosagisharaf, J., Saez Llorens, X., Reyes, O., McLeod, R. 2022

  View details for DOI 10.1007/s40124-022-00269-w

  View details for Web of Science ID 000842848600001

• Building Programs to Eradicate Toxoplasmosis Part IV: Understanding and Development of Public Health Strategies and Advances "Take a Village". Current pediatrics reports Felin, M. S., Wang, K., Moreira, A., Grose, A., Leahy, K., Zhou, Y., Clouser, F. A., Siddiqui, M., Leong, N., Goodall, P., Michalowski, M., Ismail, M., Christmas, M., Schrantz, S., Caballero, Z., Norero, X., Estripeaut, D., Ellis, D., Raggi, C., Castro, C., Moossazadeh, D., Ramirez, M., Pandey, A., Ashi, K., Dovgin, S., Dixon, A., Li, X., Begeman, I., Heichman, S., Lykins, J., Villalobos-Cerrud, D., Fabrega, L., Montalvo, J. L., Mendivil, C., Quijada, M. R., Fernandez-Pirla, S., de La Guardia, V., Wong, D., de Guevara, M. L., Flores, C., Borace, J., Garcia, A., Caballero, N., Rengifo-Herrera, C., de Saez, M. T., Politis, M., Ross, S., Dogra, M., Dhamsania, V., Graves, N., Kirchberg, M., Mathur, K., Aue, A., Restrepo, C. M., Llanes, A., Guzman, G., Rebellon, A., Boyer, K., Heydemann, P., Noble, A. G., Swisher, C., Rabiah, P., Withers, S., Hull, T., Frim, D., McLone, D., Su, C., Blair, M., Latkany, P., Mui, E., Vasconcelos-Santos, D. V., Villareal, A., Perez, A., Galvis, C. A., Montes, M. V., Perez, N. I., Ramirez, M., Chittenden, C., Wang, E., Garcia-Lopez, L. L., Padrieu, G., Munoz-Ortiz, J., Rivera-Valdivia, N., Bohorquez-Granados, M. C., de-la-Torre, G. C., Hernandez, J. D., Celis-Giraldo, D., Davila, J. A., Torres, E., Oquendo, M. M., Arteaga-Rivera, J. Y., Nicolae, D. L., Rzhetsky, A., Roizen, N., Stillwaggon, E., Sawers, L., Peyron, F., Wallon, M., Chapey, E., Levigne, P., Charter, C., De Frias, M., Montoya, J., Press, C., Ramirez, R., Contopoulos-Ioannidis, D., Maldonado, Y., Liesenfeld, O., Gomez, C., Wheeler, K., Zehar, S., McAuley, J., Limonne, D., Houze, S., Abraham, S., Piarroux, R., Tesic, V., Beavis, K., Abeleda, A., Sautter, M., El Mansouri, B., El Bachir, A., Amarir, F., El Bissati, K., Holfels, E., Frim, D., McLone, D., Penn, R., Cohen, W., de-la-Torre, A., Britton, G., Motta, J., Ortega-Barria, E., Romero, I. L., Meier, P., Grigg, M., Gomez-Marin, J., Kosagisharaf, J. R., Llorens, X. S., Reyes, O., McLeod, R. 2022: 1-30

  Abstract

  Purpose of Review: Review international efforts to build a global public health initiative focused on toxoplasmosis with spillover benefits to save lives, sight, cognition and motor function benefiting maternal and child health.Recent Findings: Multiple countries' efforts to eliminate toxoplasmosis demonstrate progress and context for this review and new work.Summary: Problems with potential solutions proposed include accessibility of accurate, inexpensive diagnostic testing, pre-natal screening and facilitating tools, missed and delayed neonatal diagnosis, restricted access, high costs, delays in obtaining medicines emergently, delayed insurance pre-approvals and high medicare copays taking considerable physician time and effort, harmful shortcuts being taken in methods to prepare medicines in settings where access is restricted, reluctance to perform ventriculoperitoneal shunts promptly when needed without recognition of potential benefit, access to resources for care, especially for marginalized populations, and limited use of recent advances in management of neurologic and retinal disease which can lead to good outcomes.Supplementary Information: The online version contains supplementary material available at 10.1007/s40124-022-00268-x.

  View details for DOI 10.1007/s40124-022-00268-x

  View details for PubMedID 35991908

• Building Programs to Eradicate Toxoplasmosis Part II: Education CURRENT PEDIATRICS REPORTS Felin, M., Wang, K., Moreira, A., Grose, A., Leahy, K., Zhou, Y., Clouser, F., Siddiqui, M., Leong, N., Goodall, P., Michalowski, M., Ismail, M., Christmas, M., Schrantz, S., Caballero, Z., Norero, X., Estripeaut, D., Ellis, D., Raggi, C., Castro, C., Rengifo-Herrera, C., Moossazadeh, D., Ramirez, M., Pandey, A., Ashi, K., Dovgin, S., Dixon, A., Li, X., Begeman, I., Heichman, S., Lykins, J., Villalobos-Cerrud, D., Fabrega, L., Montalvo, J., Mendivil, C., Quijada, M. R., Fernandez-Pirla, S., de La Guardia, V., Wong, D., de Guevara, M., Flores, C., Borace, J., Garcia, A., Caballero, N., de Saez, M., Politis, M., Ross, S., Dogra, M., Dhamsania, V., Graves, N., Kirchberg, M., Mathur, K., Aue, A., Restrepo, C. M., Llanes, A., Guzman, G., Rebellon, A., Boyer, K., Heydemann, P., Noble, A., Swisher, C., Rabiah, P., Withers, S., Hull, T., Frim, D., McLone, D., Su, C., Blair, M., Latkany, P., Mui, E., Vasconcelos-Santos, D., Villareal, A., Perez, A., Galvis, C., Montes, M., Perez, N., Ramirez, M., Chittenden, C., Wang, E., Garcia-Lopez, L., Munoz-Ortiz, J., Rivera-Valdivia, N., Bohorquez-Granados, M., de-la-Torre, G., Padrieu, G., Hernandez, J., Celis-Giraldo, D., Davila, J., Torres, E., Oquendo, M., Arteaga-Rivera, J. Y., Nicolae, D. L., Rzhetsky, A., Roizen, N., Stillwaggon, E., Sawers, L., Peyron, F., Wallon, M., Chapey, E., Levigne, P., Charter, C., De Frias, M., Montoya, J., Press, C., Ramirez, R., Contopoulos-Ioannidis, D., Maldonado, Y., Liesenfeld, O., Gomez, C., Wheeler, K., Zehar, S., McAuley, J., Limonne, D., Houze, S., Abraham, S., Piarroux, R., Tesic, V., Beavis, K., Abeleda, A., Sautter, M., El Mansouri, B., El Bachir, A., Amarir, F., El Bissati, K., Holfels, E., Penn, R., Cohen, W., de-la-Torre, A., Britton, G., Motta, J., Ortega-Barria, E., Romero, I., Meier, P., Grigg, M., Gomez-Marin, J., Kosagisharaf, J., Llorens, X., Reyes, O., McLeod, R. 2022

  View details for DOI 10.1007/s40124-022-00267-y

  View details for Web of Science ID 000834751600001

• Effectiveness of vaccination mandates in improving uptake of COVID-19 vaccines in the USA. Lancet (London, England) Mello, M. M., Opel, D. J., Benjamin, R. M., Callaghan, T., DiResta, R., Elharake, J. A., Flowers, L. C., Galvani, A. P., Salmon, D. A., Schwartz, J. L., Brewer, N. T., Buttenheim, A. M., Carpiano, R. M., Clinton, C., Hotez, P. J., Lakshmanan, R., Maldonado, Y. A., Omer, S. B., Sharfstein, J. M., Caplan, A. 2022

  View details for DOI 10.1016/S0140-6736(22)00875-3

  View details for PubMedID 35817078

• Building Programs to Eradicate Toxoplasmosis Part III: Epidemiology and Risk Factors CURRENT PEDIATRICS REPORTS Felin, M., Wang, K., Raggi, C., Moreira, A., Pandey, A., Grose, A., Caballero, Z., Rengifo-Herrera, C., Ramirez, M., Moossazadeh, D., Castro, C., Montalvo, J., Leahy, K., Zhou, Y., Clouser, F., Siddiqui, M., Leong, N., Goodall, P., Michalowski, M., Ismail, M., Christmas, M., Schrantz, S., Norero, X., Estripeaut, D., Ellis, D., Ashi, K., Dovgin, S., Dixon, A., Li, X., Begeman, I., Heichman, S., Lykins, J., Villalobos-Cerrud, D., Fabrega, L., Mendivil, C., Quijada, M. R., Fernandez-Pirla, S., de La Guardia, V., Wong, D., de LadronGuevara, M., Flores, C., Borace, J., Garcia, A., Caballero, N., de Saez, M., Politis, M., Ross, S., Dogra, M., Dhamsania, V., Graves, N., Kirchberg, M., Mathur, K., Aue, A., Restrepo, C. M., Llanes, A., Guzman, G., Rebollon, A., Boyer, K., Heydemann, P., Noble, A., Swisher, C., Rabiah, P., Withers, S., Hull, T., Su, C., Blair, M., Latkany, P., Mui, E., Vasconcelos-Santos, D., Villareal, A., Perez, A., Galvis, C., Montes, M., Perez, N., Ramirez, M., Chittenden, C., Wang, E., Lorena Garcia-Lopez, L., Munoz-Ortiz, J., Rivera-Valdivia, N., Bohorquez-Granados, M., de-la-Torre, G., Padrieu, G., Hernandez, J., Celis-Giraldo, D., Davila, J., Torres, E., Oquendo, M., Arteaga-Rivera, J. Y., Nicolae, D., Rzhetsky, A., Roizen, N., Stillwaggon, E., Sawers, L., Peyron, F., Wallon, M., Chapey, E., Levigne, P., Charter, C., De Frias, M., Montoya, J., Press, C., Ramirez, R., Contopoulos-Ioannidis, D., Maldonado, Y., Liesenfeld, O., Gomez, C., Wheeler, K., Holfels, E., Frim, D., McLone, D., Penn, R., Cohen, W., Zehar, S., McAuley, J., Limonne, D., Houze, S., Abraham, S., Piarroux, R., Tesic, V., Beavis, K., Abeleda, A., Sautter, M., El Mansouri, B., El Bachir, A., Amarir, F., El Bissati, K., de-la-Torre, A., Britton, G., Motta, J., Ortega-Barria, E., Romero, I., Meier, P., Grigg, M., Gomez-Marin, J., Rao Kosagisharaf, J., Llorens, X., Reyes, O., McLeod, R. 2022

  View details for DOI 10.1007/s40124-022-00265-0

  View details for Web of Science ID 000814479300001

• Global Health Needs Modernized Containment Strategies to Prepare for the Next Pandemic. Frontiers in public health Seetah, K., Moots, H., Pickel, D., Van Cant, M., Cianciosi, A., Mordecai, E., Cullen, M., Maldonado, Y. 2022; 10: 834451

  Abstract

  COVID-19 continues to be a public health crisis, while severely impacting global financial markets causing significant economic and social hardship. As with any emerging disease, pharmaceutical interventions required time, emphasizing the initial and continuing need for non-pharmaceutical interventions. We highlight the role of anthropological and historical perspectives to inform approaches to non-pharmaceutical interventions for future preparedness. The National Academy of Medicine, a not-for-profit, non-governmental US-based medical watchdog organization, published a key document early in the COVID-19 pandemic which points to inadequate quarantine and containment infrastructure as a significant obstacle to an effective pandemic response. In considering how to implement effective quarantine policies and infrastructure, we argue that it is essential to take a longitudinal approach to assess interventions that have been effective in past pandemics while simultaneously addressing and eliminating the negative socio-historical legacies of ineffective quarantine practices. Our overview reinforces the need for social equity and compassion when implementing containment.

  View details for DOI 10.3389/fpubh.2022.834451

  View details for PubMedID 35769777

  View details for PubMedCentralID PMC9234159

• Rebuilding child health in South Kivu, Democratic Republic of Congo (DRC): evaluating the Asili social enterprise program. Conflict and health Behl, R., Ali, S., Altamirano, J., Leno, A., Maldonado, Y., Sarnquist, C. 2022; 16 (1): 21

  Abstract

  The Democratic Republic of Congo (DRC) has a long history of conflict and ongoing local instability; the eastern provinces, including South Kivu, have been especially affected. Health systems and livelihoods have been undermined, contributing to massive inequities in access to health services and high rates of internal displacement. Asili, an innovative social enterprise program, aimed to provide essential community services and improve the health of under-five children in two South Kivu communities, Mudaka and Panzi, via provision of small-format, franchisable health clinics and clean water services.We evaluated utilization and acceptance of Asili services in two study sites, Mudaka and Panzi. Data collected included questions on housing conditions, food security, and at follow up, Asili membership and use, satisfaction with services, and recommendations for improvement. Structured pre- and post-interviews with primary caregivers of families with under-five children were the primary source of data with additional community input collected through focus group discussions.At baseline, we enrolled 843 households in Mudaka and 890 in Panzi. Market segmentation analysis illuminated service usage patterns, showing Asili services were well received overall in both Mudaka and Panzi. Families reporting higher levels of proxy measures of socioeconomic status (SES), such as electricity, land ownership, and education, were more likely to use Asili services, findings that were further supported by focus group discussions among community members.Rebuilding health infrastructure in post-conflict settings, especially those that continue to be conflict-affected and very low SES, is a challenging prospect. Focus group results for this study highlighted the positive community response to Asili, while also underscoring challenges related to cost of services. Programs may need, in particular, to have different levels of costs for different SES groups. Additionally, longer follow-up periods and increased stability may be needed to assess the potential of social enterprise interventions such as Asili to improve health outcomes, especially in children.Institutional Review Board approval for this study was obtained at Stanford University (IRB 35216) and the University of Kinshasa, DRC. Further, this study has been registered on Clinicaltrials.gov (record NCT03536286), retrospectively registered as of 4/23/2018.

  View details for DOI 10.1186/s13031-022-00454-0

  View details for PubMedID 35526031

• Assessment of Bias in Patient Safety Reporting Systems Categorized by Physician Gender, Race and Ethnicity, and Faculty Rank: A Qualitative Study. JAMA network open Burton, E., Flores, B., Jerome, B., Baiocchi, M., Min, Y., Maldonado, Y. A., Fassiotto, M. 2022; 5 (5): e2213234

  Abstract

  Importance: Patient safety reporting systems (PSRSs) are designed to decrease the risk of harm to patients due to medical errors. Owing to the voluntary nature of PSRSs, implicit bias of the reporter may affect the management of safety events reported. Stanford Alert For Events (SAFE) is the PSRS used at Stanford Health Care.Objective: To examine whether variation exists in the content of SAFE reports based on demographic characteristics of physicians who are the subject of the event report.Design, Setting, and Participants: This retrospective qualitative analysis from a single academic medical center evaluated SAFE reports from March 2011 to February 2020. Event reports were coded by theme and categorized by severity (scale of 1 to 3, with 1 being the lowest and 3 the highest). The reports were then analyzed from October 2020 to February 2022 and categorized by physician gender, race and ethnicity, and faculty rank. A total of 501 patient safety events were collected from the adult hospital during the study period, and 100 were excluded owing to incompleteness of information.Main Outcomes and Measures: This qualitative study had no planned outcome.Results: A qualitative analysis was performed on 401 reports representing 187 physicians (138 [73.8%] male and 49 [26.2%] female). In terms of race and ethnicity, 4 physicians (2.1%) were African American, 49 (26.2%) were Asian; 7 (3.7%), Hispanic or Latinx; 108 (57.7%), White; and 19 (10.2%), declined to state. Female physicians had disproportionate representation among reports referencing communication and conversational issues and the lowest severity level. Male physicians had disproportionate representation for ignoring or omitting procedures, process issues, and physical intimidation. African American physicians had disproportionate representation for lack of communication and process issues. Asian physicians had disproportionate representation for lack of communication, process issues, conversational conduct, and the lowest severity level. Latinx physicians had disproportionate representation for conversational conduct. White physicians had disproportionate representation for ignoring or omitting procedures, verbal abuse, physical intimidation, and the highest severity level.Conclusions and Relevance: In this qualitative study, female physicians and physicians who were members of racial and ethnic minority groups were more likely to be reported for low-severity communication issues compared with their male and White counterparts, respectively. These findings suggest that there may be a lower threshold for reporting events when the subject of the report is female and/or a member of a racial or ethnic minority group. Restructuring the reporting and management of patient safety events may be needed to facilitate conflict resolution in a manner that reduces implicit bias and fosters team cohesion.

  View details for DOI 10.1001/jamanetworkopen.2022.13234

  View details for PubMedID 35594045

• Prospective Pilot Study Evaluating SARS-CoV-2 Transmission-Limiting Measures in an On-Site School ACADEMIC PEDIATRICS Jani, S. G., Ma, J., Pulendran, U., Hsing, J. C., Altamirano, J., Shah, S., Toomarian, E. Y., Maldonado, Y., Wang, C. 2022; 22 (4): 671-679

  View details for Web of Science ID 000832839400022

• Favipiravir for treatment of outpatients with asymptomatic or uncomplicated COVID-19: a double-blind randomized, placebo-controlled, phase 2 trial. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Holubar, M., Subramanian, A., Purington, N., Hedlin, H., Bunning, B., Walter, K. S., Bonilla, H., Boumis, A., Chen, M., Clinton, K., Dewhurst, L., Epstein, C., Jagannathan, P., Kaszynski, R. H., Panu, L., Parsonnet, J., Ponder, E. L., Quintero, O., Sefton, E., Singh, U., Soberanis, L., Truong, H., Andrews, J. R., Desai, M., Khosla, C., Maldonado, Y. 2022

  Abstract

  Favipiravir is an oral, RNA-dependent RNA polymerase inhibitor with in vitro activity against SARS-CoV2. Despite limited data, favipiravir is administered to patients with COVID-19 in several countries.We conducted a phase 2 double-blind randomized controlled outpatient trial of favipiravir in asymptomatic or mildly symptomatic adults with a positive SARS-CoV2 RT-PCR within 72 hours of enrollment. Participants were randomized 1: 1 to receive placebo or favipiravir (1800mg BID Day 1, 800 mg BID Days 2-10). The primary outcome was SARS-CoV-2 shedding cessation in a modified intention-to-treat (mITT) cohort of participants with positive enrollment RT-PCRs. Using SARS-CoV-2 amplicon-based sequencing, we assessed favipiravir's impact on mutagenesis.From July 8, 2020 - March 23, 2021, we randomized 149 participants with 116 included in the mITT cohort. The participants' mean age was 43 years (SD 12.5) and 57 (49%) were women. We found no difference in time to shedding cessation by treatment arm overall (HR 0.76 favoring placebo, 95% confidence interval [CI] 0.48-1.20) or in sub-group analyses (age, sex, high-risk comorbidities, seropositivity or symptom duration at enrollment). We observed no difference in time to symptom resolution (initial: HR 0.84, 95% CI 0.54-1.29; sustained: HR 0.87, 95% CI 0.52-1.45). We detected no difference in accumulation of transition mutations in the viral genome during treatment.Our data do not support favipiravir use at commonly used doses in outpatients with uncomplicated COVID-19. Further research is needed to ascertain if higher doses of favipiravir are effective and safe for patients with COVID-19.

  View details for DOI 10.1093/cid/ciac312

  View details for PubMedID 35446944

• Achieving equity through science and integrity: dismantling race-based medicine. Pediatric research Wright, J. L., Freed, G. L., Hendricks-Munoz, K. D., Jarvis, J. N., Maldonado, Y. A., Raphael, J. L., Schnadower, D., Sims, B., Bogue, C. W., Leonard, M. B., Coyne-Beasley, T. D., Committee on Diversity, I. a., Wright, J. L., Freed, G. L., Hendricks-Munoz, K. D., Jarvis, J. N., Maldonado, Y. A., Raphael, J. L., Schnadower, D., Sims, B., Bogue, C. W., Leonard, M. B., Coyne-Beasley, T. D. 2022

  View details for DOI 10.1038/s41390-022-02041-8

  View details for PubMedID 35383261

• Incentives for COVID-19 vaccination. Lancet Regional Health. Americas Brewer, N. T., Buttenheim, A. M., Clinton, C. V., Mello, M. M., Benjamin, R. M., Callaghan, T., Caplan, A., Carpiano, R. M., DiResta, R., Elharake, J. A., Flowers, L. C., Galvani, A. P., Hotez, P. J., Lakshmanan, R., Maldonado, Y. A., Omer, S. B., Salmon, D. A., Schwartz, J. L., Sharfstein, J. M., Opel, D. J. 2022; 8: 100205

  View details for DOI 10.1016/j.lana.2022.100205

  View details for PubMedID 35229080

• Incidence and prevalence of COVID-19 within a healthcare worker cohort during the first year of the SARS-CoV-2 pandemic. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Doernberg, S. B., Holubar, M., Jain, V., Weng, Y., Lu, D., Bollyky, J. B., Sample, H., Huang, B., Craik, C. S., Desai, M., Rutherford, G. W., Maldonado, Y., CHART Study Consortium 2022

  Abstract

  BACKGROUND: Preventing SARS-CoV2 infections in healthcare workers (HCWs) is critical for healthcare delivery. We aimed to estimate and characterize the prevalence and incidence of COVID-19 in a US HCW cohort and to identify risk factors associated with infection.METHODS: We conducted a longitudinal cohort study of HCWs at 3 Bay Area medical centers using serial surveys and SARS-CoV-2 viral and orthogonal serological testing, including measurement of neutralizing antibodies. We estimated baseline prevalence and cumulative incidence of COVID-19. We performed multivariable Cox proportional hazards models to estimate associations of baseline factors with incident infections and evaluated the impact of time-varying exposures on time to COVID-19 using marginal structural models.RESULTS: 2435 HCWs contributed 768 person years of follow-up time. We identified 21/2435 individuals with prevalent infection, resulting in a baseline prevalence of 0.86% (95% CI, 0.53% to 1.32%). We identified 70/2414 (2.9%) incident infections yielding a cumulative incidence rate of 9.11 cases per 100 person years (95% CI 7.11 to 11.52). Community contact with a known COVID-19 case most strongly correlated with increased hazard for infection (HR 8.1, 95% CI, 3.8, 17.5). High-risk work-related exposures (i.e., breach in protective measures) drove an association between work exposure and infection (HR 2.5, 95% CI, 1.3-4.8). More cases were identified in HCW when community case rates were high.CONCLUSION: We observed modest COVID-19 incidence despite consistent exposure at work. Community contact was strongly associated with infections but contact at work was not unless accompanied by high-risk exposure.

  View details for DOI 10.1093/cid/ciac210

  View details for PubMedID 35279023

• Infectious Diseases-Related Hospitalizations During Oral Polio Vaccine(OPV) and non-OPV immunization periods: An Empirical Evaluation of all Hospital Discharges in California(1985-2010). Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Contopoulos-Ioannidis, D. G., Altamirano, J., Maldonado, Y. 2022

  Abstract

  BACKGROUND: Live attenuated vaccines such as oral polio vaccine (OPV) can stimulate innate immunity and may have off-target protective effects on other pathogens. We aimed to address this hypothesis by examining changes in infectious diseases (ID)-related hospitalizations in all hospital discharges in California during OPV-(1985-1996) and non-OPV-immunization periods (2000-2010).METHODS: We searched the OSHPD (Office of Statewide Health Planning and Development) database for all hospital discharges with any ID-related discharge diagnosis code during 1985-2010. We compared the proportion of ID-related hospitalizations (with at least one ID-related discharge diagnosis) among total hospitalizations during OPV immunization (1985-1996) vs non-OPV immunization (2000-2010) periods.RESULTS: There were 19,281,039 ID-related hospitalizations (8,464,037 with an ID-related discharge-diagnosis as the principal discharge diagnosis for the hospitalization) among 98,117,475 hospitalizations in 1985-2010; 9,520,810 ID-hospitalizations/43,456,484 total hospitalizations in 2000-2010 vs 7,526,957/43,472,796 in 1985-1996. The RR for ID-related hospitalizations in 2000-2010 vs 1985-1996 was 1.27(95% CI: 1.26-1.27) for all diagnoses and 1.15(95% CI: 1.15-1.16) for principal diagnoses. Increases also existed in the proportion of lower respiratory and gastrointestinal infections.DISCUSSION: The proportion of ID-related hospitalizations was lower in the OPV-immunization period compared to the period after OPV was discontinued. When focused only on hospitalizations with ID as the principal discharge diagnosis the signal remained significant but was smaller. These findings require replication in additional studies.

  View details for DOI 10.1093/cid/ciac114

  View details for PubMedID 35139187

• Vaccine Verification in the COVID-19 World. Lancet Regional Health. Americas Salmon, D. A., Elharake, J. A., Brewer, N. T., Carpiano, R. M., DiResta, R., Maldonado, Y. A., Sgaier, S. K., Omer, S. B., Lancet Commission on Vaccine Refusal, A. 1800; 6: 100161

  View details for DOI 10.1016/j.lana.2021.100161

  View details for PubMedID 34961857

• Early non-neutralizing, afucosylated antibody responses are associated with COVID-19 severity. Science translational medicine Chakraborty, S., Gonzalez, J. C., Sievers, B. L., Mallajosyula, V., Chakraborty, S., Dubey, M., Ashraf, U., Cheng, B. Y., Kathale, N., Tran, K. Q., Scallan, C., Sinnott, A., Cassidy, A., Chen, S. T., Gelbart, T., Gao, F., Golan, Y., Ji, X., Kim-Schulze, S., Prahl, M., Gaw, S. L., Gnjatic, S., Marron, T. U., Merad, M., Arunachalam, P. S., Boyd, S. D., Davis, M. M., Holubar, M., Khosla, C., Maecker, H. T., Maldonado, Y., Mellins, E. D., Nadeau, K. C., Pulendran, B., Singh, U., Subramanian, A., Utz, P. J., Sherwood, R., Zhang, S., Jagannathan, P., Tan, G. S., Wang, T. T. 1800: eabm7853

  Abstract

  A damaging inflammatory response is implicated in the pathogenesis of severe coronavirus disease 2019 (COVID-19), but mechanisms contributing to this response are unclear. In two prospective cohorts, early non-neutralizing, afucosylated IgG antibodies specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were associated with progression from mild to more severe COVID-19. In contrast to the antibody structures that were associated with disease progression, antibodies that were elicited by mRNA SARS-CoV-2 vaccines were instead highly fucosylated and enriched in sialylation, both modifications that reduce the inflammatory potential of IgG. To study the biology afucosylated IgG immune complexes, we developed an in vivo model that revealed that human IgG-Fc gamma receptor (FcgammaR) interactions could regulate inflammation in the lung. Afucosylated IgG immune complexes isolated from COVID-19 patients induced inflammatory cytokine production and robust infiltration of the lung by immune cells. By contrast, vaccine-elicited IgG did not promote an inflammatory lung response. Together, these results show that IgG-FcgammaR interactions are able to regulate inflammation in the lung and may define distinct lung activities associated with the IgG that are associated with severe COVID-19 and protection against infection with SARS-CoV-2.

  View details for DOI 10.1126/scitranslmed.abm7853

  View details for PubMedID 35040666

• Feasibility of Specimen Self-collection in Young Children Undergoing SARS-CoV-2 Surveillance for In-Person Learning. JAMA network open Altamirano, J., Lopez, M., Robinson, I. G., Chun, L. X., Tam, G. K., Shaikh, N. J., Hoyte, E. G., Carrington, Y. J., Jani, S. G., Toomarian, E. Y., Hsing, J. C., Ma, J., Pulendran, U., Govindarajan, P., Blomkalns, A. L., Pinsky, B. A., Wang, C. J., Maldonado, Y. 2022; 5 (2): e2148988

  Abstract

  There is an urgent need to assess the feasibility of COVID-19 surveillance measures in educational settings.To assess whether young children can feasibly self-collect SARS-CoV-2 samples for surveillance testing over the course of an academic year.This prospective pilot cohort study was conducted from September 10, 2020, to June 10, 2021, at a K-8 school in San Mateo County, California. The research consisted of quantitative data collection efforts: (1) demographic data collected, (2) student sample self-collection error rates, and (3) student sample self-collection time durations. Students were enrolled in a hybrid learning model, a teaching model in which students were taught in person and online, with students having the option to attend virtually as needed. Data were collected under waiver of consent from students participating in weekly SARS-CoV-2 testing.Errors over time for self-collection of nasal swabs such as contaminated swabs and inadequate or shallow swabbing; time taken for sample collection.Of 296 participants, 148 (50.0%) were boys and 148 (50.0%) were girls. A total of 87 participants (29.2%) identified as Asian; 2 (0.6%), Black or African American; 13 (4.4%), Hispanic/Latinx; 103 (34.6%), non-Hispanic White; 87 (29.2%), multiracial; and 6 (2.0%), other. The median school grade was fourth grade. From September 2020 to March 2021, a total of 4203 samples were obtained from 221 students on a weekly basis, while data on error rates were collected. Errors occurred in 2.7% (n = 107; 95% CI, 2.2%-3.2%) of student encounters, with the highest rate occurring on the first day of testing (20 [10.2%]). There was an overall decrease in error rates over time. From April to June 2021, a total of 2021 samples were obtained from 296 students on a weekly basis while data on encounter lengths were collected. Between April and June 2021, 193 encounters were timed. The mean duration of each encounter was 70 seconds (95% CI, 66.4-73.7 seconds).Mastery of self-collected lower nasal swabs is possible for children 5 years and older. Testing duration can be condensed once students gain proficiency in testing procedures. Scalability for larger schools is possible if consideration is given to the resource-intensive nature of the testing and the setting's weather patterns.

  View details for DOI 10.1001/jamanetworkopen.2021.48988

  View details for PubMedID 35175340

• Long Term Accuracy of SARS-CoV-2 Interferon-γ Release Assay and its Application in Household Investigation. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Murugesan, K., Jagannathan, P., Altamirano, J., Maldonado, Y. A., Bonilla, H. F., Jacobson, K. B., Parsonnet, J., Andrews, J. R., Shi, R. Z., Boyd, S., Pinsky, B. A., Singh, U., Banaei, N. 2022

  Abstract

  An immunodiagnostic assay that sensitively detects a cell-mediated immune response to SARS-CoV-2 is needed for epidemiological investigation and for clinical assessment of T cell-mediated immune response to vaccines, particularly in the context of emerging variants that might escape antibody responses.The performance of a whole blood interferon-gamma (IFN-γ) release assay (IGRA) for the detection of SARS-CoV-2 antigen-specific T cells was evaluated in COVID-19 convalescents tested serially up to 10 months post-infection and in healthy blood donors. SARS-CoV-2 IGRA was applied in contacts of households with index cases. Freshly collected blood in the lithium heparin tube was left unstimulated, stimulated with a SARS-CoV-2 peptide pool, and stimulated with mitogen.The overall sensitivity and specificity of IGRA were 84.5% (153/181; 95% confidence interval [CI] 79.0-89.0) and 86.6% (123/142; 95% CI;80.0-91.2), respectively. The sensitivity declined from 100% (16/16; 95% CI 80.6-100) at 0.5-month post-infection to 79.5% (31/39; 95% CI 64.4-89.2) at 10 months post-infection (P<0.01). The IFN-γ response remained relatively robust at 10 months post-infection (3.8 vs. 1.3 IU/mL, respectively). In 14 households, IGRA showed a positivity rate of 100% (12/12) and 65.2% (15/23), and IgG of 50.0% (6/12) and 43.5% (10/23) in index cases and contacts, respectively, exhibiting a difference of +50% (95% CI +25.4-+74.6) and +21.7% (95% CI, +9.23-+42.3), respectively. Either IGRA or IgG was positive in 100% (12/12) of index cases and 73.9% (17/23) of contacts.The SARS-CoV-2 IGRA is a useful clinical diagnostic tool for assessing cell-mediated immune response to SARS-CoV-2.

  View details for DOI 10.1093/cid/ciac045

  View details for PubMedID 35079772

• Unusual Interseasonal RSV Activity in the Southern and Northern Hemispheres. The Journal of infectious diseases Anglemyer, A., Rutherford, G., Walls, T., Maldonado, Y. 1800

  View details for DOI 10.1093/infdis/jiab620

  View details for PubMedID 34935959

• Vaccine Exemptions and the Risk of Continued Disease Outbreaks. Pediatrics Maldonado, Y. A., O'Leary, S., Hotez, P. 2021

  View details for DOI 10.1542/peds.2021-054369

  View details for PubMedID 34866155

• Race-ethnicity and COVID-19 Vaccination Beliefs and Intentions: A Cross-Sectional Study among the General Population in the San Francisco Bay Area. Vaccines Weng, Y., Lu, D., Bollyky, J., Jain, V., Desai, M., Lindan, C., Boothroyd, D., Judson, T., Doernberg, S. B., Holubar, M., Sample, H., Huang, B., Maldonado, Y., Rutherford, G. W., Grumbach, K., On Behalf Of The California Pandemic Consortium 1800; 9 (12)

  Abstract

  OBJECTIVE: The study was designed to compare intentions to receive COVID-19 vaccination by race-ethnicity, to identify beliefs that may mediate the association between race-ethnicity and intention to receive the vaccine and to identify the demographic factors and beliefs most strongly predictive of intention to receive a vaccine.DESIGN: Cross-sectional survey conducted from November 2020 to January 2021, nested within a longitudinal cohort study of the prevalence and incidence of SARS-CoV-2 among a general population-based sample of adults in six San Francisco Bay Area counties (called TrackCOVID). Study Cohort: In total, 3161 participants among the 3935 in the TrackCOVID parent cohort responded.RESULTS: Rates of high vaccine willingness were significantly lower among Black (41%), Latinx (55%), Asian (58%), Multi-racial (59%), and Other race (58%) respondents than among White respondents (72%). Black, Latinx, and Asian respondents were significantly more likely than White respondents to endorse lack of trust of government and health agencies as a reason not to get vaccinated. Participants' motivations and concerns about COVID-19 vaccination only partially explained racial-ethnic differences in vaccination willingness. Concerns about a rushed government vaccine approval process and potential bad reactions to the vaccine were the two most important factors predicting vaccination intention.CONCLUSIONS: Vaccine outreach campaigns must ensure that the disproportionate toll of COVID-19 on historically marginalized racial-ethnic communities is not compounded by inequities in vaccination. Efforts must emphasize messages that speak to the motivations and concerns of groups suffering most from health inequities to earn their trust to support informed decision making.

  View details for DOI 10.3390/vaccines9121406

  View details for PubMedID 34960152

• Promoting COVID-19 vaccine acceptance: recommendations from the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA. Lancet (London, England) Omer, S. B., Benjamin, R. M., Brewer, N. T., Buttenheim, A. M., Callaghan, T., Caplan, A., Carpiano, R. M., Clinton, C., DiResta, R., Elharake, J. A., Flowers, L. C., Galvani, A. P., Lakshmanan, R., Maldonado, Y. A., McFadden, S. M., Mello, M. M., Opel, D. J., Reiss, D. R., Salmon, D. A., Schwartz, J. L., Sharfstein, J. M., Hotez, P. J. 2021

  Abstract

  Since the first case of COVID-19 was identified in the USA in January, 2020, over 46 million people in the country have tested positive for SARS-CoV-2 infection. Several COVID-19 vaccines have received emergency use authorisations from the US Food and Drug Administration, with the Pfizer-BioNTech vaccine receiving full approval on Aug 23, 2021. When paired with masking, physical distancing, and ventilation, COVID-19 vaccines are the best intervention to sustainably control the pandemic. However, surveys have consistently found that a sizeable minority of US residents do not plan to get a COVID-19 vaccine. The most severe consequence of an inadequate uptake of COVID-19 vaccines has been sustained community transmission (including of the delta [B.1.617.2] variant, a surge of which began in July, 2021). Exacerbating the direct impact of the virus, a low uptake of COVID-19 vaccines will prolong the social and economic repercussions of the pandemic on families and communities, especially low-income and minority ethnic groups, into 2022, or even longer. The scale and challenges of the COVID-19 vaccination campaign are unprecedented. Therefore, through a series of recommendations, we present a coordinated, evidence-based education, communication, and behavioural intervention strategy that is likely to improve the success of COVID-19 vaccine programmes across the USA.

  View details for DOI 10.1016/S0140-6736(21)02507-1

  View details for PubMedID 34793741

• Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. The New England journal of medicine Walter, E. B., Talaat, K. R., Sabharwal, C., Gurtman, A., Lockhart, S., Paulsen, G. C., Barnett, E. D., Munoz, F. M., Maldonado, Y., Pahud, B. A., Domachowske, J. B., Simoes, E. A., Sarwar, U. N., Kitchin, N., Cunliffe, L., Rojo, P., Kuchar, E., Ramet, M., Munjal, I., Perez, J. L., Frenck, R. W., Lagkadinou, E., Swanson, K. A., Ma, H., Xu, X., Koury, K., Mather, S., Belanger, T. J., Cooper, D., Tureci, O., Dormitzer, P. R., Sahin, U., Jansen, K. U., Gruber, W. C., C4591007 Clinical Trial Group 2021

  Abstract

  BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety, immunogenicity, and efficacy of two doses of the BNT162b2 vaccine administered 21 days apart in children 6 months to 11 years of age. We present results for 5-to-11-year-old children. In the phase 2-3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses of either the BNT162b2 vaccine at the dose level identified during the open-label phase 1 study or placebo. Immune responses 1 month after the second dose of BNT162b2 were immunologically bridged to those in 16-to-25-year-olds from the pivotal trial of two 30-mug doses of BNT162b2. Vaccine efficacy against Covid-19 at 7 days or more after the second dose was assessed.RESULTS: During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 mug, 20 mug, or 30 mug of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 mug was selected for further study. In the phase 2-3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18), a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, >0.67; geometric mean ratio point estimate, ≥0.8). Covid-19 with onset 7 days or more after the second dose was reported in three recipients of the BNT162b2 vaccine and in 16 placebo recipients (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3).CONCLUSIONS: A Covid-19 vaccination regimen consisting of two 10-mug doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).

  View details for DOI 10.1056/NEJMoa2116298

  View details for PubMedID 34752019

• The effect of a relationship-centered communication program on patient experience and provider wellness. Patient education and counseling Altamirano, J., Kline, M., Schwartz, R., Fassiotto, M., Maldonado, Y., Weimer-Elder, B. 2021

  Abstract

  OBJECTIVES: Despite evidence of the central importance of communication to patient experience, health outcomes, and provider wellness, communication training for clinicians is not a standard part of clinical education. The study explores the impact of an 8-hour relationship-centered communication (RCC) training program on patient experience and provider wellness.METHODS: 636 healthcare providers participated in 48 workshops conducted January-August 2018. 481 (76%) agreed to participate in research. Participants completed a pre/post assessment that included a wellness survey, the Professional Fulfillment Index (PFI). We conducted chi-squared analyses comparing wellness data immediately prior to the course to 3 months following course participation. Patient experience, assessed using Press Ganey likelihood to recommend care provider (PG-LTR CP) scores, were examined prior to an individual's course participation and following participation up to September 2019.RESULTS: 104 participants completed the three-month PFI (22% response rate). Participants demonstrated marked improvements in professional wellness after 3 months. In bivariate analyses, PG-LTRCP significantly increased and persisted more than 7 months following program completion.CONCLUSIONS: The RCC training program, a low-cost communication intervention, led to significant, beneficial changes in provider wellness and patient experience.PRACTICE IMPLICATIONS: Implementing a RCC course for providers may improve patient experience and provider wellness.

  View details for DOI 10.1016/j.pec.2021.10.025

  View details for PubMedID 34772532

• High Completion of COVID-19 Vaccination Among Health Care Workers Despite Initial Self-Reported Vaccine Reluctance. Open forum infectious diseases Jain, V., Doernberg, S. B., Holubar, M., Huang, B., Bollyky, J., Sample, H., Weng, Y., Lu, D., Desai, M., Maldonado, Y., Rutherford, G. 2021; 8 (10): ofab446

  View details for DOI 10.1093/ofid/ofab446

  View details for PubMedID 34734101

• The COVID-19 Outpatient Pragmatic Platform Study (COPPS): Study design of a multi-center pragmatic platform trial. Contemporary clinical trials Bunning, B., Hedlin, H., Purington, N., Sundaram, V., Kapphahn, K., Weng, Y., Cunanan, K., Maldonado, Y., Singh, U., Khosla, C., O'Hara, R., Nicolls, M., Springman, E., Parsonnet, J., Rogers, A., Levitt, J., Desai, M. 2021: 106509

  Abstract

  More than 3000 clinical trials related to COVID-19 have been registered through clinicaltrials.gov. With so many trials, there is a risk that many will be inconclusive due to being underpowered or due to an inability to recruit patients. At academic medical centers, multiple trials are competing for the same resources; the success of one may come at the expense of another. The COVID-19 Outpatient Pragmatic Protocol Study (COPPS) is a flexible phase 2, multi-site, randomized, blinded trial based at Stanford University designed to overcome these issues by simultaneously evaluating multiple COVID-19 treatments in the outpatient setting in one common platform with shared controls. This approach reduces the overall number of patients required for statistical power, while improving the likelihood that any enrolled patient receives active treatment. The platform study has two main domains designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain), measured with self-collected nasal swabs, or improve clinical outcomes (Clinical Domain), measured through self-reported symptomology data. Data are collected on both domains for all participants enrolled. Participants are followed over a 28-day period. COPPS has the advantage of pragmatism created around its workflow that is also appealing to potential participants because of a lower probability of inactive treatment. At the conclusion of this clinical trial we expect to have identified potentially effective therapeutic strategy/ies for treating COVID-19 in the outpatient setting, which will have a transformative impact on medicine and public health.

  View details for DOI 10.1016/j.cct.2021.106509

  View details for PubMedID 34274494

• Myocarditis after SARS-CoV-2 Vaccination: True, True, andRelated? Pediatrics O'Leary, S. T., Maldonado, Y. A. 2021

  View details for DOI 10.1542/peds.2021-052644

  View details for PubMedID 34088761

• Announcing the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA LANCET Hotez, P. J., USA, L., Cooney, R. E., Benjamin, R. M., Brewer, N. T., Buttenheim, A. M., Callaghan, T., Caplan, A., Carpiano, R. M., Clinton, C., DiResta, R., Elharake, J. A., Flowers, L. C., Galvani, A. P., Lakshmanan, R., Maldonado, Y. A., McFadden, S. M., Mello, M. M., Opel, D. J., Reiss, D. R., Salmon, D. A., Schwartz, J. L., Sharfstein, J. M., Omer, S. B. 2021; 397 (10280): 1165–67

  View details for DOI 10.1016/S0140-6736(21)00372-X

  View details for Web of Science ID 000633010800006

  View details for PubMedID 33639088

• Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial. Nature communications Jagannathan, P. n., Andrews, J. R., Bonilla, H. n., Hedlin, H. n., Jacobson, K. B., Balasubramanian, V. n., Purington, N. n., Kamble, S. n., de Vries, C. R., Quintero, O. n., Feng, K. n., Ley, C. n., Winslow, D. n., Newberry, J. n., Edwards, K. n., Hislop, C. n., Choong, I. n., Maldonado, Y. n., Glenn, J. n., Bhatt, A. n., Blish, C. n., Wang, T. n., Khosla, C. n., Pinsky, B. A., Desai, M. n., Parsonnet, J. n., Singh, U. n. 2021; 12 (1): 1967

  Abstract

  Type III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized, single-blind, placebo-controlled trial (NCT04331899) in 120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint). In both the 60 patients receiving Lambda and 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39). Both Lambda and placebo were well-tolerated, though liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.

  View details for DOI 10.1038/s41467-021-22177-1

  View details for PubMedID 33785743

• Design of a population-based longitudinal cohort study of SARS-CoV-2 incidence and prevalence among adults in the San Francisco Bay Area. Annals of epidemiology Lindan, C. P., Desai, M., Boothroyd, D., Judson, T., Bollyky, J., Sample, H., Weng, Y., Cheng, Y., Dahlen, A., Hedlin, H., Grumbach, K., Henne, J., Garcia, S., Gonzales, R., Craik, C. S., Maldonado, Y., Rutherford, G. 2021

  Abstract

  We describe the design of a longitudinal cohort study to determine SARS-CoV-2 incidence and prevalence among a population-based sample of adults living in six San Francisco Bay Area counties.Using an address-based sample, we stratified households by county and by census-tract risk. Risk strata were determined by using regression models to predict infections by geographic area using census-level sociodemographic and health characteristics. We disproportionately sampled high and medium risk strata, which had smaller population sizes, to improve precision of estimates, and calculated a desired sample size of 3400. Participants were primarily recruited by mail and were followed monthly with PCR testing of nasopharyngeal swabs, testing of venous blood samples for antibodies to SARS-CoV-2 spike and nucleocapsid antigens, and testing of the presence of neutralizing antibodies, with completion of questionnaires about socio-demographics and behavior. Estimates of incidence and prevalence will be weighted by county, risk strata and sociodemographic characteristics of non-responders, and will take into account laboratory test performance.We enrolled 3842 adults from August to December, 2020, and completed follow-up March 31, 2021. We reached target sample sizes within most strata.Our stratified random sampling design will allow us to recruit a robust general population cohort of adults to determine the incidence of SARS-CoV-2 infection. Identifying risk strata was unique to the design and will help ensure precise estimates, and high-performance testing for presence of virus and antibodies will enable accurate ascertainment of infections.

  View details for DOI 10.1016/j.annepidem.2021.11.001

  View details for PubMedID 34800659

• SARS-CoV-2 subgenomic RNA kinetics in longitudinal clinical samples Open Forum Infectious Diseases Verma, R., Kim, E., Martinez, G., Jagannathan, ., Rustagi, A., Parsonnet, J., Bonilla, H., Khosla, C., Holubar, M., Subramanian, A., Singh, ., Maldonado, Y., Blish, C., Andrews, J. 2021

  View details for DOI 10.1093/ofid/ofab310

• Prospective Pilot Study Evaluating SARS-CoV-2 Transmission-Limiting Measures in an On-Site School. Academic pediatrics Jani, S. G., Ma, J., Pulendran, U., Hsing, J. C., Altamirano, J., Shah, S., Toomarian, E. Y., Maldonado, Y., Wang, C. J. 2021

  Abstract

  The purpose of our study is to evaluate the feasibility and reliability of a comprehensive set of preventive measures in limiting secondary transmission of COVID-19 in schools.A prospective cohort study was conducted to evaluate SARS-CoV-2 transmission in an independent K-8 school in San Mateo County, California. The research was conducted between September 14, 2020 through March 22, 2021 and consisted of: (1) demographic and epidemiological questionnaires; (2) daily symptom reporting; (3) weekly RT-PCR testing; and (4) periodic on-site qualitative observations.180 (79%) students and 63 (74%) on-site staff/contractors were enrolled. Participants reported symptoms in 144 (<1%) daily surveys of the 19,409 collected. Among those who reported symptoms and exposures, none tested positive during the 22-week study period. Of all participants, a total of 6 tested positive for SARS-CoV-2 at least once by RT-PCR; all were asymptomatic at time of testing. No in-school transmission occurred. Mask adherence was high among all grades, and incidents of improper mask use mostly occurred during non-instruction time. Physical distancing was well-enforced during class time and snack breaks, although adherence during non-instruction time waned as the school year progressed.Our comprehensive, prospective study following COVID-19 transmission over 22 weeks in a K-8 school demonstrates that: (1) surveillance testing is important for detecting asymptomatic infections in schools; (2) monitoring symptoms may not be necessary and/or sufficient for COVID-19; and (3) younger children can adhere to key mitigation measures (e.g., masking) which have the potential to limit transmission.

  View details for DOI 10.1016/j.acap.2021.11.019

  View details for PubMedID 34896273

• SARS-CoV-2 Seroprevalence in Healthcare Personnel in Northern California Early in the COVID-19 Pandemic. Infection control and hospital epidemiology Rosser, J. I., Roltgen, K., Dymock, M., Shepard, J., Martin, A., Hogan, C. A., Blomkalns, A., Mathew, R., Parsonnet, J., Pinsky, B. A., Maldonado, Y. A., Boyd, S. D., Chang, S., Holubar, M., Stanford Healthcare COVID-19 Workforce Response Group 2020: 1–27

  Abstract

  OBJECTIVE: We aimed to assess the magnitude of unidentified SARS-CoV-2 infections in our healthcare personnel (HCP) early in the COVID-19 pandemic and evaluate risk factors for infection in order to identify areas for infection control practice improvement in a northern California academic medical center.METHODS: We reviewed the anti-SARS-CoV-2 receptor binding domain (RBD) IgG serologic test results and self-reported risk factors for seropositivity among 10,449 asymptomatic HCP who underwent voluntary serology testing between April 20 and May 20, 2020.RESULTS: In total, 136 employees (1.3%) tested positive for SARS-CoV-2 IgG. This included 41 (30.1%) individuals who had previously tested positive for SARS-CoV-2 by nasopharyngeal reverse transcription polymerase chain reaction (RT-PCR) between March 13 and April 16, 2020. In multivariable analysis, employees of Hispanic ethnicity (OR = 2.01; 95% CI = 1.22-3.46) and those working in environmental services/food services/patient transport (OR = 4.81; 95% CI = 2.08-10.30) were at increased risk for seropositivity compared to other groups. Employees reporting a household contact with COVID-19 were also at higher risk for seropositivity (OR = 3.25; 95% CI = 1.47-6.44), but those with a work exposure were not (OR = 1.27; 95% CI = 0.58-2.47). Importantly, one-third of seropositive individuals reported no prior symptoms, no suspected exposures, and no prior positive RT-PCR test.CONCLUSION: In this study, SARS-CoV-2 seropositivity among HCP early in the northern California epidemic appeared to be quite low and was more likely attributable to community rather than occupational exposure.

  View details for DOI 10.1017/ice.2020.1358

  View details for PubMedID 33292895

• Metagenomic sequencing of stool samples in Bangladeshi infants: virome association with poliovirus shedding after oral poliovirus vaccination. Scientific reports Tan, S. K., Granados, A. C., Bouquet, J., Hoy-Schulz, Y. E., Green, L., Federman, S., Stryke, D., Haggerty, T. D., Ley, C., Yeh, M., Jannat, K., Maldonado, Y. A., Andino, R., Parsonnet, J., Chiu, C. Y. 2020; 10 (1): 15392

  Abstract

  The potential role of enteric viral infections and the developing infant virome in affecting immune responses to the oral poliovirus vaccine (OPV) is unknown. Here we performed viral metagenomic sequencing on 3 serially collected stool samples from 30 Bangladeshi infants following OPV vaccination and compared findings to stool samples from 16 age-matched infants in the United States (US). In 14 Bangladeshi infants, available post-vaccination serum samples were tested for polio-neutralizing antibodies. The abundance (p=0.006) and richness (p=0.013) of the eukaryotic virome increased with age and were higher than seen in age-matched US infants (p<0.001). In contrast, phage diversity metrics remained stable and were similar to those in US infants. Non-poliovirus eukaryotic virus abundance (3.68 log10 vs. 2.25 log10, p=0.002), particularly from potential viral pathogens (2.78log10 vs. 0.83log10, p=0.002), and richness (p=0.016) were inversely associated with poliovirus shedding. Following vaccination, 28.6% of 14 infants tested developed neutralizing antibodies to all three Sabin types and also exhibited higher rates of poliovirus shedding (p=0.020). No vaccine-derived poliovirus variants were detected. These results reveal an inverse association between eukaryotic virome abundance and poliovirus shedding. Overall gut virome ecology and concurrent viral infections may impact oral vaccine responsiveness in Bangladeshi infants.

  View details for DOI 10.1038/s41598-020-71791-4

  View details for PubMedID 32958861

• Rank Equity Index: Measuring Parity in the Advancement of Underrepresented Populations in Academic Medicine. Academic medicine : journal of the Association of American Medical Colleges Fassiotto, M., Flores, B., Victor, R., Altamirano, J., Garcia, L. C., Kotadia, S., Maldonado, Y. 2020

  Abstract

  As educators, researchers, clinicians, and administrators, faculty serve pivotal roles in academic medical centers (AMCs). Thus, the quality of faculty members' experiences is inseparable from an AMC's success. In seeking new methods to assess equity in advancement in academic medicine, the authors developed the Rank Equity Index (REI)-adapted from the Executive Parity Index, a scale previously implemented within the business sector-to examine national data on gender and racial/ethnic equity across faculty ranks. The REI was employed on self-reported demographic data, collected by the Association of American Medical Colleges, from U.S. medical school faculty in 2017, to make pairwise rank comparisons of the professoriate by demographic characteristics and department. Overall results indicated that women did not attain parity at any pairwise rank comparison, while men were above parity at all ranks. Similar results were observed across all departments surveyed: women in the basic sciences had REIs closest to parity, women in pediatrics had the highest representation but had REIs that were further from parity than the REIs in the basic sciences, and women in surgery demonstrated the lowest REIs. Nationally, REIs were below 1.00 for all racial/ethnic group rank comparisons except for White and, in one case, multiple race non-Hispanic/Latinx. Across all analyzed departments, Black/African American, Asian, Hispanic/Latinx, and multiple race Hispanic/Latinx faculty had REIs below parity at all ranks except in two cases. In a comparison of 2017 and 2007 data, REIs across both race/ethnicity and gender were lower in 2007 for nearly all groups. REI analyses can highlight inequities in faculty rank that may be masked when using aggregate faculty proportions, which do not account for rank. The REI provides AMCs with a new tool to better analyze institutional data to inform efforts to increase parity across all faculty ranks.

  View details for DOI 10.1097/ACM.0000000000003720

  View details for PubMedID 32889948

• The Long "Race" to Diversity in Otolaryngology. Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery Tusty, M., Flores, B., Victor, R., Fassiotto, M., Maldonado, Y., Howard, J., Valdez, T. A. 2020: 194599820951132

  Abstract

  The number of health disparities disproportionately affecting minority communities continue to rise. Thus, it is imperative to assess whether equity within medical school enrollment and along the academic pipeline has mirrored this growth, especially among elite surgical specialties such as otolaryngology. Census and educational data from 2010 and 2018 were used to assess the current otolaryngology, surgery, and internal medicine physician and faculty workforce diversity across each stage of the academic medicine trajectory by race and ethnicity. We found that disparities exist in medical school enrollment for minority students such that Hispanic/Latinx representation was only 30% and Black representation only 50% of their respective proportions in the US population in 2018. Disparities in achieving full professorship were also observed across all 3 specialties but most prominently in otolaryngology, with 1% Black representation among otolaryngology professors in 2018. A collective strategy toward diversifying the otolaryngology workforce should be explored.

  View details for DOI 10.1177/0194599820951132

  View details for PubMedID 32838654

• Asymptomatic SARS-CoV-2 Transmission from Community Contacts in Healthcare Workers. Annals of surgery Graham, L. A., Maldonado, Y. A., Tompkins, L. S., Wald, S. H., Chawla, A., Hawn, M. T. 2020

  View details for DOI 10.1097/SLA.0000000000003968

  View details for PubMedID 32487801

• Vaccination Policies and Disease Incidence Across the Pond: Implications for the United States. Pediatrics O'Leary, S. T., Maldonado, Y. A. 2020

  View details for DOI 10.1542/peds.2019-2436

  View details for PubMedID 31932360

• Kinetics of SARS-CoV-2 positivity of infected and recovered patients from a single center. Scientific reports Huang, J. n., Zheng, L. n., Li, Z. n., Hao, S. n., Ye, F. n., Chen, J. n., Gans, H. A., Yao, X. n., Liao, J. n., Wang, S. n., Zeng, M. n., Qiu, L. n., Li, C. n., Whitin, J. C., Tian, L. n., Chubb, H. n., Hwa, K. Y., Ceresnak, S. R., Zhang, W. n., Lu, Y. n., Maldonado, Y. A., McElhinney, D. B., Sylvester, K. G., Cohen, H. J., Liu, L. n., Ling, X. B. 2020; 10 (1): 18629

  Abstract

  Recurrence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive detection in infected but recovered individuals has been reported. Patients who have recovered from coronavirus disease 2019 (COVID-19) could profoundly impact the health care system. We sought to define the kinetics and relevance of PCR-positive recurrence during recovery from acute COVID-19 to better understand risks for prolonged infectivity and reinfection. A series of 414 patients with confirmed SARS-Cov-2 infection, at The Second Affiliated Hospital of Southern University of Science and Technology in Shenzhen, China from January 11 to April 23, 2020. Statistical analyses were performed of the clinical, laboratory, radiologic image, medical treatment, and clinical course of admission/quarantine/readmission data, and a recurrence predictive algorithm was developed. 16.7% recovered patients with PCR positive recurring one to three times, despite being in strict quarantine. Younger patients with mild pulmonary respiratory syndrome had higher risk of PCR positivity recurrence. The recurrence prediction model had an area under the ROC curve of 0.786. This case series provides characteristics of patients with recurrent SARS-CoV-2 positivity. Use of a prediction algorithm may identify patients at high risk of recurrent SARS-CoV-2 positivity and help to establish protocols for health policy.

  View details for DOI 10.1038/s41598-020-75629-x

  View details for PubMedID 33122706

• Update from the Advisory Committee on Immunization Practices. Journal of the Pediatric Infectious Diseases Society O'Leary, S. T., Maldonado, Y. n., Kimberlin, D. W. 2020

  Abstract

  The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, normally meets 3 times per year to develop recommendations for vaccine use in the U.S. Because of the SARS-CoV-2 pandemic, there are several SARS-CoV-2 vaccines currently in late stage clinical trials, so the ACIP is now meeting monthly for single day meetings, with plans to continue standard 2-3 day meetings as per usual (February, June, and October). Emergency meetings of ACIP may occur if a vaccine candidate receives an Emergency Use Authorization (EUA) from the FDA. This Update provides a combined summary of the August 26 and September 22, 2020, meetings, both of which focused completely on COVID-19 vaccines. Representatives from the American Academy of Pediatrics (YAM, DWK) and the Pediatric Infectious Diseases Society (STO) are present as liaisons to the ACIP.

  View details for DOI 10.1093/jpids/piaa144

  View details for PubMedID 33180938

• Maternal HBV Viremia and Association With Adverse Infant Outcomes in Women Living With HIV and HBV. The Pediatric infectious disease journal Bhattacharya, D. n., Guo, R. n., Tseng, C. H., Emel, L. n., Sun, R. n., Chiu, S. H., Stranix-Chibanda, L. n., Chipato, T. n., Mohtashemi, N. Z., Kintu, K. n., Manji, K. P., Moodley, D. n., Thio, C. L., Maldonado, Y. n., Currier, J. S. 2020

  Abstract

  There is limited information on perinatal outcomes in HIV-hepatitis B virus (HBV) coinfection.HIV Prevention Trials Network (HPTN) 046 was a randomized double-blind placebo-controlled trial of perinatal transmission that evaluated 6 months of infant nevirapine versus placebo among breast-fed infants. Women living with HIV and their infants enrolled in sub-Saharan Africa from 2007 to 2010; 78% received antiretroviral therapy (ART). Maternal samples were tested for hepatitis B surface antigen (HBsAg). High and low HBV viral load (VL) was defined as ≥10 IU/mL and <10 IU/mL. The association between HIV-HBV coinfection and maternal and infant outcomes was assessed using multivariate (MV) logistic and Cox regression.Among 2025 women, 88 (4.3%) had HBV. HIV-HBV women with high HBV VL had lower median CD4, versus HIV alone or HIV-HBV women with low HBV VL [320, 490 and 434 cells/mm, respectively (P < 0.007)]. In MV analysis, adjusted for maternal CD4, age and maternal ART, infants born to women with high HBV VL were more likely to be low birth weight (LBW), versus HIV+/HBV- and low HBV VL women: [30% (3/10) vs. 10% (194/1953) vs. 6% (5/78), respectively, P = 0.03). High HBV VL was associated with HIV perinatal transmission [(hazard ratio 6.75 (95% confidence interval (CI): 1.86 - 24.50)]. There was no impact on infant mortality or maternal outcomes at 18 months.In HIV-HBV women, high HBV viral loads increase the risk of LBW and potentially HIV perinatal transmission. Reduction of antepartum HBV viremia may have beneficial effects beyond the prevention of HBV perinatal transmission.

  View details for DOI 10.1097/INF.0000000000002980

  View details for PubMedID 33181788

• Everyday Heroism: Maintaining Organizational Cultures of Wellness and Inclusive Excellence Amid Simultaneous Pandemics. Academic medicine : journal of the Association of American Medical Colleges Fassiotto, M. n., Valantine, H. n., Shanafelt, T. n., Maldonado, Y. n. 2020; Publish Ahead of Print

  Abstract

  Health care professionals and the institutions in which they work are being stretched to their limits amidst the current COVID-19 pandemic. At the same time, a second longstanding pandemic has been brought to the fore: the entrenched system of racial injustice and oppression. The first pandemic is new and to date substantial resources have been allocated to urgently addressing its mitigation; the second has a long history with inconsistent attention and resources but has recently been spotlighted more intensely than at any time in the nation's recent past. The authors of this article contend that these 2 simultaneous pandemics have brought forth the need for institutions in the United States to make a renewed commitment to respect, wellness, diversity, and inclusion. While investment and leadership in these domains have always been essential, these have largely been viewed as a "nice-to-have" option. The events of much of 2020 (most notably) have illustrated that committing to and investing in policies, programs, centers, and leadership to drive change in these domains are essential and a "need-to-have" measure. The authors outline the necessity of investing in the promotion of cultures of inclusive excellence at both individual and organizational levels to coordinate a united response to the simultaneous pandemics. It is in the interests of health care systems to consider the wellness of the workforce to overcome the longer term economic, systemic, and social trauma that will likely occur for years to come at both the individual and institutional levels. Maintaining or augmenting investment is necessary despite the economic challenges the nation faces. Now is the time to cultivate resilience and wellness through a renewed commitment to cultures of respect, diversity, and inclusion. This commitment is urgently needed to support and sustain the health care workforce and maintain outstanding health care systems for future generations.

  View details for DOI 10.1097/ACM.0000000000003905

  View details for PubMedID 33369903

• Update from the Advisory Committee on Immunization Practices. Journal of the Pediatric Infectious Diseases Society O'Leary, S. T., Maldonado, Y. A., Kimberlin, D. W. 2020

  Abstract

  The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use in the United States. There are usually 15 voting members; members' terms are for 4 years. ACIP members and Centers for Disease Control and Prevention staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and results from clinical trials. Representatives from the American Academy of Pediatrics (Y. A. M., D. W. K.) and the Pediatric Infectious Diseases Society (S. T. O.) are present as liaisons to the ACIP. The ACIP met on 23-24 October 2019 to discuss pertussis vaccines, the child/adolescent and adult immunization schedule, influenza vaccine effectiveness and safety, Ebola vaccine, orthopoxvirus vaccines, Dengue vaccine, rabies vaccine, measles, and vaccine safety update.

  View details for DOI 10.1093/jpids/piaa008

  View details for PubMedID 32016424

• Burnout, Depression, Career Satisfaction, and Work-Life Integration by Physician Race/Ethnicity. JAMA network open Garcia, L. C., Shanafelt, T. D., West, C. P., Sinsky, C. A., Trockel, M. T., Nedelec, L. n., Maldonado, Y. A., Tutty, M. n., Dyrbye, L. N., Fassiotto, M. n. 2020; 3 (8): e2012762

  Abstract

  Previous research suggests that the prevalence of occupational burnout varies by demographic characteristics, such as sex and age, but the association between physician race/ethnicity and occupational burnout is less well understood.To investigate possible differences in occupational burnout, depressive symptoms, career satisfaction, and work-life integration by race/ethnicity in a sample of US physicians.In this cross-sectional study, data for this secondary analysis of 4424 physicians were originally collected from a cross-sectional survey of US physicians between October 12, 2017, and March 15, 2018. The dates of analysis were March 8, 2019, to May 21, 2020. Multivariable logistic regression, including statistical adjustment for physician demographic and clinical practice characteristics, was performed to examine the association between physician race/ethnicity and occupational burnout, depressive symptoms, career satisfaction, and work-life integration.Physician demographic and clinical practice characteristics included race/ethnicity, sex, age, clinical specialty, hours worked per week, primary practice setting, and relationship status.Physicians with a high score on the emotional exhaustion or depersonalization subscale of the Maslach Burnout Inventory were classified as having burnout. Depressive symptoms were measured using the Primary Care Evaluation of Mental Disorders instrument. Physicians who marked "strongly agree" or "agree" in response to the survey items "I would choose to become a physician again" and "My work schedule leaves me enough time for my personal/family life" were considered to be satisfied with their career and work-life integration, respectively.Data were available for 4424 physicians (mean [SD] age, 52.46 [12.03] years; 61.5% [2722 of 4424] male). Most physicians (78.7% [3480 of 4424]) were non-Hispanic White. Non-Hispanic Asian, Hispanic/Latinx, and non-Hispanic Black physicians comprised 12.3% (542 of 4424), 6.3% (278 of 4424), and 2.8% (124 of 4424) of the sample, respectively. Burnout was observed in 44.7% (1540 of 3447) of non-Hispanic White physicians, 41.7% (225 of 540) of non-Hispanic Asian physicians, 38.5% (47 of 122) of non-Hispanic Black physicians, and 37.4% (104 of 278) of Hispanic/Latinx physicians. The adjusted odds of burnout were lower in non-Hispanic Asian physicians (odds ratio [OR], 0.77; 95% CI, 0.61-0.96), Hispanic/Latinx physicians (OR, 0.63; 95% CI, 0.47-0.86), and non-Hispanic Black physicians (OR, 0.49; 95% CI, 0.30-0.79) compared with non-Hispanic White physicians. Non-Hispanic Black physicians were more likely to report satisfaction with work-life integration compared with non-Hispanic White physicians (OR, 1.69; 95% CI, 1.05-2.73). No differences in depressive symptoms or career satisfaction were observed by race/ethnicity.Physicians in minority racial/ethnic groups were less likely to report burnout compared with non-Hispanic White physicians. Future research is necessary to confirm these results, investigate factors contributing to increased rates of burnout among non-Hispanic White physicians, and assess factors underlying the observed patterns in measures of physician wellness by race/ethnicity.

  View details for DOI 10.1001/jamanetworkopen.2020.12762

  View details for PubMedID 32766802

• Patient Age, Race and Emergency Department Treatment Area Associated with "Topbox" Press Ganey Scores. The western journal of emergency medicine Lee, M. O., Altamirano, J. n., Garcia, L. C., Gisondi, M. A., Wang, N. E., Lippert, S. n., Maldonado, Y. n., Gharahbaghian, L. n., Ribeira, R. n., Fassiotto, M. n. 2020; 21 (6): 117–24

  Abstract

  Hospitals commonly use Press Ganey (PG) patient satisfaction surveys for benchmarking physician performance. PG scores range from 1 to 5, with 5 being the highest, which is known as the "topbox" score. Our objective was to identify patient and physician factors associated with topbox PG scores in the emergency department (ED).We looked at PG surveys from January 2015-December 2017 at an academic, urban hospital with 78,000 ED visits each year. Outcomes were topbox scores for the questions: "Likelihood of your recommending our ED to others"; and "Courtesy of the doctor." We analyzed topbox scores using generalized estimating equation models clustered by physician and adjusted for patient and physician factors. Patient factors included age, gender, race, ethnicity, and ED area where patient was seen. The ED has four areas based on patient acuity: emergent; urgent; vertical (urgent but able to sit in a recliner rather than a gurney); and fast track (non-urgent). Physician factors included age, gender, race, ethnicity, and number of years at current institution.We analyzed a total of 3,038 surveys. For "Likelihood of your recommending our ED to others," topbox scores were more likely with increasing patient age (odds ratio [OR] 1.07; 95% confidence interval [CI], 1.03-1.12); less likely among female compared to male patients (OR 0.81; 95% CI, 0.70-0.93); less likely among Asian compared to White patients (OR 0.71; 95% CI, 0.60-0.83); and less likely in the urgent (OR 0.71; 95% CI, 0.54-0.93) and vertical areas (OR 0.71; 95% CI 0.53-0.95) compared to fast track. For "Courtesy of the doctor," topbox scores were more likely with increasing patient age (OR 1.1; CI, 1.06-1.14); less likely among Asian (OR 0.70; 95% CI, 0.58-0.84), Black (OR 0.66; 95% CI, 0.45-0.96), and Hispanic patients (OR 0.68; 95% CI, 0.55-0.83) compared to White patients; and less likely in urgent area (OR 0.69; 95% CI, 0.50-0.95) compared to fast track.Increasing patient age was associated with increased likelihood of topbox scores, while Asian patients, and urgent and vertical areas had decreased likelihood of topbox scores. We encourage hospitals that use PG topbox scores as financial incentives to understand the contribution of non-service factors to these scores.

  View details for DOI 10.5811/westjem.2020.8.47277

  View details for PubMedID 33207156

• Assessment of Sensitivity and Specificity of Patient-Collected Lower Nasal Specimens for Sudden Acute Respiratory Syndrome Coronavirus 2 Testing. JAMA network open Altamirano, J. n., Govindarajan, P. n., Blomkalns, A. L., Kushner, L. E., Stevens, B. A., Pinsky, B. A., Maldonado, Y. n. 2020; 3 (6): e2012005

  View details for DOI 10.1001/jamanetworkopen.2020.12005

  View details for PubMedID 32530469

• The 2016 California policy to eliminate nonmedical vaccine exemptions and changes in vaccine coverage: An empirical policy analysis PLOS MEDICINE Nyathi, S., Karpel, H. C., Sainani, K. L., Maldonado, Y., Hotez, P. J., Bendavid, E., Lo, N. C. 2019; 16 (12)

  View details for DOI 10.1371/journal.pmed.1002994.r005

  View details for Web of Science ID 000507280500007

• Congenital microcephaly hospitalizations in California infants: 1999-2013. Birth defects research Krasnow, M. R., Maldonado, Y. A., Contopoulos-Ioannidis, D. G. 2019

  Abstract

  INTRODUCTION: Population-level changes in microcephaly incidence risk (IR) could signal circulation of neurotropic pathogens or potential emerging teratogen exposure.METHODS: In this retrospective population cohort study, we estimated the IR of hospitalizations with a microcephaly ICD-9-CM discharge diagnosis code among infants ≤1 year over a 15-year period (1999-2013) using the Electronic Health Record (EHR) database from all hospital discharges in California from the Office of Statewide Hospital Planning and Development (OSHPD) database. We calculated the overall and yearly IRs per 10,000 live births (LBs) and per 10,000 hospitalizations in infants ≤1 year, and explored the impact in the IR estimates when children with microcephaly associated comorbidities were excluded or not.RESULTS: Among 8,860,153 hospital discharges of infants ≤1 year in the OSHPD database over this 15year period, we identified 6,004 hospitalizations with a microcephaly discharge diagnosis code; 3,526 of those were in neonates ≤30days. The IR of microcephaly hospitalizations for infants ≤1 year was 7.70/10,000 LB (for neonates it was 4.52/10,000 LB) and 6.78 per 10,000 hospitalizations ≤1 year. There was large heterogeneity in the yearly microcephaly IRs (I2 =66.6%).DISCUSSION: EHR collected data could be used as a complementary approach to track epidemiologic changes in microcephaly IRs. However, standardization in the use of microcephaly discharge diagnosis code and harmonization in the types of additional comorbidities to be excluded across analyses is mandatory to allow for prompt identification of true changes in microcephaly rates over time.

  View details for DOI 10.1002/bdr2.1604

  View details for PubMedID 31639287

• Acute Toxoplasma infection in pregnant women worldwide: Asystematic review and meta-analysis. PLoS neglected tropical diseases Rostami, A., Riahi, S. M., Contopoulos-Ioannidis, D. G., Gamble, H. R., Fakhri, Y., Shiadeh, M. N., Foroutan, M., Behniafar, H., Taghipour, A., Maldonado, Y. A., Mokdad, A. H., Gasser, R. B. 2019; 13 (10): e0007807

  Abstract

  BACKGROUND: Acute Toxoplasma infection (ATI) during pregnancy, if left untreated, can cause severe adverse outcomes for the fetus and newborn. Here, we undertook a meta-analysis to estimate the worldwide prevalence of ATI in pregnant women.METHODS: We searched international databases for studies published between January 1988 and November 2018. We included population-based cross-sectional and prospective cohort studies that reported the prevalence of ATI in pregnant women. Data were synthesized using a random effect model to calculate the overall prevalence of ATI (with a 95% CI) in six WHO regions and globally. We also performed linear meta-regression analyses to investigate associations of maternal, socio-demographic, geographical and climate parameters with the prevalence of ATI.RESULTS: In total, 217 studies comprising 902,228 pregnant women across 74 countries were included in the meta-analysis. The overall prevalence of ATI in pregnant women globally was 1.1% (95% CI: 0.9-1.2%). In studies where more strict criteria for ATI were used, the overall prevalence was 0.6% (95% CI: 0.4-0.7%). The prevalence was highest in the Eastern Mediterranean region (2.5%; 95%CI: 1.7-3.4%) and lowest in the European region (0.5%; 95% CI: 0.4-0.7%). A significantly higher prevalence of ATI was found in countries with lower income levels (P = 0.027), lower human development indices (P = 0.04), higher temperatures (P = 0.02) and lower latitudes (P = 0.005) and longitudes (P = 0.02).CONCLUSIONS: The risk of acquiring ATI during gestation is clinically important and preventive measures to avoid exposure of pregnant women to Toxoplasma infection should be strictly applied.

  View details for DOI 10.1371/journal.pntd.0007807

  View details for PubMedID 31609966

• Update From the Advisory Committee on Immunization Practices. Journal of the Pediatric Infectious Diseases Society O'leary, S. T., Maldonado, Y. A., Kimberlin, D. W. 2019

  Abstract

  The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use in the United States. There usually are 15 voting members, but at the June 2019 meeting, only 14 were present; each member's term is 4 years. ACIP members and Centers for Disease Control and Prevention (CDC) staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and clinical trial results. Representatives from the American Academy of Pediatrics (AAP) (Y. A. M. and D. W. K.) and the Pediatric Infectious Diseases Society (S. T. O.) are present as liaisons to the ACIP. The ACIP met on June 26 to 27, 2019, to discuss the use of human papillomavirus (HPV) vaccine in adults, pneumococcal vaccines in adults, measles updates, zoster vaccine, influenza vaccines, hepatitis A virus (HAV) vaccines, meningococcal vaccines, and dengue vaccine.

  View details for DOI 10.1093/jpids/piz058

  View details for PubMedID 31589289

• Achieving Speaker Gender Equity at the SIR Annual Scientific Meeting: The Effect of Female Session Coordinators. Journal of vascular and interventional radiology : JVIR Ghatan, C. E., Altamirano, J., Fassiotto, M., Perez, M. G., Maldonado, Y., Josephs, S., Sze, D. Y., Kothary, N. 2019

  Abstract

  PURPOSE: To examine the impact of targeted efforts to increase the number of female speakers at the Society of Interventional Radiology (SIR) Annual Scientific Meeting (ASM) by reporting gender trends for invited faculty in 2017/2018 vs2016.MATERIALS AND METHODS: Faculty rosters for the 2016, 2017, and 2018 SIR ASMs were stratified by gender to quantify female representation at plenary sessions, categorical courses, symposia, self-assessment modules, and "meet-the-expert" sessions. Keynote events, scientific abstract presentations, and award ceremonies were excluded. In 2017, the SIR Annual Meeting Committee issued requirements for coordinators to invite selected women as speakers. Session coordinators are responsible for issuing speaker invitations, and invited speakers have the option to decline.RESULTS: Years 2017 and 2018 showed increases in female speaker representation, with women delivering 13% (89 of 687) and 14% (85 of 605) of all assigned presentations, compared with 9% in 2016 (46 of 514; P= .03 and P= .01, respectively). Gender diversity correlated with the gender of the session coordinator(s). When averaged over a 3-year period, female speakers constituted 7% of the speaker roster (112 of 1,504 presentations) for sessions led by an all-male coordinator team, compared with 36% (108 of 302) for sessions led by at least 1 female coordinator (P < .0001). Results of the linear regression model confirmed the effect of coordinator team gender composition (P < .0001).CONCLUSIONS: Having a woman as a session coordinator increased female speaker participation, which suggests that the inclusion of more women as coordinators is one mechanism for achieving gender balance at scientific meetings.

  View details for DOI 10.1016/j.jvir.2019.07.006

  View details for PubMedID 31587951

• Update From the Advisory Committee on Immunization Practices. Journal of the Pediatric Infectious Diseases Society O'Leary, S. T., Maldonado, Y. A., Kimberlin, D. W. 2019

  Abstract

  The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use in the United States. The group usually has 15 voting members, each of whom is appointed to a 4-year term. ACIP members and Centers for Disease Control and Prevention staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and clinical trial results. Representatives from the American Academy of Pediatrics (Y. A. M. and D. W. K.) and the Pediatric Infectious Diseases Society (S. T. O.) are present as liaisons to the ACIP. The ACIP met February 27 to 28, 2019, to discuss hepatitis A (HepA) vaccination of human immunodeficiency virus-infected persons, pneumococcal vaccination among adults aged 65 years or older, influenza vaccine effectiveness and safety, anthrax vaccination in the setting of a mass exposure, human papillomavirus vaccine, zoster vaccines, and Japanese encephalitis vaccine.

  View details for DOI 10.1093/jpids/piz045

  View details for PubMedID 31367738

• Risk Factors of Ambulatory Central Line-Associated Bloodstream Infection in Pediatric Short Bowel Syndrome. JPEN. Journal of parenteral and enteral nutrition Seddik, T. B., Tian, L., Nespor, C., Kerner, J., Maldonado, Y., Gans, H. 2019

  Abstract

  BACKGROUND: Children with short bowel syndrome (SBS) receiving home parenteral nutrition (HPN) are predisposed to ambulatory central line-associated bloodstream infection (A-CLABSI). Data describing risk factors of this infection in children are limited.METHODS: Retrospective cohort, single-center, case-crossover study of children ≤18 years old with SBS receiving HPN from January 2012 to December 2016. Univariate and multivariate mixed effect Poisson regression identified the relative risk (RR) of A-CLABSI with proposed risk factors.RESULTS: Thirty-five children were identified; median follow-up was 30 months. A-CLABSI rate was 4.2 per 1000 central line (CL) days. Univariate analysis identified younger age (RR: 0.92 per 12-month increase [95% confidence interval {CI}: 0.85-0.99; P = 0.036]), shorter small intestine length (RR: 0.96 per 10-cm increase [95% CI: 0.92-0.99; P = 0.008]), lower citrulline level (RR: 0.86 per 5-nmol/mL increase [95% CI: 0.75-0.99; P = 0.036]), and recent CL break (RR: 1.55 [95% CI: 1.06-2.28; P = 0.024]) as risk factors for A-CLABSI. Multivariate analysis showed increased A-CLABSI with clinical diagnosis of small intestine bacterial overgrowth (SIBO) (RR: 1.87 [95% CI: 1.1-3.17; P = 0.021]) and CL breaks (RR: 1.49 [95% CI: 1-2.22; P = 0.024]).CONCLUSIONS: Factors influencing gut integrity increase A-CLABSI rate, supporting translocation as an important mechanism and target for prevention. Clinical diagnosis of SIBO increases A-CLABSI rate, but whether dysbiosis or diarrhea is responsible is an area for future research. CL maintenance is crucial, and prevention of breaks would likely decrease A-CLABSI rate.

  View details for DOI 10.1002/jpen.1667

  View details for PubMedID 31179578

• Untapped Resources: Attaining Equitable Representation for Women in IR JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY Perez, M. G., Fassiotto, M., Altamirano, J., Hwang, G. L., Maldonado, Y., Josephs, S., Sze, D. Y., Kothary, N. 2019; 30 (4): 579–83

  View details for DOI 10.1016/j.jvir.2018.10.028

  View details for Web of Science ID 000464772000015

• Untapped Resources: Attaining Equitable Representation for Women in IR. Journal of vascular and interventional radiology : JVIR Perez, M. G., Fassiotto, M., Altamirano, J., Hwang, G. L., Maldonado, Y., Josephs, S., Sze, D. Y., Kothary, N. 2019

  Abstract

  PURPOSE: To investigate the current state of gender diversity among invited coordinators at the Society of Interventional Radiology (SIR) Annual Scientific Meeting and to compare the academic productivity of female interventional radiologists to that of invited male coordinators.MATERIALS AND METHODS: Faculty rosters for the SIR Annual Scientific Meetings from 2015 to 2017 were stratified by gender to quantify female representation among those asked to lead and coordinate podium sessions. To quantify academic productivity and merit, H-index, publications, and authorship by females over a 6-year period (2012-2017) were statistically compared to that of recurring male faculty.RESULTS: From 2015 to 2017, women held 7.1% (9/126), 4.3%, (8/188), and 13.7% (27/197) of the available coordinator positions for podium sessions, with no representation at the plenary sessions, and subject matter expertise was concentrated in economics and education. Academic productivity of the top quartile of published female interventional radiologists was statistically similar to that of the invited male faculty (H-index P= .722; total publications P= .689; and authorship P= .662).CONCLUSIONS: This study found that senior men dominate the SIR Annual Scientific Meeting, with few women leading or coordinating the podium sessions, despite their established academic track record.

  View details for PubMedID 30772166

• Deep sequencing prompts the modification of a real-time RT-PCR for the serotype-specific detection of polioviruses JOURNAL OF VIROLOGICAL METHODS Holubar, M., Sahoo, M. K., Huang, C., Mohamed-Hadley, A., Liu, Y., Waggoner, J. J., Troy, S. B., Garcia-Garcia, L., Ferreyra-Reyes, L., Maldonado, Y., Pinsky, B. A. 2019; 264: 38–43

  View details for DOI 10.1016/j.jviromet.2018.11.007

  View details for Web of Science ID 000456222300006

• The 2016 California policy to eliminate nonmedical vaccine exemptions and changes in vaccine coverage: An empirical policy analysis. PLoS medicine Nyathi, S. n., Karpel, H. C., Sainani, K. L., Maldonado, Y. n., Hotez, P. J., Bendavid, E. n., Lo, N. C. 2019; 16 (12): e1002994

  Abstract

  Vaccine hesitancy, the reluctance or refusal to receive vaccination, is a growing public health problem in the United States and globally. State policies that eliminate nonmedical ("personal belief") exemptions to childhood vaccination requirements are controversial, and their effectiveness to improve vaccination coverage remains unclear given limited rigorous policy analysis. In 2016, a California policy (Senate Bill 277) eliminated nonmedical exemptions from school entry requirements. The objective of this study was to estimate the association between California's 2016 policy and changes in vaccine coverage.We used a quasi-experimental state-level synthetic control analysis and a county-level difference-in-differences analysis to estimate the impact of the 2016 California policy on vaccination coverage and prevalence of exemptions to vaccine requirements (nonmedical and medical). We used publicly available state-level data from the US Centers for Disease Control and Prevention on coverage of measles, mumps, and rubella (MMR) vaccination, nonmedical exemption, and medical exemption in children entering kindergarten. We used county-level data individually requested from state departments of public health on overall vaccine coverage and exemptions. Based on data availability, we included state-level data for 45 states, including California, from 2011 to 2017 and county-level data for 17 states from 2010 to 2017. The prespecified primary study outcome was MMR vaccination in the state analysis and overall vaccine coverage in the county analysis. In the state-level synthetic control analysis, MMR coverage in California increased by 3.3% relative to its synthetic control in the postpolicy period (top 2 of 43 states evaluated in the placebo tests, top 5%), nonmedical exemptions decreased by 2.4% (top 2 of 43 states evaluated in the placebo tests, top 5%), and medical exemptions increased by 0.4% (top 1 of 44 states evaluated in the placebo tests, top 2%). In the county-level analysis, overall vaccination coverage increased by 4.3% (95% confidence interval [CI] 2.9%-5.8%, p < 0.001), nonmedical exemptions decreased by 3.9% (95% CI 2.4%-5.4%, p < 0.001), and medical exemptions increased by 2.4% (95% CI 2.0%-2.9%, p < 0.001). Changes in vaccination coverage across counties after the policy implementation from 2015 to 2017 ranged from -6% to 26%, with larger increases in coverage in counties with lower prepolicy vaccine coverage. Results were robust to alternative model specifications. The limitations of the study were the exclusion of a subset of US states from the analysis and the use of only 2 years of postpolicy data based on data availability.In this study, implementation of the California policy that eliminated nonmedical childhood vaccine exemptions was associated with an estimated increase in vaccination coverage and a reduction in nonmedical exemptions at state and county levels. The observed increase in medical exemptions was offset by the larger reduction in nonmedical exemptions. The largest increases in vaccine coverage were observed in the most "high-risk" counties, meaning those with the lowest prepolicy vaccine coverage. Our findings suggest that government policies removing nonmedical exemptions can be effective at increasing vaccination coverage.

  View details for DOI 10.1371/journal.pmed.1002994

  View details for PubMedID 31869328

• EXTENDED PROPHYLAXIS WITH NEVIRAPINE DOES NOT AFFECT GROWTH IN HIV-EXPOSED INFANTS. Journal of acquired immune deficiency syndromes (1999) Onyango-Makumbi, C. n., Owora, A. H., Mwiru, R. S., Mwatha, A. n., Young, A. M., Moodley, D. n., Coovadia, H. M., Stranix-Chibanda, L. n., Manji, K. n., Maldonado, Y. n., Richardson, P. n., Andrew, P. n., George, K. n., Fawzi, W. n., Fowler, M. G. 2019

  Abstract

  Effects of prolonged nevirapine prophylaxis exposure on growth among HIV-exposed uninfected (HEU) infants are unknown. This study examines the impact of extended nevirapine prophylaxis from 6 weeks to 6 months on the growth of HEU infants followed for 18 months and also identifies correlates of incident wasting, stunting, underweight, and low head circumference in the HPTN 046 trial.Intention-to-treat analysis examined the effect of extended nevirapine exposure on: weight-for-age Z-score (WAZ), length-for-age Z-score (LAZ), weight-for-length Z-score (WLZ) and head circumference-for-age (HCZ). Multivariable linear mixed-effects and Cox proportional hazard models were used to compare growth outcomes between the study arms and identify correlates of incident adverse growth outcomes, respectively.Compared to placebo, extended prophylactic nevirapine given daily from 6 weeks to 6 months did not affect growth in HEU breastfeeding (BF) infants over time (treatment x time: p>.05). However, overall growth declined over time (time effect: p<.01) when compared to WHO general population norms. Male sex was associated with higher risk of all adverse growth outcomes (p<.05), while short BF duration was associated with wasting (p=.03). Maternal ART exposure was protective against underweight (p=.02). Zimbabwe tended to have worse growth outcomes especially stunting, compared to South Africa, Uganda and Tanzania (p<.05).It is reassuring that prolonged exposure to nevirapine for prevention-of- maternal-to-child HIV transmission does not restrict growth. However, targeted interventions are needed to improve growth outcomes among at-risk HEU infants (i.e. male sex, short BF duration, lack of maternal ART exposure, and resident in Zimbabwe).

  View details for DOI 10.1097/QAI.0000000000002145

  View details for PubMedID 31567725

• The Impact of Unconscious Bias in Healthcare: How to Recognize and Mitigate It. The Journal of infectious diseases Marcelin, J. R., Siraj, D. S., Victor, R. n., Kotadia, S. n., Maldonado, Y. A. 2019; 220 (Supplement_2): S62–S73

  Abstract

  The increasing diversity in the US population is reflected in the patients who healthcare professionals treat. Unfortunately, this diversity is not always represented by the demographic characteristics of healthcare professionals themselves. Patients from underrepresented groups in the United States can experience the effects of unintentional cognitive (unconscious) biases that derive from cultural stereotypes in ways that perpetuate health inequities. Unconscious bias can also affect healthcare professionals in many ways, including patient-clinician interactions, hiring and promotion, and their own interprofessional interactions. The strategies described in this article can help us recognize and mitigate unconscious bias and can help create an equitable environment in healthcare, including the field of infectious diseases.

  View details for DOI 10.1093/infdis/jiz214

  View details for PubMedID 31430386

• Management of Neonates Born at >= 35 0/7 Weeks' Gestation With Suspected or Proven Early-Onset Bacterial Sepsis PEDIATRICS Puopolo, K. M., Benitz, W. E., Zaoutis, T. E., Comm Fetus Newborn, Comm Infectious Dis 2018; 142 (6)

  Abstract

  The incidence of neonatal early-onset sepsis (EOS) has declined substantially over the last 2 decades, primarily because of the implementation of evidence-based intrapartum antimicrobial therapy. However, EOS remains a serious and potentially fatal illness. Laboratory tests alone are neither sensitive nor specific enough to guide EOS management decisions. Maternal and infant clinical characteristics can help identify newborn infants who are at risk and guide the administration of empirical antibiotic therapy. The incidence of EOS, the prevalence and implications of established risk factors, the predictive value of commonly used laboratory tests, and the uncertainties in the risk/benefit balance of antibiotic exposures all vary significantly with gestational age at birth. Our purpose in this clinical report is to provide a summary of the current epidemiology of neonatal sepsis among infants born at ≥35 0/7 weeks' gestation and a framework for the development of evidence-based approaches to sepsis risk assessment among these infants.

  View details for DOI 10.1542/peds.2018-2894

  View details for Web of Science ID 000451372200044

  View details for PubMedID 30455342

• Management of Neonates Born at <= 34 6/7 Weeks' Gestation With Suspected or Proven Early-Onset Bacterial Sepsis PEDIATRICS Puopolo, K. M., Benitz, W. E., Zaoutis, T. E., Comm Fetus Newborn, Comm Infectious Dis 2018; 142 (6)

  Abstract

  Early-onset sepsis (EOS) remains a serious and often fatal illness among infants born preterm, particularly among newborn infants of the lowest gestational age. Currently, most preterm infants with very low birth weight are treated empirically with antibiotics for risk of EOS, often for prolonged periods, in the absence of a culture-confirmed infection. Retrospective studies have revealed that antibiotic exposures after birth are associated with multiple subsequent poor outcomes among preterm infants, making the risk/benefit balance of these antibiotic treatments uncertain. Gestational age is the strongest single predictor of EOS, and the majority of preterm births occur in the setting of other factors associated with risk of EOS, making it difficult to apply risk stratification strategies to preterm infants. Laboratory tests alone have a poor predictive value in preterm EOS. Delivery characteristics of extremely preterm infants present an opportunity to identify those with a lower risk of EOS and may inform decisions to initiate or extend antibiotic therapies. Our purpose for this clinical report is to provide a summary of the current epidemiology of preterm neonatal sepsis and provide guidance for the development of evidence-based approaches to sepsis risk assessment among preterm newborn infants.

  View details for DOI 10.1542/peds.2018-2896

  View details for Web of Science ID 000451372200045

  View details for PubMedID 30455344

• Protocol Paper: Oral Poliovirus Vaccine Transmissibility in Communities After Cessation of Routine Oral Poliovirus Vaccine Immunization CLINICAL INFECTIOUS DISEASES Sarnquist, C., Holubar, M., Garcia-Garcia, L., Ferreyra-Reyes, L., Delgado-Sanchez, G., Pablo Cruz-Hervert, L., Montero-Campos, R., Altamirano, J., Purington, N., Boyle, S., Modlin, J., Ferreira-Guerrero, E., Canizales-Quintero, S., Diaz Ortega, J., Desai, M., Maldonado, Y. A. 2018; 67: S115–S120

  View details for DOI 10.1093/cid/ciy606

  View details for Web of Science ID 000450051800016

• Pediatric HIV Infection and Decreased Prevalence of OPV Point Mutations Linked to Vaccine-associated Paralytic Poliomyelitis CLINICAL INFECTIOUS DISEASES Halpern, M. S., Altamirano, J., Maldonado, Y. 2018; 67: S78–S84

  View details for DOI 10.1093/cid/ciy635

  View details for Web of Science ID 000450051800010

• Spatial Analyses of Oral Polio Vaccine Transmission in an Community Vaccinated With Inactivated Polio Vaccine CLINICAL INFECTIOUS DISEASES Jarvis, C., Altamirano, J., Sarnquist, C., Edmunds, W., Maldonado, Y. 2018; 67: S18–S25

  View details for DOI 10.1093/cid/ciy622

  View details for Web of Science ID 000450051800003

• Assessing the Risk of Vaccine-derived Outbreaks After Reintroduction of Oral Poliovirus Vaccine in Postcessation Settings CLINICAL INFECTIOUS DISEASES Fu, R., Altamirano, J., Sarnquist, C. C., Maldonado, Y. A., Andrews, J. R. 2018; 67: S26–S34

  View details for DOI 10.1093/cid/ciy605

  View details for Web of Science ID 000450051800004

• Validation of a High-throughput, Multiplex, Real-time Qualitative Polymerase Chain Reaction Assay for the Detection of Sabin Oral Polio Vaccine in Environmental Samples CLINICAL INFECTIOUS DISEASES Altamirano, J., Leary, S., van Hoorebeke, C., Sarnquist, C., Behl, R., Garcia-Garcia, L., Ferreyra-Reyes, L., Huang, C., Sommer, M., Maldonado, Y. 2018; 67: S98–S102

  View details for DOI 10.1093/cid/ciy639

  View details for Web of Science ID 000450051800013

• OPV Vaccination and Shedding Patterns in Mexican and US Children CLINICAL INFECTIOUS DISEASES Altamirano, J., Sarnquist, C., Behl, R., Garcia-Garcia, L., Ferreyra-Reyes, L., Leary, S., Maldonado, Y. 2018; 67: S85–S89

  View details for DOI 10.1093/cid/ciy636

  View details for Web of Science ID 000450051800011

• Lab Protocol Paper: Use of a High-throughput, Multiplex Reverse-transcription Quantitative Polymerase Chain Reaction Assay for Detection of Sabin Oral Polio Vaccine in Fecal Samples CLINICAL INFECTIOUS DISEASES van Hoorebeke, C., Huang, C., Leary, S., Holubar, M., Altamirano, J., Halpern, M. S., Sommer, M., Maldonado, Y. 2018; 67: S121–S126

  View details for DOI 10.1093/cid/ciy648

  View details for Web of Science ID 000450051800017

• Characterization of Household and Community Shedding and Transmission of Oral Polio Vaccine in Mexican Communities With Varying Vaccination Coverage CLINICAL INFECTIOUS DISEASES Altamirano, J., Purington, N., Behl, R., Sarnquist, C., Holubar, M., Garcia-Garcia, L., Ferreyra-Reyes, L., Montero-Campos, R., Pablo Cruz-Hervert, L., Boyle, S., Modlin, J., van Hoorebeke, C., Leary, S., Huang, C., Sommer, M., Ferreira-Guerrero, E., Delgado-Sanchez, G., Canizales-Quintero, S., Diaz Ortega, J., Desai, M., Maldonado, Y. A. 2018; 67: S4–S17

  View details for DOI 10.1093/cid/ciy650

  View details for Web of Science ID 000450051800002

• Deep Sequencing Prompts the Modification of a Real-time RT-PCR for the Serotype-Specific Detection of Polioviruses. Journal of virological methods Holubar, M., Sahoo, M. K., Huang, C., Mohamed-Hadley, A., Liu, Y., Waggoner, J. J., Troy, S. B., Garcia-Garcia, L., Ferreyra-Reyes, L., Maldonado, Y., Pinsky, B. A. 2018

  Abstract

  Polioviruses are members of the Enterovirus C species and asymptomatic fecal shedding allows for their transmission and persistence in a community, as well as the emergence of vaccine-derived polioviruses. Using three serotype-specific real-time RT-PCR (rRT-PCR) assays, the shedding and circulation of oral poliovirus vaccine (OPV) strains was previously investigated in a prospective cohort of MFexican children, their contacts, and nearby sewage. Subsequently, a deep sequencing approach targeting the P1 genomic region was applied to characterize OPV strains previously detected by rRT-PCR. Amplifiable RNA was obtained for sequencing from 40.3% (58/144) of stool samples and 71.4% (15/21) of sewage using nucleic acids extracted directly from primary rRT-PCR-positive specimens. Sequencing detected one or more OPV serotypes in 62.1% (36/58) of stool and 53.3% (8/15) of sewage samples. All stool and sewage samples in which poliovirus was not detected by deep sequencing contained at least one non-polio enterovirus C (NPEV-C) strain. To improve screening specificity, a modified, two-step, OPV serotype-specific multiplex rRT-PCR was evaluated. In stool specimens, the overall agreement between the original assays and the multiplex was 70.3%. By serotype, the overall agreement was 95.7% for OPV serotype-1 (S1), 65.6% for S2, and 96.1% for S3. Furthermore, most original rRT-PCR positive/multiplex rRT-PCR negative results were collected in the summer and fall months, consistent with NPEV-C circulation patterns. In conclusion, this deep sequencing approach allowed for the characterization of OPV sequences directly from clinical samples and facilitated the implementation of a more specific multiplex rRT-PCR for OPV detection and serotyping.

  View details for PubMedID 30447245

• Protocol Paper: Oral Poliovirus Vaccine Transmissibility in Communities After Cessation of Routine Oral Poliovirus Vaccine Immunization. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Sarnquist, C., Holubar, M., Garcia-Garcia, L., Ferreyra-Reyes, L., Delgado-Sanchez, G., Cruz-Hervert, L. P., Montero-Campos, R., Altamirano, J., Purington, N., Boyle, S., Modlin, J., Ferreira-Guerrero, E., Canizales-Quintero, S., Diaz Ortega, J. L., Desai, M., Maldonado, Y. A. 2018; 67 (suppl_1): S115–S120

  Abstract

  Background: We aimed to elucidate household and community-level shedding and transmission of trivalent oral polio vaccine (tOPV) in communities with inactivated polio vaccine (IPV) routine immunization after tOPV is administered during a national health week (NHW).Methods: We conducted a 3-arm, randomized trial with data collected at baseline through 10 weeks post-NHW in households with at least 1 child <5 years old in 3 semi-rural communities in Orizaba, Mexico. Selected communities were geographically isolated but socio-demographically similar. Each community was assigned an oral polio vaccine (OPV) immunization rate: 10, 30, or 70% of participating households. From 2653 households in the 3 communities, ~150 households per community were selected, for 466 in total. Households were randomized as vaccinated or unvaccinated, with only 1 child under 5 in the vaccinated household receiving OPV during the February 2015 NHW. No other community members received OPV during this NHW. Stool samples were collected up to 10 weeks post-vaccination for all members of the 466 study households and were analyzed for the presence of OPV serotypes using a multiplex polymerase chain reaction assay.Results: We will report on the factors associated with, and incidence and duration of, household and community shedding and transmission of OPV. The secondary outcomes will characterize temporal and geospatial OPV serotype shedding patterns.Conclusions: The current global polio eradication plan relies on transitioning away from OPV to IPV. This study contributes to understanding patterns of OPV shedding and transmission dynamics in communities with primary IPV immunity, in order to optimize the reduction of OPV transmission.

  View details for PubMedID 30376084

• Spatial Analyses of Oral Polio Vaccine Transmission in an Community Vaccinated With Inactivated Polio Vaccine. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Jarvis, C. I., Altamirano, J., Sarnquist, C., Edmunds, W. J., Maldonado, Y. 2018; 67 (suppl_1): S18–S25

  Abstract

  Background: Understanding the spatial dynamics of oral polio vaccine (OPV) transmission will improve resource targeting. Mexico provides a natural laboratory, as it uses inactivated polio vaccine routinely as well as OPV bi-annually.Methods: Using geospatial maps, we measured the distance and density of OPV vaccinees' shedding in the areas nearest to unvaccinated households in 3 Mexican villages. Comparison of transmission to unvaccinated households utilized a mixed effects logistic regression with random effects for household and time, adjusted for age, gender, area, and running water.Results: The median distance from an unvaccinated household to its nearest OPV-shedding household was 85 meters (interquartile range, 46-145) and the median number of vaccinees shedding OPV within 200 m was 3 (2-6). Transmission to unvaccinated households occurred by day 1. There was no association (odds ratio [OR] 1.04; 95% credible interval [CrI] 0.92-1.16) between the distance from OPV shedding and the odds of transmission. The number of OPV vaccinees shedding within 200 m came close to a significant association with unvaccinated transmission (OR 0.93; CrI 0.84-1.01), but this was not the case for households 100 or 500 m apart. Results were consistent across the 3 villages.Conclusions: Geospatial analysis did not predict community transmission from vaccinated to unvaccinated households, because OPV use resulted in rapid, low transmission levels. This finding supports the global cessation of OPV.

  View details for PubMedID 30376089

• Lab Protocol Paper: Use of a High-throughput, Multiplex Reverse-transcription Quantitative Polymerase Chain Reaction Assay for Detection of Sabin Oral Polio Vaccine in Fecal Samples. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America van Hoorebeke, C., Huang, C., Leary, S., Holubar, M., Altamirano, J., Halpern, M. S., Sommer, M., Maldonado, Y. 2018; 67 (suppl_1): S121–S126

  Abstract

  Background: Global polio eradication efforts rely in part on molecular methods of detecting polioviruses, both wild and vaccine strains, from human and environmental samples. Previous assays used for detection of Sabin oral polio vaccine (OPV) in fecal samples have been labor and time intensive and vary in their sensitivity and specificity.Methods: We developed a high-throughput, multiplex reverse-transcription quantitative polymerase chain reaction assay able to detect all 3 OPV strains in fecal samples. The assay used a KingFisher Duo Prime system for viral RNA isolation and extraction. Positive samples were retested and Sanger sequenced for verification of Sabin serotype identity.Results: The 95% lower limit of detection was determined to be 3 copies per reaction for Sabin 1 and 3 and 4 copies per reaction for Sabin 2, with no cross-reactivity between the 3 serotypes and their primers. A total of 554 samples (3.6%) were positive, with 304 positive samples (54.9%) containing >1 serotype. Of the positive samples, 476 (85.9%) contained enough RNA to be sequenced, and of these all sequences were Sabin serotypes. The previous assay we used could process 48 samples in a 10-hour period, whereas the new assay processed >100 samples in 6 hours.Conclusions: The new high-throughput, multiplex reverse-transcription quantitative polymerase chain reaction assay allowed for sensitive and specific detection of OPV serotypes while greatly decreasing sample handling and processing time. We were able to sequence 72.4% of the 210 positive samples in the cycle threshold range of 35-37.

  View details for PubMedID 30376092

• Pediatric HIV Infection and Decreased Prevalence of OPV Point Mutations Linked to Vaccine-associated Paralytic Poliomyelitis. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Halpern, M. S., Altamirano, J., Maldonado, Y. 2018; 67 (suppl_1): S78–S84

  Abstract

  Background: Mutations associated with prolonged replication of the attenuated polioviruses found in oral poliovirus vaccine (OPV) can lead to vaccine-derived poliovirus (VDPV) and cause paralysis indistinguishable from that caused by wild poliovirus. In response, the World Health Organization has initiated the transition to exclusive use of inactivated poliovirus vaccine (IPV), with OPV administration in cases of outbreak. However, it is currently unclear how IPV-only vaccination, well known to provide humoral but not mucosal immunity, will impact the development of paralysis causing OPV variants. Children infected with human immunodeficiency virus (HIV) have been documented to show decreased mucosal immunity following OPV vaccination. Thus, HIV-infected children vaccinated with OPV may serve as proxy for children with IPV-only vaccination.Methods: We conducted a prospective study of Zimbabwean infants receiving OPV as part of their routine vaccination schedule. Stool samples collected from OPV-vaccinated children serially until age 24 months were tested for OPV serotypes using a real-time polymerase chain reaction protocol that quantifies the amount of mutant OPV variants found in each sample.Results: Out of 2130 stool samples collected from 402 infants 365 stool samples were OPV positive: 313 from 212 HIV-noninfected (HIV-) infants and 52 from 34 HIV-infected (HIV+) infants. HIV- infants showed significantly higher proportions of OPV mutants when compared to HIV+ infants.Conclusions: HIV infection is associated with a reduced proportion of OPV vaccine associated paralytic polio mutants. These results suggest that OPV administered to individuals previously vaccinated only with IPV will show decreased propensity for OPV mutations.

  View details for PubMedID 30376083

• Characterization of Household and Community Shedding and Transmission of Oral Polio Vaccine in Mexican Communities With Varying Vaccination Coverage. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Altamirano, J., Purington, N., Behl, R., Sarnquist, C., Holubar, M., Garcia-Garcia, L., Ferreyra-Reyes, L., Montero-Campos, R., Cruz-Hervert, L. P., Boyle, S., Modlin, J., van Hoorebeke, C., Leary, S., Huang, C., Sommer, M., Ferreira-Guerrero, E., Delgado-Sanchez, G., Canizales-Quintero, S., Diaz Ortega, J. L., Desai, M., Maldonado, Y. A. 2018; 67 (suppl_1): S4–S17

  Abstract

  Background: The World Health Assembly 2012 Polio Eradication and Endgame Strategic Plan calls for the eventual cessation of all oral polio vaccines (OPVs), to be replaced with inactivated polio vaccine (IPV); however, IPV induces less robust mucosal immunity than OPV. This study characterized household and community OPV shedding and transmission after OPV vaccination within primarily IPV-vaccinated communities.Methods: Households in 3 IPV-vaccinated Mexican communities were randomized to receive 3 levels of OPV vaccination coverage (70%, 30%, or 10%). Ten stool samples were collected from all household members over 71 days. Analysis compared vaccinated subjects, household contacts of vaccinated subjects, and subjects in unvaccinated households. Logistic and Cox regression models were fitted to characterize transmission of OPV by coverage and household vaccination status.Results: Among 148 vaccinated children, 380 household contacts, and 1124 unvaccinated community contacts, 78%, 18%, and 7%, respectively, shed OPV. Community and household contacts showed no differences in transmission (odds ratio [OR], 0.67; 95% confidence interval [CI], .37-1.20), in shedding trajectory (OR, 0.61; 95% CI, .35-1.07), or in time to shedding (hazard ratio, 0.68; 95% CI, .39-1.19). Transmission began as quickly as 1 day after vaccination and persisted as long as 71 days after vaccination. Transmission within unvaccinated households differed significantly across vaccination coverage communities, with the 70% community experiencing the most transmissions (15%), and the 10% community experiencing the least (4%). These trends persisted over time and in the time to first shedding analyses.Conclusions: Transmission did not differ between household contacts of vaccinees and unvaccinated households. Understanding poliovirus transmission dynamics is important for postcertification control.

  View details for PubMedID 30376097

• Validation of a High-throughput, Multiplex, Real-time Qualitative Polymerase Chain Reaction Assay for the Detection of Sabin Oral Polio Vaccine in Environmental Samples. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Altamirano, J., Leary, S., van Hoorebeke, C., Sarnquist, C., Behl, R., Garcia-Garcia, L., Ferreyra-Reyes, L., Huang, C., Sommer, M., Maldonado, Y. 2018; 67 (suppl_1): S98–S102

  Abstract

  Background: Currently, the primary mechanism for poliovirus detection is acute flaccid paralysis (AFP) surveillance, with environmental sampling serving as a complement. However, as AFP cases drop, environmental surveillance will become increasingly critical for poliovirus detection. Mexico provides a natural environment to study oral polio vaccine (OPV) transmission, as it provides routine injected polio vaccine immunization and biannual OPV campaigns in February and May.Methods: As part of a study of OPV transmission in which 155 children were vaccinated with OPV, monthly sewage samples were collected from rivers leading from 3 indigenous Mexican villages (Capoluca, Campo Grande, and Tuxpanguillo) from February to May 2015. Samples were also collected from October 2015 to October 2017, during which time there were standard OPV campaigns. Samples were analyzed for the presence of OPV serotypes, using a real-time qualitative polymerase chain reaction assay capable of detecting as few as 9, 12, and 10 copies/100 L of viral ribonucleic acid for OPV serotypes 1, 2, and 3 (OPV-1, -2, and -3), respectively. Included here are 54 samples, taken up to November 2016.Results: Of the 54 samples, 13 (24%) were positive for OPV. After the vaccination of 155 children in February 2015, OPV was found 2 months after vaccination. After unrestricted OPV administration in February 2016, OPV was detected in sewage up to 8 months after vaccination. OPV-3 was found in 11 of the 13 positive samples (85%), OPV-2 was found in 3 positive samples (23%), and OPV-1 was found in 1 sample (8%).Conclusions: OPV can be detected even when small amounts of the vaccine are introduced into a community, as shown by OPV-positive sewage samples even when only 155 children were vaccinated. When OPV vaccination was unrestricted, sewage samples were positive up to 8 months after vaccination, implying community OPV circulation for at least 8 months. OPV-3 was the serotype most found in these samples, indicating prolonged transmission of OPV-3 when compared to the other serotypes. Future work could compare the phylogenetic variance of OPV isolates from sewage after OPV vaccinations.

  View details for PubMedID 30376093

• OPV Vaccination and Shedding Patterns in Mexican and US Children. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Altamirano, J., Sarnquist, C., Behl, R., Garcia-Garcia, L., Ferreyra-Reyes, L., Leary, S., Maldonado, Y. 2018; 67 (suppl_1): S85–S89

  Abstract

  Background: As wild poliovirus is eradicated and countries switch from oral poliovirus vaccine (OPV) to inactivated poliovirus vaccine (IPV) per World Health Organization recommendations, preventing circulation of vaccine-derived poliovirus (cVDPV) is a top priority. Currently, the impact of prior poliovirus vaccination on OPV shedding is not fully understood.Methods: Stool samples from 2 populations were tested for OPV to assess shedding patterns. 505 samples from 43 US children vaccinated with OPV were collected over 42 days post-vaccination. 1,379 samples from 148 Mexican children vaccinated with OPV were collected over 71 days post-vaccination. Prior vaccination history was recorded for both groups.Results: Seventeen (40%) of the US children had never received poliovirus vaccination while the Mexican children had received at least 2 doses of IPV and 116 (78%) had OPV exposure. In total, 84% of US children and 78% of Mexican children shed OPV (P = .44, Fisher exact test), with a mean shedding duration of 17.4 days for US children and 9.3 days for Mexican children (P < .0001, Wilcoxon-Mann Whitney test).Conclusions: Prior vaccination did not affect the likelihood of shedding, as the US and Mexico cohorts had similar shedding proportions. However, prior vaccination affected shedding duration as the Mexican children, who were largely OPV exposed and all of whom had at least 2 IPV vaccinations, shed OPV for half as long as the US cohort. Since different countries maintain different poliovirus vaccination schedules, it is likely that duration of shedding of OPV varies in populations around the world.

  View details for PubMedID 30376085

• Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges OPEN FORUM INFECTIOUS DISEASES Gomez, C. A., Budvytyte, L. N., Press, C., Zhou, L., McLeod, R., Maldonado, Y., Montoya, J. G., Contopoulos-Ioannidis, D. G. 2018; 5 (10)

  View details for DOI 10.1093/ofid/ofy215

  View details for Web of Science ID 000450291600006

• Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges. Open forum infectious diseases Gomez, C. A., Budvytyte, L. N., Press, C., Zhou, L., McLeod, R., Maldonado, Y., Montoya, J. G., Contopoulos-Ioannidis, D. G. 2018; 5 (10): ofy215

  Abstract

  Background: The cost of conventional serological testing for toxoplasmosis discourages universal adoption of prenatal monthly screening programs to prevent congenital toxoplasmosis. Point-of-care (POC) technology may constitute a cost-effective approach.Methods: We evaluated the diagnostic accuracy of 3 Toxoplasma POC tests against gold-standard testing performed at Palo Alto Medical Foundation Toxoplasma Serology Laboratory (PAMF-TSL). The POC tests included the following: Toxo IgG/IgM Rapid Test (Biopanda) and the OnSite Toxo IgG/IgM Combo-Rapid-test that detect IgG and IgM separately, and the Toxoplasma ICT-IgG-IgM-bk (LDBIO) that detects either or both immunoglobulin IgG/IgM in combination. Samples were selected from PAMF-TSL biobank (n = 210) and Centers for Disease Control and Prevention Toxoplasma 1998 Human Serum Panel (n = 100). Based on PAMF-TSL testing, Toxoplasma-infection status was classified in 4 categories: acute infections (n = 85), chronic infections (n = 85), false-positive Toxoplasma IgM (n = 60), and seronegative (n = 80). The POC testing was performed in duplicate following manufacturer's instructions by investigators blinded to PAMF-TSL results. Sensitivity and specificity were calculated.Results: A total of 1860 POC tests were performed. For detection of Toxoplasma IgG, sensitivity was 100% (170 of 170; 95% confidence interval [CI], 97.8%-100%) for all 3 POC kits; specificity was also comparable at 96.3% (77 of 80; 95% CI, 89.5%-98.9%), 97.5% (78 of 80; 95% CI, 91.3%-99.6%), and 98.8% (79 of 80; 95% CI, 93.2%-99.9%). However, sensitivity for detection of Toxoplasma IgM varied significantly across POC tests: Biopanda, 62.2% (51 of 82; 95% CI, 51.4%-71.9%); OnSite, 28% (23 of 82; 95% CI, 19.5%-38.6%); and LDBIO combined IgG/IgM, 100% (82 of 82; 95% CI, 95.5%-100%). Diagnostic accuracy was significantly higher for the LDBIO POC kit. The POC kits did not exhibit cross-reactivity for false-positive Toxoplasma-IgM sera.Conclusions: The 3 evaluated POC kits revealed optimal sensitivity for Toxoplasma-IgG antibodies. The LDBIO-POC test exhibited 100% sensitivity for the combined detection of IgG/IgM in acute and chronic Toxoplasma infection. Biopanda and Onsite POC tests exhibited poor sensitivity for Toxoplasma-IgM detection.

  View details for PubMedID 30393749

• Rapid, inexpensive, fingerstick, whole-blood, sensitive, specific, point-of-care test for anti-Toxoplasma antibodies PLOS NEGLECTED TROPICAL DISEASES Lykins, J., Li, X., Levigne, P., Zhou, Y., El Bissati, K., Clouser, F., Wallon, M., Morel, F., Leahy, K., El Mansouri, B., Siddiqui, M., Leong, N., Michalowski, M., Irwin, E., Goodall, P., Ismail, M., Christmas, M., Adlaoui, E., Rhajaoui, M., Barkat, A., Cong, H., Begeman, I. J., Lai, B., Contopoulos-Ioannidis, D. G., Montoya, J. G., Maldonado, Y., Ramirez, R., Press, C., Peyron, F., McLeod, R. 2018; 12 (8): e0006536

  View details for PubMedID 30114251

• Update From the Advisory Committee on Immunization Practices JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY O'Leary, S. T., Kimberlin, D. W., Maldonado, Y. A. 2018; 7 (2): 93–99

  Abstract

  The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use in the United States. The group has 15 voting members, each of whom is appointed to a 4-year term. ACIP members and Centers for Disease Control and Prevention (CDC) staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and clinical trial results. The ACIP met on October 25 and 26, 2017, to discuss herpes zoster vaccine, the child/adolescent and adult vaccination schedules, Japanese encephalitis (JE) epidemiology and vaccines, pneumococcal vaccines, anthrax vaccines and disaster preparedness, hepatitis A outbreaks, influenza surveillance and vaccination coverage, vaccine safety, and considerations for a potential third dose of measles-mumps-rubella (MMR) vaccine to combat ongoing mumps outbreaks. Representatives from the American Academy of Pediatrics (AAP) (Y. A. M. and D. W. K.) and the Pediatric Infectious Diseases Society (S. T. O.) were present as liaisons from their respective organizations to the ACIP.

  View details for PubMedID 29741721

• A long-term follow-up of a physician leadership program. Journal of health organization and management Fassiotto, M., Maldonado, Y., Hopkins, J. 2018; 32 (1): 56-68

  Abstract

  Purpose Physician leadership programs serve to develop individual capabilities and to affect organizational outcomes. Evaluations of such programs often focus solely on short-term increases in individual capabilities. The purpose of this paper is to assess long-term individual and organizational outcomes of the Stanford Leadership Development Program. Design/methodology/approach There are three data sources for this mixed-methods study: a follow-up survey in 2013-2014 of program participants ( n=131) and matched (control) non-participants ( n=82) from the 2006 to 2011 program years; promotion and retention data; and qualitative in-person interview data. The authors analyzed survey data across leadership knowledge, skills, and attitudes as well as leadership titles held, following program participation using Pearson's χ2 test of independence. Using logistic regression, the authors analyzed promotion and retention among participants and non-participants. Finally, the authors applied both a grounded theory approach and qualitative content analysis to analyze interview data. Findings Program participants rated higher than non-participants across 25 of 30 items measuring leadership knowledge, skills, and attitudes, and were more likely to hold regional/national leadership titles and to have gained in leadership since program participation. Asian program participants were significantly more likely than Asian non-participants to have been promoted, and women participants were less likely to have left the institution than non-participants. Finally, qualitative interviews revealed the long-term impact of leadership learning and networking, as well as the enduring, sustained impact on the organization of projects undertaken during the program. Originality/value This study is unique in its long-term and comprehensive mixed-methods nature of evaluation to assess individual and organizational impact of a physician leadership program.

  View details for DOI 10.1108/JHOM-08-2017-0208

  View details for PubMedID 29508671

• Safety of Multiple Antigen Exposure in the Childhood Immunization Schedule JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION O'Leary, S. T., Maldonado, Y. A. 2018; 319 (9): 870–71

  View details for PubMedID 29509849

• Associations between women's perceptions of gender relations and self-esteem and self-efficacy in a former conflict zone: baseline findings in South Kivu, DR Congo Sarnquist, C., Behl, R., Talib, A., Altamirano, J., Jerome, B., Inungu, J., Maldonado, Y. ELSEVIER SCI LTD. 2018: S5

  View details for Web of Science ID 000437672000005

• Comparative evidence on harms in pediatric randomized clinical trials from less developed versus more developed countries is limited JOURNAL OF CLINICAL EPIDEMIOLOGY Tedesco, D., Farid-Kapadia, M., Offringa, M., Bhutta, Z. A., Maldonado, Y., Ioannidis, J. A., Contopoulos-Ioannidis, D. G. 2018; 95: 63–72

  Abstract

  Evaluate comparative harm rates from medical interventions in pediatric randomized clinical trials (RCTs) from more developed (MDCs) and less developed countries (LDCs).Meta-epidemiologic empirical evaluation of Cochrane Database of Systematic Reviews (June 2014) meta-analyses reporting clinically important harm-outcomes (severe adverse events [AEs], discontinuations due to AEs, any AE, and mortality) that included at least one pediatric RCT from MDCs and at least one from LDCs. We estimated relative odds ratios (RORs) for each harm, within each meta-analysis, between RCTs from MDCs and LDCs and calculated random-effects-summary-RORs (sRORs) for each harm across multiple meta-analyses.Only 1% (26/2,363) of meta-analyses with clinically important harm-outcomes in the entire Cochrane Database of Systematic Reviews included pediatric RCTs both from MDCs and LDCs. We analyzed 26 meta-analyses with 244 data sets from pediatric RCTs, 116 from MDCs and 128 from LDCs (64 and 66 unique RCTs respectively). The summary ROR was 0.92 (95% confidence intervals: 0.78-1.08) for severe AEs; 1.13 (0.54-2.34) for discontinuations due to AEs; 1.10 (0.77-1.59) for any AE; and 0.99 (0.61-1.61) for mortality and for the all-harms-combined-end point 0.96 (0.83-1.10). Differences of ROR-point-estimates ≥2-fold between MDCs and LDCs were identified in 35% of meta-analyses.We found no major systematic differences in harm rates in pediatric trials between MDCs and LDCs, but data on harms in children were overall very limited.

  View details for PubMedID 29191447

• Physician Gender Is Associated with Press Ganey Patient Satisfaction Scores in Outpatient Gynecology. Women's health issues : official publication of the Jacobs Institute of Women's Health Rogo-Gupta, L. J., Haunschild, C., Altamirano, J., Maldonado, Y. A., Fassiotto, M. 2018; 28 (3): 281-285

  Abstract

  Patient satisfaction is gaining increasing attention as a quality measure in health care, but the methods used to assess it may negatively impact women physicians.Our objective was to examine the relationship between physician gender and patient satisfaction with outpatient gynecology care as measured by the Press Ganey patient satisfaction survey.This cross-sectional study analyzed 909 Press Ganey patient satisfaction surveys linked to outpatient gynecology visits at a single academic institution (March 2013-August 2014), including self-reported demographics and satisfaction. Surveys are delivered in a standardized fashion electronically and by mail. Surveys were completed by 821 unique patients and 13,780 gynecology visits occurred during the study period. The primary outcome variable was likelihood to recommend (LTR) a physician. We used χ2 tests of independence to assess the effect of demographic concordance on LTR and two generalized estimating equations models were run clustered by physician, with topbox physician LTR as the outcome variable. Analysis was performed in SAS Enterprise Guide 7.1 (SAS, Inc., Cary, NC).Nine hundred nine surveys with complete demographic data were completed by women during the study period (mean age, 49.3 years). Age- and race-concordant patient-physician pairs received significantly higher proportions of top LTR score than discordant pairs (p = .014 and p < .0001, respectively). In contrast, gender-concordant pairs received a significantly lower proportion of top scores than discordant pairs (p = .027). In the generalized estimating equations model adjusting for health care environment, only gender remained statistically significant. Women physicians had significantly lower odds (47%) of receiving a top score (odds ratio, 0.53; 95% CI, 0.37-0.78; p = .001).Women gynecologists are 47% less likely to receive top patient satisfaction scores compared with their male counterparts owing to their gender alone, suggesting that gender bias may impact the results of patient satisfaction questionnaires. Therefore, the results of this and similar questionnaires should be interpreted with great caution until the impact on women physicians is better understood.

  View details for DOI 10.1016/j.whi.2018.01.001

  View details for PubMedID 29429946

• Female Surgeons as Counter Stereotype: The Impact of Gender Perceptions on Trainee Evaluations of Physician Faculty. Journal of surgical education Fassiotto, M., Li, J., Maldonado, Y., Kothary, N. 2018

  Abstract

  Similar to women in Science, Technology, Engineering and Mathematics disciplines, women in medicine are subject to negative stereotyping when they do not adhere to their sex-role expectations. These biases may vary by specialty, largely dependent on the gender's representation in that specialty. Thus, females in male-dominated surgical specialties are especially at risk of stereotype threat. Herein, we present the role of gender expectations using trainee evaluations of physician faculty at a single academic center, over a 5-year period (2010-2014).Using Graduate Medical Education evaluation data of physician faculty from MedHub, we examined the differences in evaluation scores for male and female physicians within specialties that have traditionally had low female representation (e.g., surgical fields) compared to those with average or high female representation (e.g., pediatrics).Stanford Medicine residents and fellows' MedHub ratings of their physician faculty from 2010 to 2014.A total of 3648 evaluations across 1066 physician faculty.Overall, female physicians received lower median scores than their male counterparts across all specialties. When using regression analyses controlling for race, age, rank, and specialty-specific characteristics, the negative effect persists only for female physicians in specialties with low female representation.This finding suggests that female physicians in traditionally male-dominated specialties may face different criteria based on sex-role expectations when being evaluated by trainees. As trainee evaluations play an important role in career advancement decisions, dictate perceptions of quality within academic medical centers and affect overall job satisfaction, we propose that these differences in evaluations based merely on gender stereotypes could account, in part, for the narrowing pipeline of women promoted to higher ranks in academic medicine.

  View details for DOI 10.1016/j.jsurg.2018.01.011

  View details for PubMedID 29402668

• Multistate Outbreak of an Emerging Burkholderia cepacia Complex Strain Associated With Contaminated Oral Liquid Docusate Sodium INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY Akinboyo, I. C., Sick-Samuels, A. C., Singeltary, E., Fackler, J., Ascenzi, J., Carroll, K. C., Maldonado, Y., Brooks, R. B., Benowitz, I., Wilson, L. E., LiPuma, J. J., Milstone, A. M. 2018; 39 (2): 237–39

  View details for PubMedID 29417919

  View details for PubMedCentralID PMC5837050

• Physician Gender Is Associated with Press Ganey Patient Satisfaction Scores in Outpatient Gynecology Women's Health Issues Rogo-Gupta, L. J., Haunschild, C., Altamirano, J., Maldonado, Y., Fassiotto, M. 2018: 281–85

  Abstract

  Patient satisfaction is gaining increasing attention as a quality measure in health care, but the methods used to assess it may negatively impact women physicians.Our objective was to examine the relationship between physician gender and patient satisfaction with outpatient gynecology care as measured by the Press Ganey patient satisfaction survey.This cross-sectional study analyzed 909 Press Ganey patient satisfaction surveys linked to outpatient gynecology visits at a single academic institution (March 2013-August 2014), including self-reported demographics and satisfaction. Surveys are delivered in a standardized fashion electronically and by mail. Surveys were completed by 821 unique patients and 13,780 gynecology visits occurred during the study period. The primary outcome variable was likelihood to recommend (LTR) a physician. We used χ2 tests of independence to assess the effect of demographic concordance on LTR and two generalized estimating equations models were run clustered by physician, with topbox physician LTR as the outcome variable. Analysis was performed in SAS Enterprise Guide 7.1 (SAS, Inc., Cary, NC).Nine hundred nine surveys with complete demographic data were completed by women during the study period (mean age, 49.3 years). Age- and race-concordant patient-physician pairs received significantly higher proportions of top LTR score than discordant pairs (p = .014 and p < .0001, respectively). In contrast, gender-concordant pairs received a significantly lower proportion of top scores than discordant pairs (p = .027). In the generalized estimating equations model adjusting for health care environment, only gender remained statistically significant. Women physicians had significantly lower odds (47%) of receiving a top score (odds ratio, 0.53; 95% CI, 0.37-0.78; p = .001).Women gynecologists are 47% less likely to receive top patient satisfaction scores compared with their male counterparts owing to their gender alone, suggesting that gender bias may impact the results of patient satisfaction questionnaires. Therefore, the results of this and similar questionnaires should be interpreted with great caution until the impact on women physicians is better understood.

  View details for DOI 10.1016/j.whi.2018.01.001

• Assessing the Risk of Vaccine-derived Outbreaks After Reintroduction of Oral Poliovirus Vaccine in Postcessation Settings. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Fu, R. n., Altamirano, J. n., Sarnquist, C. C., Maldonado, Y. A., Andrews, J. R. 2018; 67 (suppl_1): S26–S34

  Abstract

  The Polio Eradication and Endgame Strategic Plan 2013-2018 calls for the gradual withdrawal of oral poliovirus vaccine (OPV) from routine immunization. We aimed to quantify the transmission potential of Sabin strains from OPV when it is reintroduced, accidentally or deliberately, in a community vaccinated with inactivated poliovirus vaccine alone.We built an individual-based stochastic epidemiological model that allows independent spread of 3 Sabin serotypes and differential transmission rates within versus between households. Model parameters were estimated by fitting to data from a prospective cohort in Mexico. We calculated the effective reproductive number for the Mexico cohort and simulated scenarios of Sabin strain resurgence under postcessation conditions, projecting the risk of prolonged circulation, which could lead to circulating vaccine-derived poliovirus (cVDPV).The estimated effective reproductive number for naturally infected individuals was about 1 for Sabin 2 and Sabin 3 (OPV2 and OPV3) in a postcessation setting. Most transmission events occurred between households. We estimated the probability of circulation for >9 months to be (1) <1% for all 3 serotypes when 90% of children <5 years of age were vaccinated in a hypothetical outbreak control campaign; (2) 45% and 24% for Sabin 2 and Sabin 3, respectively, when vaccine coverage dropped to 10%; (3) 37% and 8% for Sabin 2 and Sabin 3, respectively, when a single active shedder appeared in a community.Critical factors determining the risk of cVDPV emergence are the scale at which OPV is reintroduced and the between-household transmission rate for poliovirus, with intermediate values posing the greatest risk.

  View details for PubMedID 30376087

• The Effect of Combination Antiretroviral Therapy Use Among HIV Positive Children on the Hazard of AIDS Using Calendar Year as an Instrumental Variable CURRENT HIV RESEARCH Anglemyer, A., Sturt, A., Maldonado, Y. 2018; 16 (2): 151–57

  Abstract

  Instrumental variable (IV) analyses are a common causal inference technique used in the absence of randomized data. Combination Antiretroviral Therapy (cART) was first introduced in 1996 and calendar periods have been used as a proxy for cART use. However, cART use misclassification can bias IV analyses.We aim to highlight the differences in the effects of antiretroviral therapy on clinical outcomes between the applications of traditional and adapted IV analysis techniques.This study includes children with perinatal human immunodeficiency virus (HIV-1) infection followed from 1988 to 2009. We describe an application of traditional and adapted IV analysis techniques. Noncompliance adjustments were applied to correct the misclassification of cART-use. Weighting the inverse probability of calendar era, the selected covariates were performed to control for variables that may be related to both the IV and outcome.During 48,380 person-days, 78 HIV-positive children progressed to an initial stage-3- defining diagnosis or death. The Intention to Treat (ITT) rate ratio (RR) of stage-3-defining diagnosis or death comparing the pre-cART and cART eras was estimated at 2·67 (95% confidence interval (CI): 1·.47, 4·84). The IV estimator was used to adjust for cART use misclassification, yielding an IV RR of 5·42 (95% CI: 2·99, 9·83). Weighting analyses did not markedly alter the results.cART use decreased progression to stage-3-defining diagnosis or death. The use of noncompliance adjustments for cART misclassification in IV analyses may provide more robust evidence of cART's effectiveness than traditional ITT analysis.

  View details for PubMedID 29629663

• Female Surgeons as Counter Stereotype: The Impact of Gender Perceptions on Trainee Evaluations of Physician Faculty Journal of Surgical Education Fassiotto, M., Li, J., Maldonado, Y., Kothary, N. 2018

  View details for DOI 10.1016/j.jsurg.2018.01.011

• Assessing the individual risk of fecal poliovirus shedding among vaccinated and non-vaccinated subjects following national health weeks in Mexico PLOS ONE Ferreyra-Reyes, L., Pablo Cruz-Hervert, L., Troy, S. B., Huang, C., Sarnquist, C., Delgado-Sanchez, G., Canizales-Quintero, S., Holubar, M., Ferreira-Guerrero, E., Montero-Campos, R., Rodriguez-Alvarez, M., Mongua-Rodriguez, N., Maldonado, Y., Garcia-Garcia, L. 2017; 12 (10): e0185594

  Abstract

  Mexico introduced inactivated polio vaccine (IPV) into its routine immunization (RI) schedule in 2007 but continued to give trivalent oral polio vaccine (tOPV) twice a year during national health weeks (NHW) through 2015.To evaluate individual variables associated with poliovirus (PV) shedding among children with IPV-induced immunity after vaccination with tOPV and their household contacts.We recruited 72 children (both genders, ≤30 months, vaccinated with at least two doses of IPV) and 144 household contacts (both genders, 2 per household, children and adults) between 08/2010 and 09/2010 in Orizaba, Veracruz. Three NHW took place (one before and two after enrollment). We collected fecal samples monthly for 12 months, and tested 2500 samples for polioviruses types 1, 2 and 3 with three serotype-specific singleplex real-time RT-PCR (rRT-PCR) assays. In order to increase the specificity for OPV virus, all positive and 112 negative samples were also processed with a two-step, OPV serotype-specific multiplex rRT-PCR.We estimated adjusted hazard ratios (HR) and 95% CI using Cox proportional hazards regression for recurrent events models accounting for individual clustering to assess the association of individual variables with the shedding of any poliovirus for all participants and stratifying according to whether the participant had received tOPV in the month of sample collection.216 participants were included. Of the 2500 collected samples, using the singleplex rRT-PCR assay, PV was detected in 5.7% (n = 142); PV1 in 1.2% (n = 29), PV2 in 4.1% (n = 103), and PV3 in 1.9% (n = 48). Of the 256 samples processed by multiplex rRT-PCR, PV was detected in 106 (PV1 in 16.41% (n = 42), PV2 in 21.09% (n = 54), and PV3 in 23.05% (n = 59). Both using singleplex and multiplex assays, shedding of OPV among non-vaccinated children and subjects older than 5 years of age living in the same household was associated with shedding of PV2 by a household contact. All models were adjusted by sex, age, IPV vaccination and OPV shedding by the same individual during the previous month of sample collection.Our results provide important evidence regarding the circulation of poliovirus in a mixed vaccination context (IPV+OPV) which mimics the "transitional phase" that occurs when countries use both vaccines simultaneously. Shedding of OPV2 by household contacts was most likely the source of infection of non-vaccinated children and subjects older than 5 years of age living in the same household.

  View details for PubMedID 29023555

• Update From the Advisory Committee on Immunization Practices JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY O'Leary, S. T., Maldonado, Y. A., Byington, C. L. 2017; 6 (3): 215–18

  Abstract

  The Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts, meets 3 times per year to develop recommendations for vaccine use in the United States. The group has 15 voting members, and each member's term is 4 years. ACIP members and Centers for Disease Control and Prevention (CDC) staff discuss the epidemiology of vaccine-preventable diseases and vaccine research, effectiveness, safety data, and clinical trial results. Representatives from the American Academy of Pediatrics (C. L. B. and Y. A. M.) and the Pediatric Infectious Diseases Society (S. T. O.) are present as liaisons to the ACIP. The ACIP met February 22 and 23, 2017, to discuss proposed recommendations regarding vaccination for unprotected infants born to hepatitis B surface antigen (HBsAg)-positive mothers; topics included cost analysis, influenza surveillance, influenza vaccine effectiveness, herpes zoster vaccine, and considerations for meningococcal serogroup B booster doses in groups at increased risk. Updates on mumps epidemiology, Dengue virus vaccines, Zika virus vaccines, adult immunization, and yellow fever vaccine were also provided.

  View details for PubMedID 28903515

• Adverse Events Following Immunization: Will It Happen Again? PEDIATRICS O'Leary, S. T., Maldonado, Y. A. 2017; 140 (3)

  View details for DOI 10.1542/peds.2017-2015

  View details for Web of Science ID 000408820300042

• Point-of-care testing for Toxoplasma gondii IgG/IgM using Toxoplasma ICT IgG-IgM test with sera from the United States and implications for developing countries PLOS NEGLECTED TROPICAL DISEASES Begeman, I. J., Lykins, J., Zhou, Y., Lai, B., Levigne, P., El Bissati, K., Boyer, K., Withers, S., Clouser, F., Noble, A., Rabiah, P., Swisher, C. N., Heydemann, P. T., Contopoulos-Ioannidis, D. G., Montoya, J. G., Maldonado, Y., Ramirez, R., Press, C., Stillwaggon, E., Peyron, F., McLeod, R. 2017; 11 (6): e0005670

  Abstract

  Congenital toxoplasmosis is a serious but preventable and treatable disease. Gestational screening facilitates early detection and treatment of primary acquisition. Thus, fetal infection can be promptly diagnosed and treated and outcomes can be improved.We tested 180 sera with the Toxoplasma ICT IgG-IgM point-of-care (POC) test. Sera were from 116 chronically infected persons (48 serotype II; 14 serotype I-III; 25 serotype I-IIIa; 28 serotype Atypical, haplogroup 12; 1 not typed). These represent strains of parasites infecting mothers of congenitally infected children in the U.S. 51 seronegative samples and 13 samples from recently infected persons known to be IgG/IgM positive within the prior 2.7 months also were tested. Interpretation was confirmed by two blinded observers. A comparison of costs for POC vs. commercial laboratory testing methods was performed.We found that this new Toxoplasma ICT IgG-IgM POC test was highly sensitive (100%) and specific (100%) for distinguishing IgG/IgM-positive from negative sera. Use of such reliable POC tests can be cost-saving and benefit patients.Our work demonstrates that the Toxoplasma ICT IgG-IgM test can function reliably as a point-of-care test to diagnose Toxoplasma gondii infection in the U.S. This provides an opportunity to improve maternal-fetal care by using approaches, diagnostic tools, and medicines already available. This infection has serious, lifelong consequences for infected persons and their families. From the present study, it appears a simple, low-cost POC test is now available to help prevent morbidity/disability, decrease cost, and make gestational screening feasible. It also offers new options for improved prenatal care in low- and middle-income countries.

  View details for PubMedID 28650970

• Detection of Emerging Vaccine-Related Polioviruses by Deep Sequencing. Journal of clinical microbiology Sahoo, M. K., Holubar, M., Huang, C., Mohamed-Hadley, A., Liu, Y., Waggoner, J. J., Troy, S. B., Garcia-Garcia, L., Ferreyra-Reyes, L., Maldonado, Y., Pinsky, B. A. 2017

  Abstract

  Oral poliovirus vaccine can mutate to regain neurovirulence. To date, evaluation of these mutations has been performed primarily on culture-enriched isolates by using conventional Sanger sequencing. We therefore developed a culture-independent, deep-sequencing method targeting the 5' untranslated region (UTR) and P1 genomic region to characterize vaccine-related poliovirus variants. Error analysis of the deep-sequencing method demonstrated reliable detection of poliovirus mutations at levels of <1%, depending on read depth. Sequencing of viral nucleic acids from the stool of vaccinated, asymptomatic children and their close contacts collected during a prospective cohort study in Veracruz, Mexico, revealed no vaccine-derived polioviruses. This was expected given that the longest duration between sequenced sample collection and the end of the most recent national immunization week was 66 days. However, we identified many low-level variants (<5%) distributed across the 5' UTR and P1 genomic region in all three Sabin serotypes, as well as vaccine-related viruses with multiple canonical mutations associated with phenotypic reversion present at high levels (>90%). These results suggest that monitoring emerging vaccine-related poliovirus variants by deep sequencing may aid in the poliovirus endgame and efforts to ensure global polio eradication.

  View details for DOI 10.1128/JCM.00144-17

  View details for PubMedID 28468861

• Evidence That Classroom-Based Behavioral Interventions Reduce Pregnancy-Related School Dropout Among Nairobi Adolescents HEALTH EDUCATION & BEHAVIOR Sarnquist, C., Sinclair, J., Mboya, B. O., Langat, N., Paiva, L., Halpern-Felsher, B., Golden, N. H., Maldonado, Y. A., Baiocchi, M. T. 2017; 44 (2): 297-303

  Abstract

  Purpose To evaluate the effect of behavioral, empowerment-focused interventions on the incidence of pregnancy-related school dropout among girls in Nairobi's informal settlements. Method Retrospective data on pregnancy-related school dropout from two cohorts were analyzed using a matched-pairs quasi-experimental design. The primary outcome was the change in the number of school dropouts due to pregnancy from 1 year before to 1 year after the interventions. Results Annual incidence of school dropout due to pregnancy decreased by 46% in the intervention schools (from 3.9% at baseline to 2.1% at follow-up), whereas the comparison schools remained essentially unchanged (p < .029). Sensitivity analysis shows that the findings are robust to small levels of unobserved bias. Conclusions Results suggest that these behavioral interventions significantly reduced the number of school dropouts due to pregnancy. As there are limited promising studies on behavioral interventions that decrease adolescent pregnancy in low-income settings, this intervention may be an important addition to this toolkit.

  View details for DOI 10.1177/1090198116657777

  View details for Web of Science ID 000398072000012

• Recommended Childhood and Adolescent Immunization Schedule-United States, 2017 PEDIATRICS Byington, C. L., Maldonado, Y. A., Barnett, E. D., Campbell, J. D., Davies, H. D., Lynfield, R., Munoz, F. M., Nolt, D., Nyquist, A. C., O'Leary, S., Rathore, M. H., Sawyer, M. H., Steinbach, W. J., Tan, T. Q., Zaoutis, T. E., Kimberlin, D. W., Brady, M. T., Jackson, M. A., Long, S. S., Bernstein, H. H., Meissner, H. C., Campos-Outcalt, D., Cohn, A. C., Farizo, K. M., Fischer, M., Gellin, B. G., Gorman, R. L., Halasa, N., Robinson, J. L., Deseda-Tous, J., Simon, G. R., Starke, J. R., Frantz, J. M. 2017; 139 (3)

  View details for DOI 10.1542/peds.2016-4007

  View details for Web of Science ID 000395003200063

  View details for PubMedID 28167516

• Impact of vaccine herd-protection effects in cost-effectiveness analyses of childhood vaccinations. A quantitative comparative analysis. PloS one Holubar, M., Stavroulakis, M. C., Maldonado, Y., Ioannidis, J. P., Contopoulos-Ioannidis, D. 2017; 12 (3)

  Abstract

  Inclusion of vaccine herd-protection effects in cost-effectiveness analyses (CEAs) can impact the CEAs-conclusions. However, empirical epidemiologic data on the size of herd-protection effects from original studies are limited.We performed a quantitative comparative analysis of the impact of herd-protection effects in CEAs for four childhood vaccinations (pneumococcal, meningococcal, rotavirus and influenza). We considered CEAs reporting incremental-cost-effectiveness-ratios (ICERs) (per quality-adjusted-life-years [QALY] gained; per life-years [LY] gained or per disability-adjusted-life-years [DALY] avoided), both with and without herd protection, while keeping all other model parameters stable. We calculated the size of the ICER-differences without vs with-herd-protection and estimated how often inclusion of herd-protection led to crossing of the cost-effectiveness threshold (of an assumed societal-willingness-to-pay) of $50,000 for more-developed countries or X3GDP/capita (WHO-threshold) for less-developed countries.We identified 35 CEA studies (20 pneumococcal, 4 meningococcal, 8 rotavirus and 3 influenza vaccines) with 99 ICER-analyses (55 per-QALY, 27 per-LY and 17 per-DALY). The median ICER-absolute differences per QALY, LY and DALY (without minus with herd-protection) were $15,620 (IQR: $877 to $48,376); $54,871 (IQR: $787 to $115,026) and $49 (IQR: $15 to $1,636) respectively. When the target-vaccination strategy was not cost-saving without herd-protection, inclusion of herd-protection always resulted in more favorable results. In CEAs that had ICERs above the cost-effectiveness threshold without herd-protection, inclusion of herd-protection led to crossing of that threshold in 45% of the cases. This impacted only CEAs for more developed countries, as all but one CEAs for less developed countries had ICERs below the WHO-cost-effectiveness threshold even without herd-protection. In several analyses, recommendation for the adoption of the target vaccination strategy depended on the inclusion of the herd protection effect.Inclusion of herd-protection effects in CEAs had a substantial impact in the estimated ICERs and made target-vaccination strategies more attractive options in almost half of the cases where ICERs were above the societal-willingness to pay threshold without herd-protection. More empirical epidemiologic data are needed to determine the size of herd-protection effects across diverse settings and also the size of negative vaccine effects, e.g. from serotype substitution.

  View details for DOI 10.1371/journal.pone.0172414

  View details for PubMedID 28249046

• Adverse Events Following Immunization: Will It Happen Again? Pediatrics O'Leary, S. T., Maldonado, Y. A. 2017; 140 (3)

  View details for PubMedID 28847983

• A long-term follow-up of a physician leadership program Journal of Health Organization and Management Fassiotto, M., Maldonado, Y., Hopkins, J. 2017: 56–68

  Abstract

  Purpose Physician leadership programs serve to develop individual capabilities and to affect organizational outcomes. Evaluations of such programs often focus solely on short-term increases in individual capabilities. The purpose of this paper is to assess long-term individual and organizational outcomes of the Stanford Leadership Development Program. Design/methodology/approach There are three data sources for this mixed-methods study: a follow-up survey in 2013-2014 of program participants ( n=131) and matched (control) non-participants ( n=82) from the 2006 to 2011 program years; promotion and retention data; and qualitative in-person interview data. The authors analyzed survey data across leadership knowledge, skills, and attitudes as well as leadership titles held, following program participation using Pearson's χ2 test of independence. Using logistic regression, the authors analyzed promotion and retention among participants and non-participants. Finally, the authors applied both a grounded theory approach and qualitative content analysis to analyze interview data. Findings Program participants rated higher than non-participants across 25 of 30 items measuring leadership knowledge, skills, and attitudes, and were more likely to hold regional/national leadership titles and to have gained in leadership since program participation. Asian program participants were significantly more likely than Asian non-participants to have been promoted, and women participants were less likely to have left the institution than non-participants. Finally, qualitative interviews revealed the long-term impact of leadership learning and networking, as well as the enduring, sustained impact on the organization of projects undertaken during the program. Originality/value This study is unique in its long-term and comprehensive mixed-methods nature of evaluation to assess individual and organizational impact of a physician leadership program.

  View details for DOI 10.1108/JHOM-08-2017-0208

• Comparative rates of harms in randomized trials from more developed versus less developed countries may be different JOURNAL OF CLINICAL EPIDEMIOLOGY Contopoulos-Ioannidis, D., Tseretopoulou, X., Ancker, M., Walterspiel, J. N., Panagiotou, O. A., Maldonado, Y., Ioannidis, J. P. 2016; 78: 10-21

  Abstract

  We set up to evaluate the relative risk of harms in trials performed in less developed vs. more developed countries.Meta-epidemiologic evaluation using the Cochrane Database of Systematic Reviews. We considered meta-analyses with at least one randomized clinical trial (RCT) in a less developed country and one RCT in a more developed country. We targeted severe adverse events (AEs), discontinuations due to AEs, any AE, organ system-specific AEs, individual AEs, and all discontinuations due to any reason. We estimated the relative odds ratio (ROR) of harms between more and less developed countries for each topic and the summary ROR (sROR) across topics under each category of harms.We identified 42 systematic reviews (128 meta-analyses, 521 independent RCTs). Summary sRORs did not differ significantly from 1.00 for any harm category. Nominally significant RORs were found in only 6/128 meta-analyses. However, in 27% (35/128) of meta-analyses the ROR point estimates indicated relative differences between country settings >2-fold. Considering also ROR 95% confidence intervals, in 92% (118/128) of meta-analyses one could not exclude a 2-fold difference in both directions.We identified limited comparative evidence on harms in trials from these two country settings. Substantial differences in the risk point estimates were common; the potential for modest differences could rarely be excluded with confidence.

  View details for DOI 10.1016/j.jclinepi.2016.02.032

  View details for PubMedID 27063207

• Invasive Fungal Disease in Pediatric Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant. Journal of pediatric hematology/oncology Aftandilian, C., Weinberg, K., Willert, J., Kharbanda, S., Porteus, M., Maldonado, Y., Agarwal, R. 2016; 38 (7): 574-580

  Abstract

  Invasive fungal disease (IFD) remains a major cause of morbidity and mortality in pediatric patients after allogeneic hematopoietic stem cell transplant (HSCT). We analyzed the outcome of 152 consecutive pediatric patients who underwent allogeneic HSCT from 2005 to 2012: 126 of these without a history of IFD and 26 with IFD before HSCT. Antifungal prophylaxis agent was determined by the primary transplant attending. The rate of IFD after HSCT among patients with or without prior IFD was similar (7.7% with and 7.1% without a history of fungal disease before transplant). Mortality in these 2 populations did not differ (35% vs. 28%, P=0.48, χ). Patients deemed at higher risk for IFD were generally placed on voriconazole prophylaxis; however, this did not affect rates of posttransplant IFD. All-cause mortality in patients with posttransplant IFD was significantly higher than those without posttransplant IFD (67% vs. 21%, P<0.0001,χ). Identifying risk factors for posttransplant IFD remains a high priority to improve outcome of HSCT.

  View details for DOI 10.1097/MPH.0000000000000629

  View details for PubMedID 27658021

• Invasive Fungal Disease in Pediatric Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant JOURNAL OF PEDIATRIC HEMATOLOGY ONCOLOGY Aftandilian, C., Weinberg, K., Willert, J., Kharbanda, S., Porteus, M., Maldonado, Y., Agarwal, R. 2016; 38 (7): 574-580

  View details for Web of Science ID 000385523700029

• Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older PEDIATRICS Byington, C. L., Maldonado, Y. A., Barnett, E. D., Davies, H. D., Edwards, K. M., Lynfield, R., Munoz, F. M., Nolt, D. L., Nyquist, A., Rathore, M. H., Sawyer, M. H., Steinbach, W. J., Tan, T. Q., Zaoutis, T. E. 2016; 138 (3)

  Abstract

  This policy statement provides recommendations for the prevention of serogroup B meningococcal disease through the use of 2 newly licensed serogroup B meningococcal vaccines: MenB-FHbp (Trumenba; Wyeth Pharmaceuticals, a subsidiary of Pfizer, Philadelphia, PA) and MenB-4C (Bexsero; Novartis Vaccines, Siena, Italy). Both vaccines are approved for use in persons 10 through 25 years of age. MenB-FHbp is licensed as a 2- or 3-dose series, and MenB-4C is licensed as a 2-dose series for all groups. Either vaccine is recommended for routine use in persons 10 years and older who are at increased risk of serogroup B meningococcal disease (category A recommendation). Persons at increased risk of meningococcal serogroup B disease include the following: (1) persons with persistent complement component diseases, including inherited or chronic deficiencies in C3, C5-C9, properdin, factor D, or factor H or persons receiving eculizumab (Soliris; Alexion Pharmaceuticals, Cheshire, CT), a monoclonal antibody that acts as a terminal complement inhibitor by binding C5 and inhibiting cleavage of C5 to C5A; (2) persons with anatomic or functional asplenia, including sickle cell disease; and (3) healthy persons at increased risk because of a serogroup B meningococcal disease outbreak. Both serogroup B meningococcal vaccines have been shown to be safe and immunogenic and are licensed by the US Food and Drug Administration for individuals between the ages of 10 and 25 years. On the basis of epidemiologic and antibody persistence data, the American Academy of Pediatrics agrees with the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention that either vaccine may be administered to healthy adolescents and young adults 16 through 23 years of age (preferred ages are 16 through 18 years) to provide short-term protection against most strains of serogroup B meningococcal disease (category B recommendation).

  View details for DOI 10.1542/peds.2016-1890

  View details for Web of Science ID 000384002100067

  View details for PubMedID 27573083

• Evidence That Classroom-Based Behavioral Interventions Reduce Pregnancy-Related School Dropout Among Nairobi Adolescents. Health education & behavior Sarnquist, C., Sinclair, J., Omondi Mboya, B., Langat, N., Paiva, L., Halpern-Felsher, B., Golden, N. H., Maldonado, Y. A., Baiocchi, M. T. 2016

  Abstract

  Purpose To evaluate the effect of behavioral, empowerment-focused interventions on the incidence of pregnancy-related school dropout among girls in Nairobi's informal settlements. Method Retrospective data on pregnancy-related school dropout from two cohorts were analyzed using a matched-pairs quasi-experimental design. The primary outcome was the change in the number of school dropouts due to pregnancy from 1 year before to 1 year after the interventions. Results Annual incidence of school dropout due to pregnancy decreased by 46% in the intervention schools (from 3.9% at baseline to 2.1% at follow-up), whereas the comparison schools remained essentially unchanged (p < .029). Sensitivity analysis shows that the findings are robust to small levels of unobserved bias. Conclusions Results suggest that these behavioral interventions significantly reduced the number of school dropouts due to pregnancy. As there are limited promising studies on behavioral interventions that decrease adolescent pregnancy in low-income settings, this intervention may be an important addition to this toolkit.

  View details for PubMedID 27486178

• Results of the Women's Self-Performed Anal Pap Trial in Human Immunodeficiency Virus-Infected Women SEXUALLY TRANSMITTED DISEASES McNeil, C. J., Kong, C. S., Anglemyer, A., Levy, V., Maldonado, Y. 2016; 43 (7): 433-435

  Abstract

  High-risk human papillomavirus anal infections are common in human immunodeficiency virus-infected women. We conducted a cross-over study in 30 women seen in a California human immunodeficiency virus clinic, to test the feasibility of self-performed anal Pap smears. Women found the tests acceptable and feasible. Compared with physician-collected specimens, results were highly concordant for anal cytology (κ = 0.53) and high-risk human papillomavirus typing (κ = 0.59 inclusive of equivocal results, or κ = 0.81 excluding equivocal results).

  View details for DOI 10.1097/OLQ.0000000000000448

  View details for PubMedID 27322044

• Rotavirus Vaccines-OK to Mix and Match. Pediatrics Byington, C. L., Maldonado, Y. 2016; 137 (2): 1-2

  View details for DOI 10.1542/peds.2015-3618

  View details for PubMedID 26823542

• Shedding of Oral Poliovirus Vaccine (OPV) by HIV-Infected and -Uninfected Mothers of OPV-Vaccinated Zimbabwean Infants. Journal of the Pediatric Infectious Diseases Society Holubar, M., Troy, S. B., Nathoo, K., Stranix-Chibanda, L., Musingwini, G., Srinivas, N., Huang, C., Junn, A., Halpern, M. S., Maldonado, Y. A. 2016

  Abstract

  Community circulation of oral poliovirus vaccine (OPV) likely begins with household transmission. We analyzed stool collected from Zimbabwean mothers who were infected with human immunodeficiency virus (HIV) and those who were uninfected with HIV 1 to 24 weeks after infant oral poliovirus vaccination. Overall, only 5% of the mothers had detectable OPV (16 of 304) despite high infant shedding rates. OPV shedding was similar between HIV-infected mothers and those who were uninfected (11 [6.4%] of 171 vs 5 [3.8%] of 133, respectively) and between mothers of HIV-infected infants and those of uninfected infants (2 [3.5%] of 57 vs 9 [6.3%] of 144, respectively). Mothers of vaccinated infants are unlikely to shed OPV, even when they are infected with HIV.

  View details for PubMedID 26759497

• Clustering of Toxoplasma gondii Infections Within Families of Congenitally Infected Infants. Clinical infectious diseases Contopoulos-Ioannidis, D., Wheeler, K. M., Ramirez, R., Press, C., Mui, E., Zhou, Y., Van Tubbergen, C., Prasad, S., Maldonado, Y., Withers, S., Boyer, K. M., Noble, A. G., Rabiah, P., Swisher, C. N., Heydemann, P., Wroblewski, K., Karrison, T., Grigg, M. E., Montoya, J. G., McLeod, R. 2015; 61 (12): 1815-1824

  Abstract

  Family clusters and epidemics of toxoplasmosis in North, Central, and South America led us to determine whether fathers of congenitally infected infants in the National Collaborative Chicago-Based Congenital Toxoplasmosis Study (NCCCTS) have a high incidence of Toxoplasma gondii infection.We analyzed serum samples collected from NCCCTS families between 1981 and 2013. Paternal serum samples were tested for T. gondii antibodies with immunoglobulin (Ig) G dye test and IgM enzyme-linked immunosorbent assay. Additional testing of paternal serum samples was performed with differential-agglutination and IgG avidity tests when T. gondii IgG and IgM results were positive and serum samples were collected by the 1-year visit of the congenitally infected child. Prevalence of paternal seropositivity and incidence of recent infection were calculated. We analyzed whether certain demographics, maternal parasite serotype, risk factors, or maternal/infant clinical manifestations were associated with paternal T. gondii infection status.Serologic testing revealed a high prevalence (29 of 81; 36%) of T. gondii infection in fathers, relative to the average seropositivity rate of 9.8% for boys and men aged 12-49 years in the United States between 1994 and 2004 (P < .001). Moreover, there was a higher-than-expected incidence of recent infections among fathers with serum samples collected by the 1-year visit of their child (6 of 45; 13%; P < .001). No demographic patterns or clinical manifestations in mothers or infants were associated with paternal infections, except for sandbox exposure.The high prevalence of chronic and incidence of recent T. gondii infections in fathers of congenitally infected children indicates that T. gondii infections cluster within families in North America. When a recently infected person is identified, family clustering and community risk factors should be investigated for appropriate clinical management.

  View details for DOI 10.1093/cid/civ721

  View details for PubMedID 26405150

• Assessing the State of Vaccine Confidence in the United States: Recommendations from the National Vaccine Advisory Committee PUBLIC HEALTH REPORTS Orenstein, W. A., Gellin, B. G., Beigi, R. H., Despres, S., Lynfield, R., Maldonado, Y., Mouton, C., Rawlins, W., Rothholz, M. C., Smith, N., Thompson, K., Torres, C., Viswanath, K., Hosbach, P. 2015; 130 (6): 573-595

  View details for Web of Science ID 000364503700006

• Influenza Immunization for All Health Care Personnel: Keep It Mandatory PEDIATRICS Byington, C. L., Maldonado, Y. A., Barnett, E. D., Davies, H. D., Edwards, K. M., Lynfield, R., Munoz, F. M., Nolt, D. L., Nyquist, A., Rathore, M. H., Sawyer, M. H., Steinbach, W. J., Tan, T. Q., Zaoutis, T. E. 2015; 136 (4): 809-818

  View details for DOI 10.1542/peds.2015-2922

  View details for Web of Science ID 000362944300073

  View details for PubMedID 26347432

• Recommendations for Prevention and Control of Influenza in Children, 2015-2016 PEDIATRICS Byington, C. L., Maldonado, Y. A., Barnett, E. D., Davies, H. D., Edwards, K. M., Lynfield, R., Munoz, F. M., Nolt, D. L., Nyquist, A., Rathore, M. H., Sawyer, M. H., Steinbach, W. J., Tan, T. Q., Zaoutis, T. E. 2015; 136 (4): 792-808

  View details for DOI 10.1542/peds.2015-2920

  View details for Web of Science ID 000362944300072

  View details for PubMedID 26347430

• NVAC Statement of Support Regarding Efforts to Better Implement IIS-to-IIS Data Exchange Across Jurisdictions PUBLIC HEALTH REPORTS Orenstein, W. A., Gellin, B. G., Beigi, R. H., Despres, S., LaRussa, P. S., Lynfield, R., Maldonado, Y., Mouton, C., Pisani, A., Rawlins, W., Rothholz, M. C., Smith, N., Stenvig, T. E., Torres, C., Viswanath, K., Hetherington, S., Hosbach, P. 2015; 130 (4): 332-335

  View details for Web of Science ID 000357707100009

• Trends in Hospitalizations for Intussusception in California in Relationship to the Introduction of New Rotavirus Vaccines, 1985-2010. Pediatric infectious disease journal Contopoulos-Ioannidis, D. G., Halpern, M. S., Maldonado, Y. 2015; 34 (7): 712-717

  Abstract

  The new rotavirus vaccines RV5 and RV1 have been associated with small increase in intussusception risk in active vaccine surveillance studies. It is unclear what the impact might be on the overall trends of intussusception hospitalizations at a large population basis.We conducted an ecological study of hospital discharges of infants with intussusception discharge diagnosis using the California Office of Statewide Health Planning and Development database (1985-2010). We measured incidence rates (IR) of intussusception hospitalizations per 100,000 births within 3 periods (1985-1997; 2000-2005; 2006-2010) related to past, pre-introduction and post-introduction of the new rotavirus vaccines. We estimated slopes of yearly IRs within each period, changes in slopes between periods and IR ratios (IRR) of the mean IRs between periods. We did subgroup analyses for 5 age-subgroups. We also analyzed intussusception hospitalizations of infants who also had a surgical repair and/or radiologic reduction procedure code (restricted cohort).We identified 6241 intussusception hospitalizations; 4696 also had pertinent procedure codes. There was an upward trend in yearly IRs during 2006-2010 (+2 excess cases per 100,000 births per year; P = 0.023); the change in slopes between 2006-2010 and 2000-2005 was +3.2 excess cases per 100,000 births per year (P = 0.052), and the IR in 2006-2010 was 10% higher than in 2000-2005 (IRR: 1.10; 95% confidence intervals: 1.01-1.19). The IRR in 2006-2010 versus 2000-2005 for the 6-14 weeks age-subgroup was 1.90 (95% confidence intervals: 1.33-2.74). In the restricted cohort, trends were similar, though not nominally significant.We documented at a population-level a small increased risk in intussusception hospitalizations post-introduction of the new rotavirus vaccines.

  View details for DOI 10.1097/INF.0000000000000653

  View details for PubMedID 26069946

• Seasonal variation of acute toxoplasmic lymphadenopathy in the United States EPIDEMIOLOGY AND INFECTION Contopoulos-Ioannidis, D., Talucod, J., Maldonado, Y., Montoya, J. G. 2015; 143 (9): 1893-1897

  Abstract

  SUMMARY We describe the seasonal variation of acute toxoplasmosis in the United States. Acute toxoplasmic lymphadenopathy (ATL) can be a surrogate of acute toxoplasmosis in patients in whom the date of onset of lymphadenopathy matches the window of acute infection predicted by serological tests performed at a reference laboratory. We used the electronic database of the Palo Alto Medical Foundation Toxoplasma Serology Laboratory (PAMF-TSL) (1997-2011) to identify cases of ATL. We tested the uniformity of distribution of ATL cases per month, across the 12 calendar months, using circular statistics uniformity tests. We identified 112 consecutive cases of ATL. The distribution of cases was not uniform across the 12 calendar months. We observed the highest peak of cases in December and a second highest peak in September. Similar months were identified in patients with acute toxoplasmosis in rural areas in France. The results were similar when we performed weighted analyses, weighting for the total number of Toxoplasma gondii IgG tests performed per month in the PAMF-TSL laboratory. This is the largest study to date of the seasonal variation of ATL in the United States. Physicians should advise high-risk individuals to avoid risk factors associated with T. gondii infections especially around those months.

  View details for DOI 10.1017/S0950268814002945

  View details for PubMedID 25410401

• Comparison of the Immunogenicity of Various Booster Doses of Inactivated Polio Vaccine Delivered Intradermally Versus Intramuscularly to HIV-Infected Adults JOURNAL OF INFECTIOUS DISEASES Troy, S. B., Kouiavskaia, D., Siik, J., Kochba, E., Beydoun, H., Mirochnitchenko, O., Levin, Y., Khardori, N., Chumakov, K., Maldonado, Y. 2015; 211 (12): 1969-1976

  Abstract

  Inactivated polio vaccine (IPV) is necessary for global polio eradication because oral polio vaccine can rarely cause poliomyelitis as it mutates and may fail to provide adequate immunity in immunocompromised populations. However, IPV is unaffordable for many developing countries. Intradermal IPV shows promise as a means to decrease the effective dose and cost of IPV, but prior studies, all using 20% of the standard dose used in intramuscular IPV, resulted in inferior antibody titers.We randomly assigned 231 adults with well-controlled human immunodeficiency virus infection at a ratio of 2:2:2:1 to receive 40% of the standard dose of IPV intradermally, 20% of the standard dose intradermally, the full standard dose intramuscularly, or 40% of the standard dose intramuscularly. Intradermal vaccination was done using the NanoPass MicronJet600 microneedle device.Baseline immunity was 87%, 90%, and 66% against poliovirus serotypes 1, 2, and 3, respectively. After vaccination, antibody titers increased a median of 64-fold. Vaccine response to 40% of the standard dose administered intradermally was comparable to that of the standard dose of IPV administered intramuscularly and resulted in higher (although not significantly) antibody titers. Intradermal administration had higher a incidence of local side effects (redness and itching) but a similar incidence of systemic side effects and was preferred by study participants over intramuscular administration.A 60% reduction in the standard IPV dose without reduction in antibody titers is possible through intradermal administration.

  View details for DOI 10.1093/infdis/jiu841

  View details for PubMedID 25567841

• Immunodeficiency-related vaccine-derived poliovirus (iVDPV) cases: A systematic review and implications for polio eradication VACCINE Guo, J., Bolivar-Wagers, S., Srinivas, N., Holubar, M., Maldonado, Y. 2015; 33 (10): 1235-1242

  Abstract

  Vaccine-derived polioviruses (VDPVs), strains of poliovirus mutated from the oral polio vaccine, pose a challenge to global polio eradication. Immunodeficiency-related vaccine-derived polioviruses (iVDPVs) are a type of VDPV which may serve as sources of poliovirus reintroduction after the eradication of wild-type poliovirus. This review is a comprehensive update of confirmed iVDPV cases published in the scientific literature from 1962 to 2012, and describes clinically relevant trends in reported iVDPV cases worldwide.We conducted a systematic review of published iVDPV case reports from January 1960 to November 2012 from four databases. We included cases in which the patient had a primary immunodeficiency, and the vaccine virus isolated from the patient either met the sequencing definition of VDPV (>1% divergence for serotypes 1 and 3 and >0.6% for serotype 2) and/or was previously reported as an iVDPV by the World Health Organization.We identified 68 iVDPV cases in 49 manuscripts reported from 25 countries and the Palestinian territories. 62% of case patients were male, 78% presented clinically with acute flaccid paralysis, and 65% were iVDPV2. 57% of cases occurred in patients with predominantly antibody immunodeficiencies, and the overall all-cause mortality rate was greater than 60%. The median age at case detection was 1.4 years [IQR: 0.8, 4.5] and the median duration of shedding was 1.3 years [IQR: 0.7, 2.2]. We identified a poliovirus genome VP1 region mutation rate of 0.72% per year and a higher median percent divergence for iVDPV1 cases. More cases were reported from high income countries, which also had a larger age variation and different distribution of immunodeficiencies compared to upper and lower middle-income countries.Our study describes the incidence and characteristics of global iVDPV cases reported in the literature in the past five decades. It also highlights the regional and economic disparities of reported iVDPV cases.

  View details for DOI 10.1016/j.vaccine.2015.01.018

  View details for PubMedID 25600519

• The National Vaccine Advisory Committee: Reducing Patient and Provider Barriers to Maternal Immunizations Approved by the National Vaccine Advisory Committee on June 11, 2014 PUBLIC HEALTH REPORTS Orenstein, W. A., Gellin, B. G., Beigi, R. H., Despres, S., LaRussa, P. S., Lynfield, R., Maldonado, Y., Mouton, C., Pisani, A., Rawlins, W., Rothholz, M. C., Smith, N., Stenvig, T. E., Torres, C., Viswanath, K., Hetherington, S., Hosbach, P. 2015; 130 (1): 10-42

  View details for Web of Science ID 000347660700004

  View details for PubMedID 25552752

  View details for PubMedCentralID PMC4245282

• Authors' responses in response to the letter from Ambrose. Pediatrics Meissner, H. C., Brady, M. T., Byington, C. L., Kimberlin, D. W., Lieberthal, A. S., Maldonado, Y. A., Ralston, S. L., Winterstein, A. 2014; 134 (6): e1782-3

  View details for DOI 10.1542/peds.2014-2901C

  View details for PubMedID 25452650

• Recommendations for Prevention and Control of Influenza in Children, 2014-2015 PEDIATRICS Byington, C. L., Barnett, E. D., Davies, H. D., Edwards, K. M., Jackson, M. A., Maldonado, Y. A., Murray, D. L., Rathore, M. H., Sawyer, M. H., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E. 2014; 134 (5): E1503-E1519

  View details for DOI 10.1542/peds.2014-2413

  View details for Web of Science ID 000344385900030

• Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection PEDIATRICS Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Jackson, M. A., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Rathore, M. H., Sawyer, M. H., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E., Ralston, S. L., Lieberthal, A. S., Meissner, H. C., Alverson, B. K., Baley, J. E., Gadomski, A. M., Johnson, D. W., Light, M. J. 2014; 134 (2): E620-E638

  View details for DOI 10.1542/peds.2014-1666

  View details for Web of Science ID 000340266000042

• The critical need to diversify the clinical and academic workforce. Academic psychiatry Roberts, L. W., Maldonado, Y., Coverdale, J. H., Balon, R., Louie, A. K., Beresin, E. V. 2014; 38 (4): 394-397

  View details for DOI 10.1007/s40596-014-0175-y

  View details for PubMedID 24989990

• Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection PEDIATRICS Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Jackson, M. A., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Rathore, M. H., Sawyer, M. H., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E., Ralston, S. L., Lieberthal, A. S., Meissner, H. C., Alverson, B. K., Baley, J. E., Gadomski, A. M., Johnson, D. W., Light, M. J., Maraqa, N. F., Mendonca, E. A., Phelan, K. J., Zorc, J. J., Stanko-Lopp, D., Hernandez-Cancio, S. 2014; 134 (2): 415-420

  Abstract

  Palivizumab was licensed in June 1998 by the Food and Drug Administration for the reduction of serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at increased risk of severe disease. Since that time, the American Academy of Pediatrics has updated its guidance for the use of palivizumab 4 times as additional data became available to provide a better understanding of infants and young children at greatest risk of hospitalization attributable to RSV infection. The updated recommendations in this policy statement reflect new information regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effect of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of prophylaxis on wheezing, and palivizumab-resistant RSV isolates. This policy statement updates and replaces the recommendations found in the 2012 Red Book.

  View details for DOI 10.1542/peds.2014-1665

  View details for Web of Science ID 000340266000068

  View details for PubMedID 25070315

• Updated Recommendations on the Use of Meningococcal Vaccines PEDIATRICS Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Jackson, M. A., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Rathore, M. H., Sawyer, M. H., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E. 2014; 134 (2): 400-403

  Abstract

  Since the last policy statement from the American Academy of Pediatrics (AAP) concerning meningococcal vaccine was published in 2011, 2 meningococcal conjugate vaccines have been licensed for use in infants (Hib-MenCY-TT and MenACWY-CRM). The Centers for Disease Control and Prevention (CDC) has published new recommendations, "Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices," which have been endorsed by the AAP. However, the CDC recommendations were published before licensure of MenACWY-CRM for infant use. This policy statement updates the AAP recommendations for use of meningococcal vaccines in children and adolescents. A more comprehensive review of background and technical information can be found in the CDC publication.

  View details for DOI 10.1542/peds.2014-1383

  View details for Web of Science ID 000340266000065

  View details for PubMedID 25070306

• Community circulation patterns of oral polio vaccine serotypes 1, 2, and 3 after mexican national immunization weeks. journal of infectious diseases Troy, S. B., Ferreyra-Reyes, L., Huang, C., Sarnquist, C., Canizales-Quintero, S., Nelson, C., Báez-Saldaña, R., Holubar, M., Ferreira-Guerrero, E., García-García, L., Maldonado, Y. A. 2014; 209 (11): 1693-1699

  Abstract

  Background. With wild poliovirus nearing eradication, preventing circulating vaccine-derived poliovirus (cVDPV) by understanding oral polio vaccine (OPV) community circulation is increasingly important. Mexico, where OPV is given only during biannual national immunization weeks (NIWs) but where children receive inactivated polio vaccine (IPV) as part of their primary regimen, provides a natural setting to study OPV community circulation. Methods. In total, 216 children and household contacts in Veracruz, Mexico, were enrolled, and monthly stool samples and questionnaires collected for 1 year; 2501 stool samples underwent RNA extraction, reverse transcription, and real-time polymerase chain reaction (PCR) to detect OPV serotypes 1, 2, and 3. Results. OPV was detected up to 7 months after an NIW, but not at 8 months. In total, 35% of samples collected from children vaccinated the prior month, but only 4% of other samples, contained OPV. Although each serotype was detected in similar proportions among OPV strains shed as a result of direct vaccination, 87% of OPV acquired through community spread was serotype 2 (P < .0001). Conclusions. Serotype 2 circulates longer and is transmitted more readily than serotypes 1 or 3 after NIWs in a Mexican community primarily vaccinated with IPV. This may be part of the reason why most isolated cVDPV has been serotype 2.

  View details for DOI 10.1093/infdis/jit831

  View details for PubMedID 24367038

  View details for PubMedCentralID PMC4017366

• Rape Prevention Through Empowerment of Adolescent Girls PEDIATRICS Sarnquist, C., Omondi, B., Sinclair, J., Gitau, C., Paiva, L., Mulinge, M., Cornfield, D. N., Maldonado, Y. 2014; 133 (5): E1226-E1232

  Abstract

  Sexual assault is a major cause of injury, unplanned pregnancy, HIV infection, and mental health problems worldwide. In parts of sub-Saharan Africa, sexual assault has reached epidemic proportions. This study evaluated the efficacy of an empowerment and self-defense intervention for adolescent girls to decrease the incidence of sexual assault and harassment in Nairobi's large informal settlements.A prospective cohort of 1978 adolescents from 4 neighborhoods near Nairobi were taught empowerment, deescalation, and self-defense skills in six 2-hour sessions. The standard-of-care (SOC) group (n = 428) received a life skills class. Self-reported, anonymous survey data were collected at baseline and 10.5 months after intervention.Annual sexual assault rates decreased from 17.9/100 person-years at baseline to 11.1 at follow-up (rate ratio = 1.61; 95% confidence interval [CI], 1.26-1.86; P < .001); there was no significant change in the SOC group (14.3 to 14.0, rate ratio = 1.02; 95% CI, 0.67-1.57, P = .92). Sexual assault disclosure in the intervention group increased from 56% to 75% (P = .006), compared with a constant incidence of disclosure (53%) in the SOC group. The majority (52.3%) of adolescents in the intervention group reported using skills learned to stop an assault.This intervention decreased sexual assault rates among adolescent girls in Kenya. The intervention was also associated with an increase in the disclosure of assaults, thereby enabling survivors to seek care and support and possibly leading to the identification and prosecution of perpetrators. This model should be adaptable to other settings both in Africa and globally.

  View details for DOI 10.1542/peds.2013-3414

  View details for Web of Science ID 000335236800043

• Rape prevention through empowerment of adolescent girls. Pediatrics Sarnquist, C., Omondi, B., Sinclair, J., Gitau, C., Paiva, L., Mulinge, M., Cornfield, D. N., Maldonado, Y. 2014; 133 (5): e1226-32

  Abstract

  Sexual assault is a major cause of injury, unplanned pregnancy, HIV infection, and mental health problems worldwide. In parts of sub-Saharan Africa, sexual assault has reached epidemic proportions. This study evaluated the efficacy of an empowerment and self-defense intervention for adolescent girls to decrease the incidence of sexual assault and harassment in Nairobi's large informal settlements.A prospective cohort of 1978 adolescents from 4 neighborhoods near Nairobi were taught empowerment, deescalation, and self-defense skills in six 2-hour sessions. The standard-of-care (SOC) group (n = 428) received a life skills class. Self-reported, anonymous survey data were collected at baseline and 10.5 months after intervention.Annual sexual assault rates decreased from 17.9/100 person-years at baseline to 11.1 at follow-up (rate ratio = 1.61; 95% confidence interval [CI], 1.26-1.86; P < .001); there was no significant change in the SOC group (14.3 to 14.0, rate ratio = 1.02; 95% CI, 0.67-1.57, P = .92). Sexual assault disclosure in the intervention group increased from 56% to 75% (P = .006), compared with a constant incidence of disclosure (53%) in the SOC group. The majority (52.3%) of adolescents in the intervention group reported using skills learned to stop an assault.This intervention decreased sexual assault rates among adolescent girls in Kenya. The intervention was also associated with an increase in the disclosure of assaults, thereby enabling survivors to seek care and support and possibly leading to the identification and prosecution of perpetrators. This model should be adaptable to other settings both in Africa and globally.

  View details for DOI 10.1542/peds.2013-3414

  View details for PubMedID 24733880

• Efficacy and Safety of an Extended Nevirapine Regimen in Infants of Breastfeeding Mothers With HIV-1 Infection for Prevention of HIV-1 Transmission (HPTN 046): 18-Month Results of a Randomized, Double-Blind, Placebo-Controlled Trial. Journal of acquired immune deficiency syndromes (1999) Fowler, M. G., Coovadia, H., Herron, C. M., Maldonado, Y., Chipato, T., Moodley, D., Musoke, P., Aizire, J., Manji, K., Stranix-Chibanda, L., Fawzi, W., Chetty, V., Msweli, L., Kisenge, R., Brown, E., Mwatha, A., Eshleman, S. H., Richardson, P., Allen, M., George, K., Andrew, P., Zwerski, S., Mofenson, L. M., Jackson, J. B. 2014; 65 (3): 366-374

  Abstract

  HPTN 046 compared the efficacy and safety of infant nevirapine (NVP) among HIV-exposed breastfed infants randomized at 6 weeks to 6 months to t NVP or placebo to prevent postnatal infection: we report final 18-month outcomes.Randomized, placebo-controlled trial in 4 African countries. Infant diagnostic HIV testing was performed regularly from birth through 18 months. Kaplan-Meier analysis was used to assess 18-month cumulative infant HIV infection, HIV infection/or death, and mortality rates.Between 6 weeks and 6 months, postnatal HIV infection rates were significantly lower among infants receiving daily NVP from 6 weeks to 6 months 1.1% [95% confidence interval (CI): 0.2% to 1.8%], compared with placebo 2.4% (95% CI: 1.3% to 2.6%), P = 0.049, but not significantly lower thereafter. Eighteen-month postnatal infection rates were low: 2.2% (95% CI: 1.1% to 3.3%) versus 3.1% (95% CI: 1.9% to 4.4%), respectively, P = 0.28. Mortality and HIV infection/death did not differ between arms at any age. Infants of women receiving antiretroviral therapy (ART) for their own health had the lowest 18-month postnatal infection rates (0.5%, 95% CI: 0.0% to 1.1%). However, HIV infection/death rates at 18 months were not significantly different for infants of mothers on ART (3.7%, 95% CI: 1.9% to 5.5%), and infants of mothers with CD4 counts of ≥350 cells per cubic millimeter not receiving ART (4.8%, 95% CI: 2.7% to 6.8%; P = 0.46). There were no differences in adverse events between study arms.This trial demonstrated early but not late differences in postnatal HIV transmission among infants randomized at age 6 weeks to extended NVP or placebo, underscoring the importance of continued prophylaxis throughout breastfeeding.

  View details for DOI 10.1097/QAI.0000000000000052

  View details for PubMedID 24189151

• Temporal Trends in Otolaryngologic Findings among HIV-1-infected Children in a Population-based Cohort. Pediatric infectious disease journal Sturt, A. S., Anglemyer, A. T., Dubray, K., Maldonado, Y. A. 2014; 33 (3): e76-80

  Abstract

  Otolaryngologic conditions are common among HIV-1-infected children. In this study, we provide data regarding prevalence of pediatric HIV-1 otolaryngologic manifestations in the era of antiretroviral therapy (ART).We conducted population-based, prospective, multicenter pediatric HIV-1 surveillance among 276 children with perinatally acquired HIV-1 from 1988 to 2009. All Center for Disease Control (CDC) mild, moderate and severe otolaryngologic conditions were evaluated.CDC-defined, HIV-1-related otolaryngologic conditions among the 276 children were: 103, mild; 50, moderate and 20, severe. The majority [23.3% (24/103), 40.0% (20/50) and 50% (10/20)] of mild, moderate and severe diagnoses, respectively, occurred in the first year of life, with 53.4% (55/103), 66.0% (33/50) and 70% (14/20), respectively, occurring in the first 2 years of life. The most frequent diagnoses were otitis media [21% (58/276)] and oropharyngeal thrush [17.4% (48/276)]. There was a temporal decline by cohort in prevalence of mild and moderate otolaryngologic diagnoses which was significant for mild conditions: 90, pre-ART cohort and 13, ART cohort (P < 0.001) and moderate conditions: 47, pre-ART and 3, ART (P < 0.001).In our study, many CDC-defined, HIV-related otolaryngologic conditions occur in the first 2 years of life. Over 22 years of longitudinal follow up, there was a significant decline in prevalence of CDC-defined otolaryngologic conditions by temporal cohorts when comparing pre-ART and ART eras. This finding supports early ART administration to decrease morbidity in HIV-1-positive infants and children as well as current US and World Health Organization guidelines to prevent early HIV disease progression.

  View details for DOI 10.1097/INF.0000000000000034

  View details for PubMedID 23995587

• Temporal trends in otolaryngologic findings among HIV-1-infected children in a population-based cohort. Pediatric infectious disease journal Sturt, A. S., Anglemyer, A. T., Dubray, K., Maldonado, Y. A. 2014; 33 (3): e76-80

  Abstract

  Otolaryngologic conditions are common among HIV-1-infected children. In this study, we provide data regarding prevalence of pediatric HIV-1 otolaryngologic manifestations in the era of antiretroviral therapy (ART).We conducted population-based, prospective, multicenter pediatric HIV-1 surveillance among 276 children with perinatally acquired HIV-1 from 1988 to 2009. All Center for Disease Control (CDC) mild, moderate and severe otolaryngologic conditions were evaluated.CDC-defined, HIV-1-related otolaryngologic conditions among the 276 children were: 103, mild; 50, moderate and 20, severe. The majority [23.3% (24/103), 40.0% (20/50) and 50% (10/20)] of mild, moderate and severe diagnoses, respectively, occurred in the first year of life, with 53.4% (55/103), 66.0% (33/50) and 70% (14/20), respectively, occurring in the first 2 years of life. The most frequent diagnoses were otitis media [21% (58/276)] and oropharyngeal thrush [17.4% (48/276)]. There was a temporal decline by cohort in prevalence of mild and moderate otolaryngologic diagnoses which was significant for mild conditions: 90, pre-ART cohort and 13, ART cohort (P < 0.001) and moderate conditions: 47, pre-ART and 3, ART (P < 0.001).In our study, many CDC-defined, HIV-related otolaryngologic conditions occur in the first 2 years of life. Over 22 years of longitudinal follow up, there was a significant decline in prevalence of CDC-defined otolaryngologic conditions by temporal cohorts when comparing pre-ART and ART eras. This finding supports early ART administration to decrease morbidity in HIV-1-positive infants and children as well as current US and World Health Organization guidelines to prevent early HIV disease progression.

  View details for DOI 10.1097/INF.0000000000000034

  View details for PubMedID 23995587

• Integrating family planning and prevention of mother to child HIV transmission in Zimbabwe. Contraception Sarnquist, C. C., Moyo, P., Stranix-Chibanda, L., Chipato, T., Kang, J. L., Maldonado, Y. A. 2014; 89 (3): 209-214

  Abstract

  The objective was to integrate enhanced family planning (FP) and prevention of mother-to-child HIV transmission services in order to help HIV-positive Zimbabwean women achieve their desired family size and spacing as well as to maximize maternal and child health.HIV-positive pregnant women were enrolled into a standard-of-care (SOC, n=33) or intervention (n=65) cohort, based on study entry date, and followed for 3 months postpartum. The intervention cohort received education sessions aimed at increasing FP use and negotiation power. Both groups received care from nurses with enhanced FP training. Outcomes included FP use, FP knowledge and HIV disclosure, and were assessed with Fisher's Exact Tests, binomial tests and t tests.The intervention cohort reported increased control over condom use (p=.002), increased knowledge about IUDs (p=.002), increased relationship power (p=.01) and increased likelihood of disclosing their HIV status to a partner (p=.04) and having that partner disclose to them (p=.04) when compared to the SOC cohort. Long-acting reversible contraception (LARC) use in both groups increased from ~2% at baseline to >80% at 3 months postpartum (p<.001).FP and sexual negotiation skills and knowledge, as well as HIV disclosure, increased significantly in the intervention cohort. LARC uptake increased significantly in both the intervention and SOC cohorts, likely because both groups received care from nurses with enhanced FP training. Successful service integration models are needed to maximize health outcomes in resource-constrained environments; this intervention is such a model that should be replicable in other settings in sub-Saharan Africa and beyond.This study provides a rigorously evaluated intervention to integrate FP education into ante- and postnatal care for HIV-positive women and also to train providers on FP. Results suggest that this intervention had significant effects on contraception use and communication with sexual partners. This intervention should be adaptable to other areas.

  View details for DOI 10.1016/j.contraception.2013.11.003

  View details for PubMedID 24332254

• Antiretroviral therapy adherence and predictors to adherence in Albania: a cross-sectional study. Journal of infection in developing countries Morrison, S. D., Rashidi, V., Sarnquist, C., Banushi, V. H., Hole, M. K., Barbhaiya, N. J., Gashi, V. H., Osterberg, L., Maldonado, Y., Harxhi, A. 2014; 8 (7): 853-862

  Abstract

  The possibility of an HIV/AIDS epidemic in southeastern Europe (SEE) is not improbable. Thus, an understanding of the current issues surrounding HIV/AIDS care, specifically antiretroviral therapy (ART) adherence, in countries within SEE is critical. This study was conducted to determine the ART adherence characteristics of Albania's HIV-positive population.This cross-sectional study reports initial demographic and adherence characteristics of patients receiving HIV/AIDS treatment in Albania. Retrospective review of pharmacy medications dispensed supplemented reported adherence behavior. Further, an adherence index was utilized to explore adherence more thoroughly.Patient-reported adherence and pharmacy review showed adherence levels of 98.9±4.4% and 97.7±4.7%, respectively. Assessment by adherence index revealed an index level of 91.7±6.7. Factors associated with a score of < 95 on the adherence index were: being partnered (OR = 0.29, 95% CI = 0.09 - 0.98), history of depression (OR = 0.24, 95% CI = 0.08 - 0.76), increased number of barriers to care (OR = 0.80, 95% CI = 0.66 - 0.97), and increased number of current social and medical needs (OR = 0.72, 95% CI = 0.58 - 0.91).Interventions aimed at reducing barriers to care, addressing current medical and social needs, and treating mental health issues may help improve adherence to ART in patients with HIV/AIDS in Albania. With little known about HIV/AIDS in SEE, this study provides guidance on how SEE countries can help prevent a possible rise in the prevalence of HIV given the close link of ART adherence and spread of HIV.

  View details for DOI 10.3855/jidc.3563

  View details for PubMedID 25022295

• Consumption of Raw or Unpasteurized Milk and Milk Products by Pregnant Women and Children PEDIATRICS Maldonado, Y. A., Glode, M. P., Bhatia, J. 2014; 133 (1): 175-179

  Abstract

  Sales of raw or unpasteurized milk and milk products are still legal in at least 30 states in the United States. Raw milk and milk products from cows, goats, and sheep continue to be a source of bacterial infections attributable to a number of virulent pathogens, including Listeria monocytogenes, Campylobacter jejuni, Salmonella species, Brucella species, and Escherichia coli O157. These infections can occur in both healthy and immunocompromised individuals, including older adults, infants, young children, and pregnant women and their unborn fetuses, in whom life-threatening infections and fetal miscarriage can occur. Efforts to limit the sale of raw milk products have met with opposition from those who are proponents of the purported health benefits of consuming raw milk products, which contain natural or unprocessed factors not inactivated by pasteurization. However, the benefits of these natural factors have not been clearly demonstrated in evidence-based studies and, therefore, do not outweigh the risks of raw milk consumption. Substantial data suggest that pasteurized milk confers equivalent health benefits compared with raw milk, without the additional risk of bacterial infections. The purpose of this policy statement was to review the risks of raw milk consumption in the United States and to provide evidence of the risks of infectious complications associated with consumption of unpasteurized milk and milk products, especially among pregnant women, infants, and children.

  View details for DOI 10.1542/peds.2013-3502

  View details for Web of Science ID 000329168400059

  View details for PubMedID 24344105

• Acute Toxoplasma gondii Infection among Family Members in the United States EMERGING INFECTIOUS DISEASES Contopoulos-Ioannidis, D. G., Maldonado, Y., Montoya, J. G. 2013; 19 (12): 1981-1984

  Abstract

  We investigated 32 families of persons with acute toxoplasmosis in which > or = 1 other family member was tested for Toxoplasma gondii infection; 18 (56%) families had > or = 1 additional family member with acute infection. Family members of persons with acute toxoplasmosis should be screened for infection, especially pregnant women and immunocompromised persons.

  View details for DOI 10.3201/eid1912.121892

  View details for Web of Science ID 000327826600012

  View details for PubMedID 24274896

  View details for PubMedCentralID PMC3840881

• HIV Disease Progression in the First Year After Delivery Among African Women Followed in the HPTN 046 Clinical Trial. Journal of acquired immune deficiency syndromes Watts, D. H., Brown, E. R., Maldonado, Y., Herron, C., Chipato, T., Reddy, L., Moodley, D., Nakabiito, C., Manji, K., Fawzi, W., George, K., Richardson, P., Zwerski, S., Coovadia, H., Fowler, M. 2013; 64 (3): 299-306

  Abstract

  Starting lifelong antiretroviral therapy (ART) in HIV-infected pregnant women may decrease HIV progression and transmission, but adherence after delivery may be difficult, especially for asymptomatic women. We evaluated disease progression among HIV-infected women not on ART with CD4⁺ lymphocyte counts above 200 cells per microliter at delivery.We analyzed risk of death, progression to AIDS (stage IV or CD4 < 200 cells per microliter), or to CD4⁺ count <350 1 year after delivery among postpartum women enrolled to a prevention of breastfeeding transmission trial using the Kaplan-Meier method. In the primary analysis, women were censored if ART was initiated.Among 1285 women who were not WHO stage IV or less at 6 weeks postpartum, 49 (4.3%) progressed to stage IV/CD4 <200 cells per microliter or death by 1 year. Progression to CD4 <200 cells per microliter or death occurred among 16 (4.3%) of 441 women with CD4 count of 350-549 cells per microliter and 10 (1.6%) of 713 with CD4 counts >550 cells per microliter at delivery. CD4 <350 cells per microliter by 12 months postpartum occurred among 116 (37.0%) of 350 women with CD4 count 400-549 cells per microliter and 48 (7.4%) of 713 with CD4 count >550 cells per microliter at delivery.Progression to AIDS or CD4 count <350 cells per microliter is uncommon through 1 year postpartum for women with CD4 counts over 550 cells per microliter at delivery, but occurred in over one third of those with CD4 counts under 550 cells per microliter. ART should be continued after delivery or breastfeeding among women with CD4 counts <550 cells per microliter if follow-up and antiretroviral adherence can be maintained.

  View details for DOI 10.1097/QAI.0b013e3182a2123a

  View details for PubMedID 23846568

• Recommendations for Prevention and Control of Influenza in Children, 2013-2014 PEDIATRICS Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Jackson, M. A., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Rathore, M., Sawyer, M., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E. 2013; 132 (4): E1089-E1104

  View details for DOI 10.1542/peds.2013-2377

  View details for Web of Science ID 000325095400034

• Vaccine Poliovirus Shedding and Immune Response to Oral Polio Vaccine in HIV-Infected and -Uninfected Zimbabwean Infants JOURNAL OF INFECTIOUS DISEASES Troy, S. B., Musingwini, G., Halpern, M. S., Huang, C., Stranix-Chibanda, L., Kouiavskaia, D., Shetty, A. K., Chumakov, K., Nathoo, K., Maldonado, Y. A. 2013; 208 (4): 672-678

  Abstract

  Background. With prolonged replication, attenuated polioviruses used in oral polio vaccine (OPV) can mutate into vaccine-derived poliovirus (VDPV) and cause poliomyelitis outbreaks. Individuals with primary humoral immunodeficiencies can become chronically infected with vaccine poliovirus, allowing it to mutate into immunodeficiency-associated VDPV (iVDPV). It is unclear if children perinatally infected with the human immunodeficiency virus (HIV), who have humoral as well as cellular immunodeficiencies, might be sources of iVDPV. Methods. We conducted a prospective study collecting stool and blood samples at multiple time points from Zimbabwean infants receiving OPV according to the national schedule. Nucleic acid extracted from stool was analyzed by real-time polymerase chain reaction for OPV serotypes. Results. We analyzed 825 stool samples: 285 samples from 92 HIV-infected children and 540 from 251 HIV-uninfected children. Poliovirus shedding was similar after 0-2 OPV doses but significantly higher in the HIV-infected versus uninfected children after ≥3 OPV doses, particularly within 42 days of an OPV dose, independent of seroconversion status. HIV infection was not associated with prolonged or persistent poliovirus shedding. HIV infection was associated with significantly lower polio seroconversion rates. Conclusions. HIV infection is associated with decreased mucosal and humoral immune responses to OPV but not the prolonged viral shedding required to form iVDPV.

  View details for DOI 10.1093/infdis/jit208

  View details for Web of Science ID 000322412100017

  View details for PubMedID 23661792

  View details for PubMedCentralID PMC3719901

• Loss of passively acquired maternal antibodies in highly vaccinated populations: an emerging need to define the ontogeny of infant immune responses. journal of infectious diseases Gans, H. A., Maldonado, Y. A. 2013; 208 (1): 1-3

  View details for DOI 10.1093/infdis/jit144

  View details for PubMedID 23661801

• Temporal Trends in Mucocutaneous Findings Among Human Immunodeficiency Virus 1-Infected Children in a Population-Based Cohort PEDIATRIC DERMATOLOGY Sturt, A. S., Anglemyer, A., Berk, D. R., Maldonado, Y. A. 2013; 30 (4): 451-456

  Abstract

  The objective of the study was to determine the prevalence of pediatric human immunodeficiency virus 1 (HIV-1) mucocutaneous manifestations in the era of highly active antiretroviral therapy (HAART). We conducted population-based, prospective, multicenter pediatric HIV-1 surveillance in 276 children with perinatally acquired HIV-1 from 1988 to 2009. Centers for Disease Control and Prevention (CDC)-defined HIV-1 related mucocutaneous conditions among the 276 children were: category A (n = 152), B (n = 60), and C (n = 1). Nearly half of the category A and B diagnoses (43.4% [66/152] and 35.0% [21/60], respectively) occurred in the first year of life, with 59.2% (90/152) and 61.7% (37/60), respectively, occurring in the first 2 years of life. The most frequent infectious diagnosis was oropharyngeal thrush (n = 117, 42.4%); the most common inflammatory diagnosis was diaper dermatitis (n = 71, 25.7%). There was a temporal decline in the prevalence of A (pre-HAART cohort, 123; post-HAART cohort, 29; p < 0.01) and B (pre-HAART, 55; post-HAART, 5; p < 0.01) mucocutaneous diagnoses. In children with perinatal HIV-1, there was a significant decline in CDC category A and B mucocutaneous diagnoses by temporal cohort, consistent with the introduction of antiretroviral medications and HAART. Clinical category A and B mucocutaneous diagnoses were most common in the first 2 years of life, emphasizing the importance of early HIV-1 testing and HAART initiation.

  View details for DOI 10.1111/pde.12020

  View details for Web of Science ID 000321206100022

  View details for PubMedID 23131130

  View details for PubMedCentralID PMC3573247

• Protecting the Public's Health: Critical Functions of the Section 317 Immunization Program-A Report of the National Vaccine Advisory Committee PUBLIC HEALTH REPORTS Orenstein, W. A., Gellin, B. G., Beigi, R. H., Buck, T., Despres, S., LaRussa, P. S., Lynfield, R., Maldonado, Y., Morita, J., Mouton, C., Pisani, A., Rothholz, M. C., Stenvig, T. E., Tan, L. (., Torres, C., Hetherington, S., Lewin, C., Bailowitz, A., Baker, C., Daum, R. S., Douglas, C., Hannan, C., Jarris, P., Rawlins, W., Richardson, V., Salisbury, D. 2013; 128 (2): 78-95

  View details for Web of Science ID 000315537600003

  View details for PubMedID 23450872

  View details for PubMedCentralID PMC3560865

• Antiretroviral Drugs to Prevent Mother-to-Child Transmission of HIV During Breastfeeding CURRENT HIV RESEARCH Shetty, A. K., Maldonado, Y. 2013; 11 (2): 102-125

  Abstract

  In low and middle-income countries (LMIC), transmission of HIV during breastfeeding represents a major public health challenge. Several viral, maternal clinical, immunological and genetic factors, as well as maternal-infant host factors and type of infant feeding may influence the risk of breastfeeding transmission of HIV. The mechanisms of breast milk HIV transmission are poorly understood. For mothers who are healthy and do not need combination antiretroviral therapy for their own health, randomized controlled trials have proven that administration of extended maternal triple-drug antiretroviral (ARV) prophylaxis or extended infant ARV prophylaxis can significantly reduce the risk of HIV transmission during breastfeeding. Based on this evidence, the World Health Organization (WHO) published new guidance in 2010 on the use of ARVs for treating pregnant women, and preventing mother-to-child HIV transmission (PMTCT). Although, remarkable advances have occurred in prevention of postnatal transmission during breastfeeding using antiretroviral strategies, a number of challenges remain. Future research must focus on field studies to evaluate programmatic implementation of new WHO PMTCT regimens, monitor long-term safety of ART exposure during pregnancy and lactation, and study emergence of ARV resistance (in mothers and infected infants despite prophylaxis).

  View details for Web of Science ID 000317098500004

  View details for PubMedID 23432487

• Reproductive Health and Family Planning Needs Among HIV-Infected Women in Sub-Saharan Africa CURRENT HIV RESEARCH Sarnquist, C. C., Rahangdale, L., Maldonado, Y. 2013; 11 (2): 160-168

  Abstract

  Review key topics and recent literature regarding reproductive health and family planning needs for HIV-infected women in Sub-Saharan Africa.Electronic searches performed in PubMed, JSTOR, and Web of Science; identified articles reviewed for inclusion.Most HIV-infected women in Sub-Saharan Africa bear children, and access to antiretroviral therapy may increase childbearing desires and/or fertility, resulting in greater need for contraception. Most contraceptive options can be safely and effectively used by HIV-infected women. Unmet need for contraception is high in this population, with 66- 92% of women reporting not wanting another child (now or ever), but only 20-43% using contraception. During pregnancy and delivery, HIV-infected women need access to prevention of mother-to-child transmission (PMTCT) services, a skilled birth attendant, and quality post-partum care to prevent HIV infection in the infant and maximize maternal health. Providers may lack resources as well as appropriate training and support to provide such services to women with HIV. Innovations in biomedical and behavioral interventions may improve reproductive healthcare for HIV-infected women, but in Sub-Saharan Africa, models of integrating HIV and PMTCT services with family planning and reproductive health services will be important to improve reproductive outcomes.HIV-infected women in Sub-Saharan Africa have myriad needs related to reproductive health, including access to high-quality family planning information and options, high-quality pregnancy care, and trained providers. Integrated services that help prevent unintended pregnancy and optimize maternal and infant health before, during and after pregnancy will both maximize limited resources as well as provide improved reproductive outcomes.

  View details for PubMedID 23432491

• Recommended Childhood and Adolescent Immunization Schedule-United States, 2013 PEDIATRICS Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Glode, M. P., Jackson, M. A., Keyserling, H. L., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E. 2013; 131 (2): 397-400

  View details for DOI 10.1542/peds.2012-3706

  View details for Web of Science ID 000314355100074

• Cultural adaptation of a survey to assess medical providers' knowledge of and attitudes towards HIV/AIDS in Albania. PloS one Morrison, S. D., Rashidi, V., Banushi, V. H., Barbhaiya, N. J., Gashi, V. H., Sarnquist, C., Maldonado, Y., Harxhi, A. 2013; 8 (3)

  Abstract

  Though the HIV/AIDS epidemic in Southeastern Europe is one of low reported prevalence, numerous studies have described the pervasiveness of medical providers' lack of knowledge of HIV/AIDS in the Balkans. This study sought to culturally adapt an instrument to assess medical providers' knowledge of and attitudes towards HIV/AIDS in Albania. Cultural adaptation was completed through development of a survey from previously validated instruments, translation of the survey into Albanian, blinded back translation, expert committee review of the draft instrument, focus group pre-testing with community- and University Hospital Center of Tirana-based physicians and nurses, and test-retest reliability testing. Blinded back translation of the instrument supported the initial translation with slight changes to the idiomatic and conceptual equivalences. Focus group pre-testing generally supported the instrument, yet some experiential and idiomatic changes were implemented. Based on unweighted kappa and/or prevalence adjusted bias adjusted kappa (PABAK), 20 of the 43 questions were deemed statistically significant at kappa and/or PABAK ≥0.5, while 12 others did not cross zero on the 95% confidence interval for kappa, indicating their probable significance. Subsequently, an instrument to assess medical providers' knowledge of and attitudes toward HIV/AIDS for an Albanian population was developed which can be expanded within Albania and potentially to other countries within the Balkans, which have an Albanian-speaking population.

  View details for DOI 10.1371/journal.pone.0059816

  View details for PubMedID 23544101

  View details for PubMedCentralID PMC3609723

• Clostridium difficile Infection in Infants and Children PEDIATRICS Schutze, G. E., Willoughby, R. E., Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Glode, M. P., Jackson, M. A., Keyserling, H. L., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E. 2013; 131 (1): 196-200

  Abstract

  Infections caused by Clostridium difficile in hospitalized children are increasing. The recent publication of clinical practice guidelines for C difficile infection in adults did not address issues that are specific to children. The purpose of this policy statement is to provide the pediatrician with updated information and recommendations about C difficile infections affecting pediatric patients.

  View details for DOI 10.1542/peds.2012-2992

  View details for Web of Science ID 000313012400069

  View details for PubMedID 23277317

• Cultural adaptation of a survey to assess medical providers' knowledge of and attitudes towards HIV/AIDS in Albania. PloS one Morrison, S. D., Rashidi, V., Banushi, V. H., Barbhaiya, N. J., Gashi, V. H., Sarnquist, C., Maldonado, Y., Harxhi, A. 2013; 8 (3): e59816

  Abstract

  Though the HIV/AIDS epidemic in Southeastern Europe is one of low reported prevalence, numerous studies have described the pervasiveness of medical providers' lack of knowledge of HIV/AIDS in the Balkans. This study sought to culturally adapt an instrument to assess medical providers' knowledge of and attitudes towards HIV/AIDS in Albania. Cultural adaptation was completed through development of a survey from previously validated instruments, translation of the survey into Albanian, blinded back translation, expert committee review of the draft instrument, focus group pre-testing with community- and University Hospital Center of Tirana-based physicians and nurses, and test-retest reliability testing. Blinded back translation of the instrument supported the initial translation with slight changes to the idiomatic and conceptual equivalences. Focus group pre-testing generally supported the instrument, yet some experiential and idiomatic changes were implemented. Based on unweighted kappa and/or prevalence adjusted bias adjusted kappa (PABAK), 20 of the 43 questions were deemed statistically significant at kappa and/or PABAK ≥0.5, while 12 others did not cross zero on the 95% confidence interval for kappa, indicating their probable significance. Subsequently, an instrument to assess medical providers' knowledge of and attitudes toward HIV/AIDS for an Albanian population was developed which can be expanded within Albania and potentially to other countries within the Balkans, which have an Albanian-speaking population.

  View details for DOI 10.1371/journal.pone.0059816

  View details for PubMedID 23544101

  View details for PubMedCentralID PMC3609723

• Staphylococcal infections in children, California, USA, 1985-2009. Emerging infectious diseases Gutierrez, K., Halpern, M. S., Sarnquist, C., Soni, S., Arroyo, A. C., Maldonado, Y. 2013; 19 (1): 10-20

  Abstract

  We conducted a retrospective, observational, population-based study to investigate the effect of staphylococcal infections on the hospitalization of children in California during 1985-2009. Hospitalized children with staphylococcal infections were identified through the California Office of Statewide Health Planning and Development discharge database. Infections were categorized as community onset, community onset health care-associated, or hospital onset. Infection incidence was calculated relative to all children and to those hospitalized in acute-care facilities. A total of 140,265 records were analyzed. Overall incidence increased from 49/100,000 population in 1985 to a peak of 83/100,000 in 2006 and dropped to 73/100,000 in 2009. Staphylococcal infections were associated with longer hospital stays and higher risk for death relative to all-cause hospitalizations of children. The number of methicillin-resistant Staphylococcus aureus infections increased, and the number of methicillin-susceptible S. aureus infections remained unchanged. Children <3 years of age, Blacks, and those without private insurance were at higher risk for hospitalization.

  View details for DOI 10.3201/eid1901.111740

  View details for PubMedID 23260060

• Communicating About Vaccines and Vaccine Safety: What Are Medical Residents Learning and What Do They Want to Learn? JOURNAL OF PUBLIC HEALTH MANAGEMENT AND PRACTICE Sarnquist, C., Sawyer, M., Calvin, K., Mason, W., Blumberg, D., Luther, J., Maldonado, Y. 2013; 19 (1): 40-46

  Abstract

  Physicians spend significant amounts of time discussing vaccine safety concerns with patients and parents. This study aimed to better understand the educational needs of US residents regarding vaccine safety communication, primarily by quantifying the vaccine safety communication training that residents currently receive and elucidating residents' preferences around education about vaccines and vaccine safety communication.A mixed-methods needs assessment consisting of focus groups and a survey.A convenience sample of 303 medical residents in pediatrics, family medicine, and internal medicine from across the United States participated in an online, anonymous survey from March through June 2010. In addition, 9 focus groups with 47 resident participants were held. MAIN OUTCOME MEASURES/RESULTS: The sample included residents in pediatrics (239, 80.2%), internal or family medicine (30, 10.1%), and dual medicine-pediatrics (29, 9.7%); 20.6% of the residents reported "not learning" about vaccine safety communication in their residency programs. Preferred learning methods, which were also the most commonly used methods, included didactic lectures and role-modeling/cases. Electronic teaching method were not only less desired but also very rarely utilized. More than 95% of residents reported thinking that vaccine safety communication would be very or somewhat important in their careers.Improving education on vaccine safety communication within US residency programs, as well as offering self-learning opportunities, can better prepare physicians for their careers.

  View details for DOI 10.1097/PHH.0b013e3182495776

  View details for PubMedID 23169402

• Recommendations for Prevention and Control of Influenza in Children, 2012-2013 PEDIATRICS Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Glode, M. P., Jackson, M. A., Keyserling, H. L., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E., Bradley, J. 2012; 130 (4): 780-792

  View details for DOI 10.1542/peds.2012-2308

  View details for Web of Science ID 000309412100069

• Real-time Polymerase Chain Reaction Analysis of Sewage Samples to Determine Oral Polio Vaccine Circulation Duration and Mutation After Mexican National Immunization Weeks. Journal of the Pediatric Infectious Diseases Society Troy, S. B., Ferreyra-Reyes, L., Canizales-Quintero, S., Huang, C., Lee, Y., Báez-Saldaña, R., Ferreira-Guerrero, E., García-García, L., Maldonado, Y. 2012; 1 (3): 223-229

  Abstract

  Oral polio vaccine (OPV) can mutate and cause outbreaks of paralytic poliomyelitis with prolonged replication. After poliovirus eradication, global use of inactivated polio vaccine (IPV) may be needed until all OPV stops circulating. Mexico, where children receive routine IPV but where OPV is given only during biannual national immunization weeks (NIWs), provides a natural setting to study duration of OPV circulation in a community primarily vaccinated with IPV.One-liter sewage samples from four separate arroyos (creeks) near Orizaba, Mexico, were collected monthly for 12 months. Concentrated sewage underwent RNA extraction, reverse transcription, and real-time polymerase chain reaction (PCR) to detect OPV serotypes 1, 2, and 3 and their variants containing the serotype-specific point mutation in the 5' untranslated region associated with neurovirulence.OPV was detected 3, 4, 5, and 7 months after the May 2010 NIW, but was not detected at 6 or 8 months. A second and third NIW occurred in February 2011 and May 2011, and OPV was detected in the sewage monthly after both of these NIW through July 2011 when collection stopped. The OPV detected was primarily serotype 2 and predominantly contained the point mutations in the 5' untranslated region associated with increased neurovirulence.OPV was detected in sewage as late as 7 months after an NIW in a Mexican community primarily vaccinated with IPV, but was not detected at 8 months, suggesting that OPV circulation may have ceased. These data suggest that in communities with high vaccination rates, 1 or 2 years of IPV administration after OPV cessation could be sufficient to prevent outbreaks of paralytic poliomyelitis from vaccine-derived strains.

  View details for DOI 10.1093/jpids/pis062

  View details for PubMedID 23667738

• Measles Vaccine, HIV Infection, and Antiretroviral Therapy-A Window of Opportunity JOURNAL OF INFECTIOUS DISEASES Maldonado, Y. 2012; 206 (4): 466-468

  View details for DOI 10.1093/infdis/jis392

  View details for Web of Science ID 000306667000003

  View details for PubMedID 22693235

• POLICY STATEMENT HPV Vaccine Recommendations PEDIATRICS Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Glode, M. P., Jackson, M. A., Keyserling, H. L., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E. 2012; 129 (3): 602-605

  View details for DOI 10.1542/peds.2011-3865

  View details for Web of Science ID 000302541000064

• Hematologic and Immunologic Parameters in Zimbabwean Infants: A Case for Using Local Reference Intervals to Monitor Toxicities in Clinical Trials JOURNAL OF TROPICAL PEDIATRICS Troy, S. B., Rowhani-Rahbar, A., Dyner, L., Musingwini, G., Shetty, A. K., Woelk, G., Stranix-Chibanda, L., Nathoo, K., Maldonado, Y. A. 2012; 58 (1): 59-62

  Abstract

  Studies investigating novel therapies in African infants report laboratory adverse events based on reference intervals from white Western infants. However, prior studies have shown that reference intervals differ based on ethnicity and geographic location. We calculated reference intervals for Zimbabwean infants by analyzing the hematologic and immunologic values found in 542 blood samples from 269 HIV-uninfected, black, Zimbabwean infants at 3, 5 and 9 months of age. Substantial proportions of the platelet counts (44%), hemoglobins (19%) and mean corpuscular volumes (41%) were outside published normal ranges. The majority (65%) of hemoglobin values qualified as a United States National Institutes of Health Division of AIDS adverse events. The majority (71%) of CD4% values indicated immunodeficiency by World Health Organization criteria. Hematologic and immunologic reference intervals used to evaluate toxicities in pediatric trials in sub-Saharan Africa need to be reevaluated to account for differences in ethnicity, geographic location, nutrition and socioeconomic status.

  View details for DOI 10.1093/tropej/fmr031

  View details for PubMedID 21504989

• Immunologic Response to Oral Polio Vaccine in Human Immunodeficiency Virus-infected and Uninfected Zimbabwean Children PEDIATRIC INFECTIOUS DISEASE JOURNAL Gnanashanmugam, D., Troy, S. B., Musingwini, G., Huang, C., Halpern, M. S., Stranix-Chibanda, L., Shetty, A. K., Kouiavskaia, D., Nathoo, K., Chumakov, K., Maldonado, Y. A. 2012; 31 (2): 176-180

  Abstract

  Poliovirus eradication is dependent on maintaining adequate community-wide levels of serologic protection. Many African countries with conditions that favor continued wild poliovirus propagation also have a high prevalence of pediatric human immunodeficiency virus (HIV) infection. Data are limited regarding the degree of serologic immunity conferred on HIV-infected children after immunization with oral polio vaccine (OPV).This was a cross-sectional study correlating HIV infection and neutralizing antibodies against poliovirus serotypes 1, 2, and 3 in 95 Zimbabwean children 2 months to 2 years of age, born to HIV-infected mothers, who received OPV according to the national schedule.HIV-infected children had significantly lower rates of seroconversion to all 3 poliovirus serotypes than HIV-uninfected children (60%, 67%, and 47% vs. 96%, 100%, and 82%, P = 0.001, 0.0003, and 0.015 for serotypes 1, 2, and 3 in HIV-infected and uninfected children, respectively, after ≥3 OPV doses). Among poliovirus seroconverters, HIV-infected children also had significantly lower geometric mean titers against serotypes 1 and 2 than HIV-uninfected children (geometric mean titers: 198 and 317 vs. 1193 and 1056, P = 0.032 and 0.050, for serotypes 1 and 2, respectively, after ≥3 OPV doses). In addition, HIV-infected children had significantly higher levels of total IgG and significantly lower CD4% and mean weight than HIV-uninfected children. Of note, none of the HIV-infected children were receiving antiretroviral therapy, and 71% had a CD4% indicating severe immunodeficiency.Pediatric HIV infection is associated with a poor serologic response to OPV, which could pose an obstacle to global polio eradication.

  View details for DOI 10.1097/INF.0b013e31823faa5f

  View details for PubMedID 22146742

• Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial LANCET Coovadia, H. M., Brown, E. R., Fowler, M. G., Chipato, T., Moodley, D., Manji, K., Musoke, P., Stranix-Chibanda, L., Chetty, V., Fawzi, W., Nakabiito, C., Msweli, L., Kisenge, R., Guay, L., Mwatha, A., Lynn, D. J., Eshleman, S. H., Richardson, P., George, K., Andrew, P., Mofenson, L. M., Zwerski, S., Maldonado, Y. 2012; 379 (9812): 221-228

  Abstract

  Nevirapine given once-daily for the first 6, 14, or 28 weeks of life to infants exposed to HIV-1 via breastfeeding reduces transmission through this route compared with single-dose nevirapine at birth or neonatally. We aimed to assess incremental safety and efficacy of extension of such prophylaxis to 6 months.In our phase 3, randomised, double-blind, placebo-controlled HPTN 046 trial, we assessed the incremental benefit of extension of once-daily infant nevirapine from age 6 weeks to 6 months. We enrolled breastfeeding infants born to mothers with HIV-1 in four African countries within 7 days of birth. Following receipt of nevirapine from birth to 6 weeks, infants without HIV infection were randomly allocated (by use of a computer-generated permuted block algorithm with random block sizes and stratified by site and maternal antiretroviral treatment status) to receive extended nevirapine prophylaxis or placebo until 6 months or until breastfeeding cessation, whichever came first. The primary efficacy endpoint was HIV-1 infection in infants at 6 months and safety endpoints were adverse reactions in both groups. We used Kaplan-Meier analyses to compare differences in the primary outcome between groups. This study is registered with ClinicalTrials.gov, number NCT00074412.Between June 19, 2008, and March 12, 2010, we randomly allocated 1527 infants (762 nevirapine and 765 placebo); five of whom had HIV-1 infection at randomisation and were excluded from the primary analyses. In Kaplan-Meier analysis, 1·1% (95% CI 0·3-1·8) of infants who received extended nevirapine developed HIV-1 between 6 weeks and 6 months compared with 2·4% (1·3-3·6) of controls (difference 1·3%, 95% CI 0-2·6), equating to a 54% reduction in transmission (p=0·049). However, mortality (1·2% for nevirapine vs 1·1% for placebo; p=0·81) and combined HIV infection and mortality rates (2·3%vs 3·2%; p=0·27) did not differ between groups at 6 months. 125 (16%) of 758 infants given extended nevirapine and 116 (15%) of 761 controls had serious adverse events, but frequency of adverse events, serious adverse events, and deaths did not differ significantly between treatment groups.Nevirapine prophylaxis can safely be used to provide protection from mother-to-child transmission of HIV-1 via breastfeeding for infants up to 6 months of age.US National Institutes of Health.

  View details for DOI 10.1016/S0140-6736(11)61653-X

  View details for Web of Science ID 000299316100036

  View details for PubMedID 22196945

  View details for PubMedCentralID PMC3539769

• Intradermal fractional dose inactivated polio vaccine: A review of the literature VACCINE Nelson, K. S., Janssen, J. M., Troy, S. B., Maldonado, Y. 2012; 30 (2): 121-125

  Abstract

  Oral polio vaccine (OPV) will likely be insufficient to completely eradicate polio due to its propensity to mutate into neurovirulent forms and its inability to produce adequate immunity in certain areas of the world. Inactivated polio vaccine (IPV), a killed vaccine which therefore cannot mutate, may be more effective than OPV in certain populations, and will likely be required for global polio eradication. However, the high cost of IPV is prohibitive in many areas of the world. Intradermal administration has the potential to lower the dose, and thus the cost, of IPV. This article reviews the clinical studies to date on intradermal fractional dose polio vaccination. We conclude that intradermal IPV vaccination shows potential as a means to reduce the cost and increase the ease of administration of IPV, but that additional research is needed to determine the optimal fractional dose, timing, and role of adjuvants in intradermal IPV vaccination as well as the clinical significance of different antibody titers above the threshold for seroconversion.

  View details for DOI 10.1016/j.vaccine.2011.11.018

  View details for PubMedID 22100886

• Timing of Antiretroviral Therapy Initiation and its Impact on Disease Progression in Perinatal Human Immunodeficiency Virus-1 Infection PEDIATRIC INFECTIOUS DISEASE JOURNAL Sturt, A. S., Halpern, M. S., Sullivan, B., Maldonado, Y. A. 2012; 31 (1): 53-60

  Abstract

  Treatment with highly active antiretroviral therapy (HAART) reduces overall perinatal human immunodeficiency virus (HIV) type 1-related mortality. The effect of timing of HAART initiation on reduction of morbidity is not well defined. We evaluated the association of timing of HAART initiation on progression to moderate or severe disease.Retrospective, population-based study of 196 perinatally HIV-infected children followed from birth in northern California from 1988 to 2009.Of 196 children, 58% received HAART and were followed for a median of 6.2 years after HAART initiation. HAART use was associated with improved survival to the age of 5 years: no HAART, 50% versus HAART, 88%; P < 0.0001. However, the advantage of initial HAART over mono or dual therapy transitioning to HAART was small and not statistically significant (P = 0.23). Starting HAART before the development of moderate or severe disease delayed the median age of diagnosis of moderate disease from 0.4 years (interquartile range, [0.3-0.8]) without HAART to 3.0 years ([interquartile range, 1.9-5.8]; P < 0.0001) with HAART. HAART initiation after progression to moderate or severe disease was associated with decreased progression to severe disease or death, respectively (moderate to severe: 8% [3/36] with HAART vs. 84% [70/83] with no HAART, P < 0.0001; severe to death: 9% [6/68] with HAART vs. 73% [49/67] with no HAART, P < 0.0001).In perinatal HIV infection, HAART is associated with delayed progression and reduced mortality regardless of disease severity at HAART initiation. This finding reinforces US guidelines regarding HAART initiation at >1 year of age if children present with most clinical category B diagnoses, regardless of CD4 measurements or plasma HIV RNA level.

  View details for DOI 10.1097/INF.0b013e31823515a2

  View details for PubMedID 21979798

• Meningococcal Conjugate Vaccines Policy Update: Booster Dose Recommendations PEDIATRICS Brady, M. T., Bernstein, H. H., Byington, C. L., Edwards, K. M., Fisher, M. C., Glode, M. P., Jackson, M. A., Keyserling, H. L., Kimberlin, D. W., Maldonado, Y. A., Orenstein, W. A., Schutze, G. E., Willoughby, R. E. 2011; 128 (6): 1213-1218

  Abstract

  The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention and the American Academy of Pediatrics approved updated recommendations for the use of quadravalent (serogroups A, C, W-135, and Y) meningococcal conjugate vaccines (Menactra [Sanofi Pasteur, Swiftwater, PA] and Menveo [Novartis, Basel, Switzerland]) in adolescents and in people at persistent high risk of meningococcal disease. The recommendations supplement previous Advisory Committee on Immunization Practices and American Academy of Pediatrics recommendations for meningococcal vaccinations. Data were reviewed pertaining to immunogenicity in high-risk groups, bactericidal antibody persistence after immunization, current epidemiology of meningococcal disease, meningococcal conjugate vaccine effectiveness, and cost-effectiveness of different strategies for vaccination of adolescents. This review prompted the following recommendations: (1) adolescents should be routinely immunized at 11 through 12 years of age and given a booster dose at 16 years of age; (2) adolescents who received their first dose at age 13 through 15 years should receive a booster at age 16 through 18 years or up to 5 years after their first dose; (3) adolescents who receive their first dose of meningococcal conjugate vaccine at or after 16 years of age do not need a booster dose; (4) a 2-dose primary series should be administered 2 months apart for those who are at increased risk of invasive meningococcal disease because of persistent complement component (eg, C5-C9, properdin, factor H, or factor D) deficiency (9 months through 54 years of age) or functional or anatomic asplenia (2-54 years of age) and for adolescents with HIV infection; and (5) a booster dose should be given 3 years after the primary series if the primary 2-dose series was given from 2 through 6 years of age and every 5 years for persons whose 2-dose primary series or booster dose was given at 7 years of age or older who are at risk of invasive meningococcal disease because of persistent component (eg, C5-C9, properdin, factor H, or factor D) deficiency or functional or anatomic asplenia.

  View details for DOI 10.1542/peds.2011-2380

  View details for Web of Science ID 000298131400067

  View details for PubMedID 22123893

• Levels of self-reported depression and anxiety among HIV-positive patients in Albania: a cross-sectional study CROATIAN MEDICAL JOURNAL Morrison, S. D., Banushi, V. H., Sarnquist, C., Gashi, V. H., Osterberg, L., Maldonado, Y., Harxhi, A. 2011; 52 (5): 622-628

  Abstract

  To gain an initial perspective of mental health issues facing the Human Immunodeficiency Virus (HIV)-positive population at the University Hospital Center of Tirana (UHCT) HIV/AIDS Ambulatory Clinic.From June-August 2009, we conducted semi-structured interviews with 79 patients (93% response rate) at the UHCT HIV/AIDS Ambulatory Clinic. The interviews assessed patient-reported histories of mental health diagnoses, patients' demographics, and current emotional health status.The percentage of patients who reported a history of diagnosis of depression or anxiety was high - 62.3% and 82.3%, respectively. Factors associated with a history of depression included having been diagnosed with anxiety (P<0.001), having a higher number of barriers to care (P<0.001), having a higher number of current medical and social needs (P<0.001), or having not obtained antiretroviral therapy (ART) abroad (P=0.004). Factors associated with a history of anxiety included having been on first-line ART (P=0.008), having been diagnosed with HIV for shorter periods of time (P=0.043), having been diagnosed with depression (P<0.001), having a higher number of current medical and social needs (P=0.035), or having not obtained ART abroad (P=0.003).Mental health problems are widespread among the known HIV-positive patient population in Albania. The high prevalences of anxiety and depression and of dual diagnoses of these conditions suggest the need for more mental health care for HIV-positive patients in Albania.

  View details for DOI 10.3325/cmj.2011.52.622

  View details for PubMedID 21990080

• POLICY STATEMENT Additional Recommendations for Use of Tetanus Toxoid, Reduced-Content Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) PEDIATRICS Brady, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Glode, M. P., Jackson, M. A., Keyserling, H. L., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E. 2011; 128 (4): 809-812

  View details for DOI 10.1542/peds.2011-1752

  View details for Web of Science ID 000295406800059

• POLICY STATEMENT Recommendations for Administering Hepatitis A Vaccine to Contacts of International Adoptees PEDIATRICS Brady, M. T., Bernstein, H. H., Byington, C. L., Edwards, K. M., Fisher, M. C., Glode, M. P., Jackson, M. A., Keyserling, H. L., Kimberlin, D. W., Maldonado, Y. A., Orenstein, W. A., Schutze, G. E., Willoughby, R. E. 2011; 128 (4): 803-804

  View details for DOI 10.1542/peds.2011-1495

  View details for Web of Science ID 000295406800057

• POLICY STATEMENT Recommendations for Prevention and Control of Influenza in Children, 2011-2012 PEDIATRICS Bradyd, M. T., Byington, C. L., Davies, H. D., Edwards, K. M., Glode, M. P., Jackson, M. A., Keyserling, H. L., Maldonado, Y. A., Murray, D. L., Orenstein, W. A., Schutze, G. E., Willoughby, R. E., Zaoutis, T. E. 2011; 128 (4): 813-825

  View details for DOI 10.1542/peds.2011-2295

  View details for Web of Science ID 000295406800060

• POLICY STATEMENT Poliovirus PEDIATRICS Brady, M. T., Bernstein, H. H., Byington, C. L., Edwards, K. M., Fisher, M. C., Glode, M. P., Jackson, M. A., Keyserling, H. L., Kimberlin, D. W., Maldonado, Y. A., Orenstein, W. A., Schutze, G. E., Willoughby, R. E. 2011; 128 (4): 805-808

  View details for DOI 10.1542/peds.2011-1751

  View details for Web of Science ID 000295406800058

• Trends in Hospitalization for Pediatric Pyelonephritis: A Population Based Study of California From 1985 to 2006 JOURNAL OF UROLOGY Copp, H. L., Halpern, M. S., Maldonado, Y., Shortliffe, L. D. 2011; 186 (3): 1028-1034

  Abstract

  We examined trends in pediatric hospitalization for pyelonephritis from 1985 to 2006 and identified factors associated with admission.We performed a population based analysis of hospital discharges using the Office of Statewide Health Planning and Development database to evaluate trends in California regarding pediatric hospitalizations for pyelonephritis from 1985 to 2006. Multivariable logistic regression was performed to identify factors associated with admission for pyelonephritis.A total of 46,300 children were hospitalized for pyelonephritis in California from 1985 to 2006. The overall rate of hospitalization for pyelonephritis increased by greater than 80%, from 17 per 100,000 children in the California population in 1985 to 31 per 100,000 in 2005. This change was primarily due to the nearly ninefold increase in pyelonephritis hospitalizations observed in children younger than 1 year, from 28 per 100,000 in 1985 to 238 per 100,000 in 2005. Among children younger than 1 year males without private insurance and of nonwhite race had increased odds of hospitalization, while females with private insurance and of Asian race had increased odds of hospitalization, compared with nonprivate insurance and white race, respectively.A significant increase in hospital admissions for pyelonephritis, primarily in children younger than 1 year, occurred in California between 1985 and 2006. Further studies are needed to establish the cause of this striking increase and to determine why certain pediatric populations are at increased risk for hospitalization.

  View details for DOI 10.1016/j.juro.2011.04.101

  View details for Web of Science ID 000293688300095

  View details for PubMedID 21784477

• Policy Statement-Recommendations for the Prevention of Perinatal Group B Streptococcal (GBS) Disease PEDIATRICS Baker, C. J., Byington, C. L., Polin, R. A., Brady, M. T., Bernstein, H. H., Byington, C. L., Edwards, K. M., Fisher, M. C., Glode, M. P., Jackson, M. A., Keyserling, H. L., Kimberlin, D. W., Maldonado, Y. A., Orenstein, W. A., Schutze, G. E., Willoughby, R. E., Papile, L., Cummings, J., Baley, J. E., Bhutani, V. K., Carlo, W. A., Kumar, P., Polin, R. A., Tan, R. C., Wang, K. S., Watterberg, K. L. 2011; 128 (3): 611-616

  Abstract

  The Centers for Disease Control and Prevention (CDC) guidelines for the prevention of perinatal group B streptococcal (GBS) disease were initially published in 1996. The American Academy of Pediatrics (AAP) also published a policy statement on this topic in 1997. In 2002, the CDC published revised guidelines that recommended universal antenatal GBS screening; the AAP endorsed these guidelines and published recommendations based on them in the 2003 Red Book. Since then, the incidence of early-onset GBS disease in neonates has decreased by an estimated 80%. However, in 2010, GBS disease remained the leading cause of early-onset neonatal sepsis. The CDC issued revised guidelines in 2010 based on evaluation of data generated after 2002. These revised and comprehensive guidelines, which have been endorsed by the AAP, reaffirm the major prevention strategy--universal antenatal GBS screening and intrapartum antibiotic prophylaxis for culture-positive and high-risk women--and include new recommendations for laboratory methods for identification of GBS colonization during pregnancy, algorithms for screening and intrapartum prophylaxis for women with preterm labor and premature rupture of membranes, updated prophylaxis recommendations for women with a penicillin allergy, and a revised algorithm for the care of newborn infants. The purpose of this policy statement is to review and discuss the differences between the 2002 and 2010 CDC guidelines that are most relevant for the practice of pediatrics.

  View details for DOI 10.1542/peds.2011-1466

  View details for Web of Science ID 000295406100060

  View details for PubMedID 21807694

• Policy Statement-Prevention of Varicella: Update of Recommendations for Use of Quadrivalent and Monovalent Varicella Vaccines in Children PEDIATRICS Brady, M. T., Bernstein, H. H., Byington, C. L., Edwards, K. M., Fisher, M. C., Glode, M. P., Jackson, M. A., Keyserling, H. L., Kimberlin, D. W., Maldonado, Y. A., Orenstein, W. A., Schutze, G. E., Willoughby, R. E. 2011; 128 (3): 630-632

  Abstract

  Two varicella-containing vaccines are licensed for use in the United States: monovalent varicella vaccine (Varivax [Merck & Co, Inc, West Point, PA]) and quadrivalent measles-mumps-rubella-varicella vaccine (MMRV) (ProQuad [Merck & Co, Inc]). It is estimated from postlicensure data that after vaccination at 12 through 23 months of age, 7 to 9 febrile seizures occur per 10,000 children who receive the MMRV, and 3 to 4 febrile seizures occur per 10,000 children who receive the measles-mumps-rubella (MMR) and varicella vaccines administered concurrently but at separate sites. Thus, 1 additional febrile seizure is expected to occur per approximately 2300 to 2600 children 12 to 23 months old vaccinated with the MMRV, when compared with separate MMR and varicella vaccine administration. The period of risk for febrile seizures is from 5 through 12 days after receipt of the vaccine(s). No increased risk of febrile seizures is seen among patients 4 to 6 years of age receiving MMRV. Febrile seizures do not predispose to epilepsy or neurodevelopmental delays later in life and are not associated with long-term health impairment. The American Academy of Pediatrics recommends that either MMR and varicella vaccines separately or the MMRV be used for the first dose of measles, mumps, rubella, and varicella vaccines administered at 12 through 47 months of age. For the first dose of measles, mumps, rubella, and varicella vaccines administered at ages 48 months and older, and for dose 2 at any age (15 months to 12 years), use of MMRV generally is preferred over separate injections of MMR and varicella vaccines.

  View details for DOI 10.1542/peds.2011-1968

  View details for Web of Science ID 000295406100063

  View details for PubMedID 21873692

• ACCEPTABILITY OF ANAL PAP SELF-SCREENING IN HIGH-RISK WOMEN: FINDINGS FROM ENGLISH AND SPANISH FOCUS GROUPS IN NORTHERN CALIFORNIA McNeil, C., Pinera, C., Maldonado, Y., Levy, V. BMJ PUBLISHING GROUP. 2011: A200–A200

  View details for DOI 10.1136/sextrans-2011-050108.234

  View details for Web of Science ID 000302874201130

• Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine A systematic review of the experience in industrialized countries HUMAN VACCINES Giaquinto, C., Dominiak-Felden, G., Van Damme, P., Myint, T., Maldonado, Y. A., Spoulou, V., Mast, T., Staat, M. 2011; 7 (7): 734–48

  Abstract

  The pentavalent rotavirus (RV) vaccine RotaTeq™ has been available in industrialized countries since 2006. Several studies have been conducted to evaluate the benefit of RV vaccination under routine conditions of use. A systematic review of all publicly available data from RotaTeq™ vaccine-effectiveness and vaccination-impact studies in the USA, Europe and Australia between 2006 and February 2010 was undertaken. Depending on the population studied, effectiveness of up to 100% (95% confidence interval 85-100%) associated with decreased hospitalizations for RV gastroenteritis (RVGE) was seen. Vaccination-impact studies demonstrated that the burden of RVGE has been reduced significantly since the introduction of RV vaccination. Evidence included reductions in healthcare utilization due to RVGE (hospitalizations and emergency-department visits reduced by up to 90%), reductions in the magnitude and duration of the RV season as assessed by laboratory testing for RV, and the possible induction of herd immunity.

  View details for DOI 10.4161/hv.7.7.15511

  View details for Web of Science ID 000294453300012

  View details for PubMedID 21734466

• Epidemiologic trends in penile anomalies and hypospadias in the state of California, 1985-2006 JOURNAL OF PEDIATRIC UROLOGY Elliott, C. S., Halpern, M. S., Paik, J., Maldonado, Y., Shortliffe, L. D. 2011; 7 (3): 294-298

  Abstract

  Using statewide data, we evaluated whether the changing incidence of penile anomalies and hypospadias is reflected in the diverse California population of newborn males over the past 20 years.Discharge data from all California hospitals, prepared by the OSHPD (Sacramento, CA) was reviewed for the years 1985-2006 for male infant births with an ICD-9 code (752.6) for hypospadias, epispadias or other penile anomalies. Trends were examined by Generalized Estimation Equations for Poisson regression.From 1985 to 2006, the birth incidence of newborn penile anomalies increased in California from 47 to 57 cases per 10,000 newborn discharges, yet the trend for hypospadias alone appears stable from 1997. The rates for penile anomalies in newborns increased 1.4% annually (p < 0.001). All racial/ethnic groups analyzed showed this increase (p < 0.001 for each). During the study period there was a 2% increase per year in plural births (p < 0.001). Interestingly, the rate of change in penile anomaly incidence was greater in males of plural births compared to their singleton cohorts (2% vs 1% annually) (p < 0.001). The birth incidence of cleft palate, another congenital anomaly known to be stable over time, remained unchanged over this period.From 1985 to 2006 in California the incidence of penile anomalies increased in a statistically significant manner, but the incidence of hypospadias appears stable for the last decade. Our data support the notion that different racial/ethnic groups have distinct incidences of penile anomaly formation and that an association with plural births appears to be present.

  View details for DOI 10.1016/j.jpurol.2011.03.006

  View details for PubMedID 21527236

• BARRIERS TO CARE AND CURRENT MEDICAL AND SOCIAL NEEDS OF HIV-POSITIVE PATIENTS IN ALBANIA CENTRAL EUROPEAN JOURNAL OF PUBLIC HEALTH Morrison, S. D., Banushi, V. H., Sarnquist, C., Gashi, V. H., Osterberg, L., Maldonado, Y., Harxhi, A. 2011; 19 (2): 91-97

  Abstract

  As HIV/AIDS prevalence rises in Eastern Europe, assessment of local epidemics in the bordering Central European region, especially South Eastern Europe, is vital in order to meet treatment and prevention needs. Understanding current medical and social needs and barriers to care experienced by HIV-positive patients in these regions may provide insight into how to best respond to the local epidemics, increase patients' access to treatment, and reduce loss to follow-up.This study assesses the patient characteristics, barriers to care, and current medical and social needs of HIV-positive patients in Albania. Semi-structured interviews were used in this cross-sectional study.We interviewed 79 of 85 patients (93% response rate) followed at the University Hospital Center of Tirana (UHCT) HIV/AIDS Ambulatory Clinic, which represented the majority of patients under HIV care in Albania during 2009.The local HIV epidemic seems to be comprised mainly of heterosexual men who have spent an average of 3.6 years abroad. The vast majority of patients under care at UHCT HIV/AIDS Ambulatory Clinic had experienced barriers to care associated with social stigma (97.4%), lack of knowledge of HIV medical care (76.6%), and medical provider's lack of knowledge of HIV (70.9%). Social needs of the patients were also overwhelmingly unmet (90.0-95.7%).In addressing HIV/AIDS in Albania, it will be crucial to educate the healthcare sector in ways to identify and address barriers to care and current medical and social needs of HIV-positive patients.

  View details for PubMedID 21739899

• Factors Associated With Repeat Pregnancy Among Women in an Area of High HIV Prevalence in Zimbabwe WOMENS HEALTH ISSUES Smee, N., Shetty, A. K., Stranix-Chibanda, L., Chirenje, M., Chipato, T., Maldonado, Y., Portillo, C. 2011; 21 (3): 222-229

  Abstract

  This study examined predictors of repeat pregnancy among women from the Prevention of Mother-to-Child Transmission of HIV (PMTCT) program in Zimbabwe.The study was conducted at urban antenatal clinics in Chitungwiza, a high HIV prevalence urban town on the outskirts of Harare, Zimbabwe. Using a cross-sectional design, 79 HIV-positive and 80 HIV-negative women who had participated in a PMTCT program in their index pregnancy were interviewed in Shona using a standardized questionnaire 24 months after delivery of their index pregnancy. Logistic regression was used to determine whether a relationship exists between repeat pregnancy and HIV status, socioeconomic status, age, Fertility Attitude Score, and previous pregnancy outcomes.In multivariate analysis, factors associated with an increased likelihood of repeat pregnancy were death of a child (odds ratio [OR], 3.9; 95% confidence interval [CI], 1.25-12.52; p = .0019), miscarriage (OR, 3.4; 95% CI, 1.23-9.34; p = .019), and each additional child (OR, 4.6; 95% CI, 1.89-11.52; p = .001). Decreased likelihood of repeat pregnancy was associated with decreased rank order of living conditions (OR, -0.75; 95% CI, 0.55-0.95; p = .021), each additional year of age (OR, -0.86; 95% CI, 0.77-0.97; p = .012), and higher Fertility Attitude Score (OR, -0.76; 95% CI, 0.64-0.91; p = .002).HIV status alone was not significant as a predictor of repeat pregnancy. Women's childbearing intentions are not influenced by the risk of mother-to-child transmission of HIV (MTCT) in this population. Future research is needed to address the cultural attitudes and sexual practices of HIV-positive women in order to minimize the threat of MTCT.

  View details for DOI 10.1016/j.whi.2010.11.005

  View details for Web of Science ID 000290358900006

  View details for PubMedID 21411336

• Use of a Novel Real-Time PCR Assay To Detect Oral Polio Vaccine Shedding and Reversion in Stool and Sewage Samples after a Mexican National Immunization Day JOURNAL OF CLINICAL MICROBIOLOGY Troy, S. B., Ferreyra-Reyes, L., Huang, C., Mahmud, N., Lee, Y., Canizales-Quintero, S., Flaster, H., Baez-Saldana, R., Garcia-Garcia, L., Maldonado, Y. 2011; 49 (5): 1777-1783

  Abstract

  During replication, oral polio vaccine (OPV) can revert to neurovirulence and cause paralytic poliomyelitis. In individual vaccinees, it can acquire specific revertant point mutations, leading to vaccine-associated paralytic poliomyelitis (VAPP). With longer replication, OPV can mutate into vaccine-derived poliovirus (VDPV), which causes poliomyelitis outbreaks similar to those caused by wild poliovirus. After wild poliovirus eradication, safely phasing out vaccination will likely require global use of inactivated polio vaccine (IPV) until cessation of OPV circulation. Mexico, where children receive routine IPV but where OPV is given biannually during national immunization days (NIDs), provides a natural setting to study the duration of OPV circulation in a population primarily vaccinated with IPV. We developed a real-time PCR assay to detect and distinguish revertant and nonrevertant OPV serotype 1 (OPV-1), OPV-2, and OPV-3 from RNA extracted directly from stool and sewage. Stool samples from 124 children and 8 1-liter sewage samples from Orizaba, Veracruz, Mexico, collected 6 to 13 weeks after a NID were analyzed. Revertant OPV-1 was found in stool at 7 and 9 weeks, and nonrevertant OPV-2 and OPV-3 were found in stool from two children 10 weeks after the NID. Revertant OPV-1 and nonrevertant OPV-2 and -3 were detected in sewage at 6 and 13 weeks after the NID. Our real-time PCR assay was able to detect small amounts of OPV in both stool and sewage and to distinguish nonrevertant and revertant serotypes and demonstrated that OPV continues to circulate at least 13 weeks after a NID in a Mexican population routinely immunized with IPV.

  View details for DOI 10.1128/JCM.02524-10

  View details for PubMedID 21411577

• Policy Statement-Rabies-Prevention Policy Update: New Reduced-Dose Schedule PEDIATRICS Brady, M. T., Bernstein, H. H., Byington, C. L., Edwards, K. M., Fisher, M. C., Glode, M. P., Jackson, M. A., Keyserling, H. L., Kimberlin, D. W., Maldonado, Y. A., Orenstein, W. A., Schutze, G. E., Willoughby, R. E. 2011; 127 (4): 785-787

  View details for DOI 10.1542/peds.2011-0095

  View details for Web of Science ID 000289074800062

• Policy Statement-Recommended Childhood and Adolescent Immunization Schedules-United States, 2011 PEDIATRICS Brady, M. T., Bernstein, H. H., Byington, C. L., Edwards, K. M., Fisher, M. C., Glode, M. P., Jackson, M. A., Keyserling, H. L., Kimberlin, D. W., Maldonado, Y. A., Orenstein, W. A., Schutze, G. E., Willoughby, R. E. 2011; 127 (2): 387-U596

  View details for DOI 10.1542/peds.2010-3203

  View details for Web of Science ID 000286805200057

  View details for PubMedID 21285334

• Rural HIV-infected women's access to medical care: ongoing needs in California AIDS CARE-PSYCHOLOGICAL AND SOCIO-MEDICAL ASPECTS OF AIDS/HIV Sarnquist, C. C., Soni, S., Hwang, H., Topol, B. B., Mutima, S., Maldonado, Y. A. 2011; 23 (7): 792-796

  Abstract

  HIV-infected women living in rural areas often have considerably less access to care than their urban and suburban counterparts. In much of the USA, little is known about HIV care among rural populations. This study elucidated barriers to care for rural women in California. Methods included retrospective structured interviews conducted with 64 women living in rural areas and receiving HIV care at 11 California healthcare facilities. Facilities were randomly sampled and all HIV-infected female patients seeking care at those facilities during a specified time period were eligible. The most commonly cited barriers to accessing care included physical health problems that prevented travel to care (32.8%), lack of transportation (31.2%), and lack of ability to navigate the healthcare system (25.0%). Being divorced/separated/widowed (compared to being either married or single) was associated with reporting physical health as a barrier to care (p=0.03); being unemployed (p=0.003) or having to travel 31-90 minutes (p=0.007, compared to less than 31 or greater than 90) were both associated with transportation as a barrier; and speaking English rather than Spanish was associated with reporting "difficulty navigating the system" (p=0.04). Twenty-nine women (45.3%) reported difficulty in traveling to appointments. Overall, 24 (37.5%) women missed an HIV medical appointment in the previous 12-month period, primarily due to their physical health and transportation limitations. Physical health and transportation problems were both the major barriers to accessing health services and the primary reasons for missing HIV care appointments among this population of HIV-infected women living in rural areas. Providing transportation programs and/or mobile clinics, as well as providing support for patients with physical limitations, may be essential to improving access to HIV care in rural areas.

  View details for DOI 10.1080/09540121.2010.516345

  View details for PubMedID 21287418

• Policy Statement-Recommendations for Prevention and Control of Influenza in Children, 2010-2011 PEDIATRICS Brady, M. T., Bernstein, H. H., Byington, C. L., Edwards, K., Fisher, M. C., Glode, M. P., Jackson, M. A., Keyserling, H. L., Kimberlin, D. W., Maldonado, Y., Orenstein, W. A., Schutze, G. E., Willoughby, R. E., Meissner, H. C., Pickering, L. K., Rubin, L. G., O'Dell, J. D., Weinberg, S. T., Baumrin, E. L., Fay, K. E., Frantz, J. 2010; 126 (4): 816-826

  Abstract

  The purpose of this statement is to update current recommendations for routine use of trivalent seasonal influenza vaccine and antiviral medications for the prevention and treatment of influenza in children. The 2009 influenza A (H1N1) pandemic virus is expected to circulate, with infants and children at increased risk of severe illness and death. This year's trivalent seasonal influenza vaccine contains A/California/7/2009 (H1N1)-like antigen (derived from the 2009 pandemic influenza A [H1N1] virus); A/Perth/16/2009 (H3N2)-like antigen; and B/Brisbane/60/2008-like antigen. Pediatricians continue to have a leadership role in the prevention of influenza through vaccine use and public education. In addition, pediatricians should promptly identify influenza infections to enable rapid treatment of influenza, when indicated, to reduce childhood morbidity and mortality.

  View details for DOI 10.1542/peds.2010-2216

  View details for Web of Science ID 000282526100054

  View details for PubMedID 20805143

• Policy Statement-Recommendation for Mandatory Influenza Immunization of All Health Care Personnel PEDIATRICS Bernstein, H. H., Starke, J. R., Brady, M. T., Bernstein, H. H., Byington, C. L., Edwards, K., Fisher, M. C., Glode, M. P., Jackson, M. A., Keyserling, H. L., Kimberlin, D. W., Maldonado, Y., Orenstein, W. A., Schutze, G. E., Willoughby, R. E., Bocchini, J. A., Bradley, J. S. 2010; 126 (4): 809-815

  Abstract

  The purpose of this statement is to recommend implementation of a mandatory influenza immunization policy for all health care personnel. Immunization of health care personnel is a critically important step to substantially reduce health care-associated influenza infections. Despite the efforts of many organizations to improve influenza immunization rates with the use of voluntary campaigns, influenza coverage among health care personnel remains unacceptably low. Mandatory influenza immunization for all health care personnel is ethically justified, necessary, and long overdue to ensure patient safety.

  View details for DOI 10.1542/peds.2010-2376

  View details for Web of Science ID 000282526100053

  View details for PubMedID 20837587

• How Racial and Ethnic Groupings May Mask Disparities: The Importance of Separating Pacific Islanders From Asians in Prenatal Care Data MATERNAL AND CHILD HEALTH JOURNAL Sarnquist, C. C., Grieb, E. M., Maldonado, Y. A. 2010; 14 (4): 635-641

  Abstract

  To understand racial/ethnic differences in prenatal care receipt among Pacific Islanders and Asians, who are often combined into a single A/PI category.Retrospective, population-based data were collected by the Vital Statistics branch of the California Department of Health Services. Approximately 2.6 million records of all live California births with a birth certificate in 2000-2004 were included. Analysis focused on prenatal care receipt and population characteristics associated with lack of adequate prenatal care, especially among Asian and Pacific Islander groups.Pacific Islanders (n = 11,962) were the most likely, compared to any other racial/ethnic group, to have inadequate prenatal care (OR = 2.9, 95% CIs 2.8-3.1), even when controlling for factors known to affect care receipt, specifically maternal age, educational attainment, parity, insurance, geographical region of residence, and maternal place of birth. In contrast, Asian women (n = 295,741) received care closer to that of the White reference group (OR = 1.5, 95% CIs 1.5-1.5). Among Pacific Islanders, Samoans (OR = 3.0, 95% CIs 2.7-3.4) were at particular risk of inadequate care compared to other PI sub-groups.Pacific Islander women received less adequate prenatal care than women of other racial/ethnic groups. The common practice of combining Asians and Pacific Islanders into a single A/PI category may mask needs in the Pacific Islander community. Therefore, in order to continue to reduce health disparities, it may be necessary to collect separate data on these two distinct populations in order to be able to appropriately direct programs and resources.

  View details for DOI 10.1007/s10995-009-0494-x

  View details for PubMedID 19582560

• Validation of the Edinburgh Postnatal Depression Scale among women in a high HIV prevalence area in urban Zimbabwe ARCHIVES OF WOMENS MENTAL HEALTH Chibanda, D., Mangezi, W., Tshimanga, M., Woelk, G., Rusakaniko, P., Stranix-Chibanda, L., Midzi, S., Maldonado, Y., Shetty, A. K. 2010; 13 (3): 201-206

  Abstract

  Despite the significant burden of common mental disorders (CMD) among women in sub Saharan Africa, data on postnatal depression (PND) is very limited, especially in settings with a high HIV prevalence. The Edinburgh Postnatal Depression Scale (EPDS), a widely used screening test for PND has been validated in many countries, but not in Zimbabwe. We assessed the validity of the EPDS scale among postpartum women compared with Diagnostic Manual of Mental Disorders (DSM-IV) criteria for major depression. Six trained community counselors administered the Shona version of the EPDS to a random sample of 210 postpartum HIV-infected and uninfected women attending two primary care clinics in Chitungwiza. All women were subsequently subjected to mental status examination using DSM IV criteria for major depression by 2 psychiatrists, who were blinded to the subject's EPDS scores. Data were analyzed using receiver operating characteristic (ROC) curve analysis. Of the 210 postpartum mothers enrolled, 64 (33%) met DSM IV criteria for depression. Using a cut-off score of 11/12 on the Shona version of the EPDS for depression, the sensitivity was 88%, and specificity was 87%, with a positive predictive value of 74%, a negative predictive value of 94%, and an area under the curve of 0.82. Cronbach's alpha coefficient for the whole scale was 0.87. Conclusion: The Shona version of the EPDS is a reliable and valid tool to screen for PND among HIV-infected and un-infected women in Zimbabwe. Screening for PND should be integrated into routine antenatal and postnatal care in areas with high HIV prevalence.

  View details for DOI 10.1007/s00737-009-0073-6

  View details for Web of Science ID 000277935600004

  View details for PubMedID 19760051

• THE PREVALENCE OF HOSPITALIZATION FOR PYELONEPHRITIS IN CALIFORNIA INCREASES: RESULTS FROM A STATEWIDE HOSPITAL DISCHARGE DATABASE WITH IMPLICATIONS ON A NATIONAL SCALE Copp, H. L., Halpern, M. S., Maldonado, Y., Shortliffe, L. D. ELSEVIER SCIENCE INC. 2009: 166

  View details for DOI 10.1016/S0022-5347(09)60477-8

  View details for Web of Science ID 000264448500464

• Prenatal Screening for Infectious Diseases: An Analysis of Disparities and Adherence to Policy in California 134th Annual Meeting of the American-Public-Health-Association Sheikh, L. A., Sarnquist, C., Grieb, E. M., Sullivan, B., Maldonado, Y. A. SPRINGER/PLENUM PUBLISHERS. 2009: 260–67

  Abstract

  Prenatal infectious diseases are a major cause of mortality and morbidity among newborns, but many are preventable with proper maternal screening and treatment. METHODS; Adherence to prenatal infectious disease screening guidelines and demographic factors that influence adherence were determined utilizing existing data on 1837 live births from 1999-2003.We found higher rates of testing for syphilis (94.54%), rubella (92.69%) and hepatitis B (94.23%) than for HIV (73.82%) and GBS (69.05%). Adherence to testing guidelines varied by both disease and maternal factors. Lack of insurance, geographic location, inadequate prenatal care and incarceration were the main maternal factors associated with lack of testing.Disease screening rates may be improved by reducing socioeconomic barriers to prenatal testing, supporting access to insurance, eliminating provider biases and providing adequate prenatal care.

  View details for DOI 10.1007/s10995-008-0341-5

  View details for PubMedID 18446431

• Increased Uptake of HIV Testing With the Integration of Nurse-Initiated HIV Testing Into Routine Prenatal Care JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES Cohan, D., Sarnquist, C., Gomez, E., Feakins, C., Maldonado, Y., Zetola, N. 2008; 49 (5): 571-573

  View details for Web of Science ID 000261219000020

  View details for PubMedID 19202463

• Patient acceptance of and satisfaction with rapid HIV testing in a labor and delivery setting JOURNAL OF WOMENS HEALTH Rahangdale, L., Sarnquist, C., Maldonado, Y., Cohan, D. 2008; 17 (3): 465-471

  Abstract

  To evaluate women's acceptance of and satisfaction with rapid human immunodeficiency virus (HIV) testing in a labor and delivery (L&D) setting.We conducted a cross-sectional survey of pregnant women who underwent counseling for rapid HIV testing in an L&D unit at a university-affiliated urban hospital from April 1, 2005, to July 15, 2006. Medical chart abstractions were performed for all 158 eligible women, and a convenience sample of 46 women also completed a survey evaluating their satisfaction using a validated decisional conflict scale.Uptake of rapid HIV testing was 98.1% (155 of 158). Overall, 89.1% of the 46 surveyed women reported feeling satisfied with their testing experience, and 82.6% of women reported no decisional conflict in making decisions for rapid testing; 9% of women reported decisional conflict. The median decisional conflict score on a scale of 0-100 was 5 (mean 11.6, SD 16). In addition, most women reported feeling certain about their decision to test (87.0%), feeling informed about testing (76.1%), having high levels of clarity about their values regarding testing (76.1%), and feeling supported in their decision-making process (76.1%).In this study population, there was a high level of acceptance and satisfaction with rapid HIV testing in the L&D setting. Rapid HIV testing is a vital component of perinatal HIV transmission prevention, as well as being an opportunity for women, some of whom have little contact with the healthcare system, to learn their HIV status.

  View details for DOI 10.1089/jwh.2007.0545

  View details for PubMedID 18373491

• Impact of fetal and neonatal viral (and parasitic) infections on later development and disease outcome 61st Nestle Nutrition Pediatric Workshop Maldonado, Y. A. KARGER. 2008: 225–242

  Abstract

  It is estimated that there are 4 million neonatal deaths and an equal number of stillbirths annually, the majority in the developing world. Neonatal deaths account for one third of deaths in children less than 5 years of age, and at least one third of neonatal deaths are related to infections. Infections also account for 80% of deaths in the postneonatal period through 5 years of age. There are several viral and parasitic infections which produce fetal and neonatal morbidity and mortality. Neonatal infections occur during one or more perinatal periods: in utero (congenital), intrapartum (during labor and delivery), and early or late postpartum. Here the term perinatal refers to all of these stages of fetal or neonatal infections. The mechanisms of perinatal viral and parasitic infections vary depending on the specific pathogen, however, all begin with maternal infection. Following maternal infection, organisms may produce indirect placental infection with or without fetal infection, direct fetal or neonatal infection, or primary maternal infection and subsequent perinatal sequelae without either placental or fetal infection. Some pathogens may produce infections by more than one mechanism. This brief report will provide an overview of the pathogenesis, general outcomes, and known pathogens associated with perinatal viral and parasitic infections.

  View details for PubMedID 18196955

• The feasibility of preventing mother-to-child transmission of HIV using peer counselors in Zimbabwe. AIDS research and therapy Shetty, A. K., Marangwanda, C., Stranix-Chibanda, L., Chandisarewa, W., Chirapa, E., Mahomva, A., Miller, A., Simoyi, M., Maldonado, Y. 2008; 5: 17-?

  Abstract

  Prevention of mother-to-child transmission of HIV (PMTCT) is a major public health challenge in Zimbabwe.Using trained peer counselors, a nevirapine (NVP)-based PMTCT program was implemented as part of routine care in urban antenatal clinics.Between October 2002 and December 2004, a total of 19,279 women presented for antenatal care. Of these, 18,817 (98%) underwent pre-test counseling; 10,513 (56%) accepted HIV testing, of whom 1986 (19%) were HIV-infected. Overall, 9696 (92%) of women collected results and received individual post-test counseling. Only 288 men opted for HIV testing. Of the 1807 HIV-infected women who received posttest counseling, 1387 (77%) collected NVP tablet and 727 (40%) delivered at the clinics. Of the 1986 HIV-infected women, 691 (35%) received NVPsd at onset of labor, and 615 (31%) infants received NVPsd. Of the 727 HIV-infected women who delivered in the clinics, only 396 women returned to the clinic with their infants for the 6-week follow-up visit; of these mothers, 258 (59%) joined support groups and 234 (53%) opted for contraception. By the end of the study period, 209 (53%) of mother-infant pairs (n = 396) came to the clinic for at least 3 follow-up visits.Despite considerable challenges and limited resources, it was feasible to implement a PMTCT program using peer counselors in urban clinics in Zimbabwe.

  View details for DOI 10.1186/1742-6405-5-17

  View details for PubMedID 18673571

• Routine offer of antenatal HIV testing ( "opt-out" approach) to prevent mother-to-child transmission of HIV in urban Zimbabwe BULLETIN OF THE WORLD HEALTH ORGANIZATION Chandisarewa, W., Stranix-Chibanda, L., Chirapa, E., Miller, A., Simoyi, M., Mahomva, A., Maldonado, Y., Shetty, A. K. 2007; 85 (11): 843-850

  Abstract

  To assess the impact of routine antenatal HIV testing for preventing mother-to-child transmission of HIV (PMTCT) in urban Zimbabwe.Community counsellors were trained in routine HIV testing policy using a specific training module from June 2005 through November 2005. Key outcomes during the first 6 months of routine testing were compared with the prior 6-month "opt-in" period, and clients were interviewed.Of the 4551 women presenting for antenatal care during the first 6 months of routine HIV testing, 4547 (99.9%) were tested for HIV compared with 3058 (65%) of 4700 women during the last 6 months of the opt-in testing (P < 0.001), with a corresponding increase in the numbers of HIV-infected women identified antenatally (926 compared with 513, P < 0.001). During routine testing, more HIV-infected women collected results compared to the opt-in testing (908 compared with 487, P < 0.001) resulting in a significant increase in deliveries by HIV-infected women (256 compared with 186, P = 0.001); more mother/infant pairs received antiretroviral prophylaxis (n = 256) compared to the opt-in testing (n = 185); and more mother/infant pairs followed up at clinics (105 compared with 49, P = 0.002). Women were satisfied with counselling services and most (89%) stated that offering routine testing is helpful. HIV-infected women reported low levels of spousal abuse and other adverse social consequences.Routine antenatal HIV testing should be implemented at all sites in Zimbabwe to maximize the public health impact of PMTCT.

  View details for DOI 10.2471/BLT.06.035188

  View details for Web of Science ID 000250858300011

  View details for PubMedID 18038074

  View details for PubMedCentralID PMC2636259

• Shedding and reversion of oral polio vaccine type 3 in Mexican vaccinees: Comparison of mutant analysis by PCR and enzyme cleavage to a real-time PCR assay JOURNAL OF CLINICAL MICROBIOLOGY Gnanashanmugam, D., Falkovitz-Halpern, M. S., Dodge, A., Fang, M., Wong, L. J., Esparza, M., Hammon, R., Rivas-Merelles, E. E., Santos, J. I., Maldonado, Y. 2007; 45 (8): 2419-2425

  Abstract

  A uracil-to-cytosine mutation at nucleotide position 472 of oral poliovirus vaccine type 3 (OPV3) contributes to the development of vaccine-associated paralytic poliomyelitis (VAPP). To analyze OPV3 shedding patterns, we previously used the multistep method of mutant analysis by PCR and enzyme cleavage (MAPREC). This involves conventional reverse transcription-PCR to detect OPV3, followed by a restriction digest to quantify position 472 reversion. Real-time PCR detects and quantifies nucleic acid as PCR occurs and avoids postreaction processing. The goal of this study was to compare a real-time PCR method to MAPREC. Seventy-three stool samples from Mexican OPV recipients underwent the reverse transcription-PCR step of MAPREC and real-time PCR. Real-time PCR identified 23% more OPV3-positive samples than conventional reverse transcription-PCR. When reversion was compared, the revertant proportion (RP), defined as the percentage of revertants in a sample, differed by < or =10% in 21/25 (84%) samples. The four samples differing by >10% were obtained within 5 days of OPV administration. The real-time PCR assay identified samples with an RP of > or =85% with 94% sensitivity and 86% specificity compared to MAPREC. The mean difference in RP between the two methods was 3.6% (95% confidence interval, -0.3 to 7.5%). Real-time PCR methods reliably detect OPV3, and reversion estimates correlate more consistently with MAPREC when OPV3 reversion rates are high. Detecting VAPP-related mutations by real-time PCR is rapid and efficient and can be useful in monitoring ongoing global polio eradication efforts.

  View details for DOI 10.1128/JCM.02268-06

  View details for PubMedID 17581940

• The effectiveness of state and national policy on the implementation of perinatal HIV prevention interventions AMERICAN JOURNAL OF PUBLIC HEALTH Sarnquist, C. C., Cunningham, S. D., Sullivan, B., Maldonado, Y. 2007; 97 (6): 1041-1046

  Abstract

  The 1994 and 1995 US Public Health Service Guidelines regarding HIV testing and treatment for pregnant women and the resulting 1995 California law mandating an HIV test and treatment offer to every pregnant woman aim to reduce perinatal HIV transmission. However, the effectiveness of such policies after implementation is often unclear. We analyzed the association between these policies and offers of HIV tests and treatment to HIV-infected women in California.Data from active, population-based surveillance of 496 HIV-infected women and their infants, collected from 1987 to 2002, were analyzed to compare rates of offers of HIV tests and treatment before and after 1996.We found significant increases in offers of HIV tests (P<.001) and offers of treatment (P<.001) when we compared women who delivered between 1987 and 1995 with those who delivered between 1996 and 2002. Receipt of prenatal care was the major predictor of both test and treatment offer. A significant shift in reported HIV risk factors was also evident between the 2 groups.Our findings of increased offers of HIV tests and treatment to HIV-infected pregnant women suggest that the national guidelines and the 1996 California law improved health care for these women, which may lessen the risk of perinatal HIV transmission.

  View details for DOI 10.2105/AJPH.2005.072371

  View details for PubMedID 17463383

• Disease progression among HIV-infected children who receive perinatal zidovudine prophylaxis JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES Berk, D. R., Falkovitz-Halpern, M. S., Sullivan, B., Ruiz, J., Maldonado, Y. A. 2007; 44 (1): 106-111

  Abstract

  Studies of perinatal HIV infection have reported mixed results regarding the prognosis of HIV-infected infants exposed to perinatal zidovudine prophylaxis (PZP).We have followed a population-based cohort of children with perinatal HIV infection to evaluate whether early HIV disease progression was more common among those who received PZP and whether subsequent antiretroviral therapy (ART) was less effective in preventing early disease progression.We identified 73 children with perinatal HIV infection born between 1994 and 2001 with at least 3 years of follow-up and with information concerning PZP administration. Children who received PZP started subsequent ART at an earlier age than those who did not receive PZP (median age at starting treatment: 2 months for PZP vs. 6 months for no PZP; P = 0.0002). PZP was associated with decreased early HIV progression: 21% (7 of 33) of children who received PZP progressed to a category C diagnosis by 3 years compared with 45% (18 of 40) of children who did not receive PZP (P = 0.047). Children who did not receive PZP progressed to a category C diagnosis at a younger age than children who received PZP (median: 4 vs. 11 months; P = 0.061). ART was as effective in preventing early HIV progression in children who received PZP as in children who did not receive PZP.In our population-based cohort of perinatally HIV-infected children, those who received PZP started ART at a significantly earlier age than those who did not receive PZP and also demonstrated decreased HIV disease progression by the age of 3 years.

  View details for PubMedID 17075392

• A comparison of perinatal HIV prevention opportunities for Hispanic and non-Hispanic women in California AIDS EDUCATION AND PREVENTION Kropp, R. Y., Sarnquist, C. C., Montgomery, E. T., Ruiz, J. D., Maldonado, Y. A. 2006; 18 (5): 430-443

  Abstract

  Using a semi-structured survey and convenience sample of pregnant/recently delivered Hispanic (n = 453) and non-Hispanic (n = 904) women in four California counties, this study compared rates of timely prenatal care (PNC) initiation, HIV test counseling, test offering, and test acceptance in PNC between Hispanic and non-Hispanic women. Hispanic women were less likely to report timely PNC initiation (69.3% vs. 80.4%, p < .0001), receiving test offer (69.5% vs. 76.7%, p = .002), and ever having been tested (77.3% vs. 87.9%, p < .0001) than non-Hispanic women. Hispanic women were more likely to report not knowing where to go (p = .04) and having no insurance (p < .001), transportation (p = .001), and child care (p = .007) as reasons for late PNC start. Both Hispanic and non-Hispanic women most commonly accepted a test offer for their health/health of their baby; Hispanic women were more likely to accept based on doctor/nurse recommendation (80.1% vs. 62.7%, p < .001). A quarter of Hispanic and non-Hispanic women reported they didn't feel they had a choice or that test was done automatically. Efforts to improve perinatal HIV prevention opportunities for all women in California are required. Furthermore, Hispanic women may have disparities in receipt of prenatal care and HIV test offer that need additional attention.

  View details for Web of Science ID 000241078100005

  View details for PubMedID 17067254

• Range of normal neutrophil counts in healthy Zimbabwean infants: Implications for monitoring antiretroviral drug toxicity 15th International AIDS Conference Wells, J., Shetty, A. K., Stranix, L., Falkovitz-Halpern, M. S., Chipato, T., Nyoni, N., Mateta, P., Maldonado, Y. LIPPINCOTT WILLIAMS & WILKINS. 2006: 460–63

  Abstract

  Mother-to-child HIV prevention trials in sub-Saharan Africa use the US National Institutes of Health Division of AIDS (DAIDS) grading scale to monitor hematologic toxicity. A recent study of nevirapine prophylaxis given for 6 months in breast-feeding Zimbabwean infants reported several cases of relative neutropenia in clinically well infants, raising concerns of drug toxicity. However, the DAIDS tables are based on normal blood counts for white infants, although there is evidence that black African infants may have lower absolute neutrophil counts (ANCs) than white infants. To establish normal hematologic values in black Zimbabwean infants and to quantify the apparent prevalence of relative neutropenia in this population, we evaluated HIV-uninfected healthy infants born to HIV-uninfected women at birth, 10 days, 6 weeks, 3, and 4 months of life. A physical examination and blood count were performed at each visit, and an HIV test was performed at the final visit. The ANC values were graded using the DAIDS table. A total of 145 healthy term infants satisfied the inclusion criteria. The mean ANC values for Zimbabwean infants were less than half of the corresponding standard values at all 5 time points (P < 0.0001). Using the DAIDS table in use at the time that the blood was collected, 57% of these healthy infants had relative neutropenia of any grade at birth, followed by 29% at day 10, 53% at 6 weeks, 32% at 3 months, and 37% at 4 months of life. Our data indicate that relative neutropenia exists in healthy black Zimbabwean infants. The guidelines for identifying toxicity were changed in December 2004. However, even by the new DAIDS tables, 43%, 23%, 24%, 42%, and 43% of these healthy babies had relative neutropenia at the time of the 5 visits. Future HIV prevention and treatment trials in sub-Saharan Africa should use normal hematologic values derived from African infants to avoid the overestimation of antiretroviral drug toxicity.

  View details for Web of Science ID 000239129100011

  View details for PubMedID 16810112

• Safety and immunogenicity of two live attenuated human rotavirus vaccine candidates, 116E and I321, in infants: Results of a randomised controlled trial VACCINE Bhandari, N., Sharma, P., Glass, R. I., Ray, P., Greenberg, H., Taneja, S., Saksena, M., Rao, C. D., Gentsch, J. R., Parashar, U., Maldonado, Y., Ward, R. L., Bhan, M. K. 2006; 24 (31-32): 5817-5823

  Abstract

  We evaluated safety and immunogenicity of two orally administered human rotavirus vaccine candidates 116E and I321. Ninety healthy infants aged 8 weeks received a single dose of 116E (10(5)FFu (florescence focus units)), I321 (10(5)FFu) or placebo. There were no significant differences in the number of adverse events. Fever was reported by 6/30, 1/30 and 5/30 in the 116E, I321 and placebo groups; the corresponding figures for diarrhoea were 5/30, 8/29 and 3/30. Serum IgA seroconversion rates were 73%, 39% and 20% in the 116E, I321 and placebo groups, respectively. Vaccine virus was shed on days 3, 7 or 28 in 11/30 infants of the 116E and none in the other two groups. The 116E strain is attenuated, clinically safe and highly immunogenic with a single dose.

  View details for DOI 10.1016/j.vaccine.2006.05.001

  View details for Web of Science ID 000239470000008

  View details for PubMedID 16735085

• Immunogenicity of aerosol measles vaccine given as the primary measles immunization to nine-month-old Mexican children 42nd Annual Meeting of the Infectious-Diseases-Society-of-America Wong-Chew, R. M., Islas-Romero, R., Garcia-Garcia, M. D., Beeler, J. A., Audet, S., Santos-Preciado, J. I., Gans, H., Lew-Yasukawa, L., Maldonado, Y. A., Arvin, A. M., Valdespino-Gomez, J. L. ELSEVIER SCI LTD. 2006: 683–90

  Abstract

  Aerosol measles vaccination has been found to be more immunogenic than subcutaneous administration as a booster in school aged children, and immunogenic in 12-month-old children as a primary dose. The objective of the study was to evaluate immunogenicity to aerosol measles vaccine in 9-month-old children.Nine-months-old infants received Edmonston-Zagreb measles vaccine by aerosol (10(3.58) CCID50/0.1 mL, estimated retained dose 10(2.81) CCID50 or subcutaneous route (10(4.28) CCID50/0.5 mL); cellular and humoral immunity and adverse events were assessed.Measles-specific T cell proliferative responses developed in 42% of children given aerosolized vaccine compared with 67% of those who received subcutaneous vaccine (p = 0.01); the mean stimulation index (SI) was 4.4+/-0.7 versus 6.9+/-1, respectively, (p = 0.05). Seroconversion rates were 33 and 92% after aerosol or subcutaneous immunization (p < 0.001). Among infants who developed serologic responses, measles geometric mean titers (GMT; 95% CI) by neutralizing antibody assay were 215 mIU/mL (115-400) in aerosol vaccine recipients and 411 mIU/mL (345-490) in those given subcutaneous vaccine (p = 0.06).The proportion of 9-month-old infants who developed cellular and/or humoral immunity to measles was lower in the aerosol group but measles antibody and T cell responses were comparable among those who developed measles immunity. Differences in response rates are attributable to the lower aerosol dose. Improving aerosol delivery or increasing the dose may enhance immunogenicity of primary aerosol measles vaccination in this age group.

  View details for DOI 10.1016/j.vaccine.2005.08.045

  View details for Web of Science ID 000235273900017

  View details for PubMedID 16154241

• Screening for psychological morbidity in HIV-infected and HIV-uninfected pregnant women using community counselors in Zimbabwe. Journal of the International Association of Physicians in AIDS Care (Chicago, Ill. : 2002) Stranix-Chibanda, L., Chibanda, D., Chingono, A., Montgomery, E., Wells, J., Maldonado, Y., Chipato, T., Shetty, A. K. 2005; 4 (4): 83-88

  Abstract

  To examine the prevalence of psychological morbidity in HIV-infected and uninfected pregnant women seeking antenatal care in Zimbabwe.Pregnant women were screened for psychological morbidity at the initial antenatal care visit using the 14-item Shona Symptom Questionnaire (SSQ) before voluntary HIV counseling and testing (VCT). The primary outcome measure was "cases," as determined by a SSQ score of >or= 8. Demographic characteristics and HIV status were compared between cases and noncases to determine the risk factors for psychological morbidity.Of the 437 participants, psychological morbidity was detected in 73 (17%) women before undergoing VCT. Risk factors for psychological morbidity included having a spouse older than 35 years of age. HIV infection by itself was not a risk factor for psychological morbidity for women.There is a high burden of psychological morbidity among pregnant women in Zimbabwe. Mental health services should be integrated into antenatal care to improve psychological health for all women in Zimbabwe.

  View details for PubMedID 16533796

• The feasibility of voluntary counselling and HIV testing for pregnant women using community volunteers in Zimbabwe 14th International AIDS Conference Shetty, A. K., Mhazo, M., Moyo, S., Von Lieven, A., Mateta, P., Katzenstein, D. A., Maldonado, Y., Hill, D., Bassett, M. T. ROYAL SOC MEDICINE PRESS LTD. 2005: 755–59

  Abstract

  The purpose of this pilot project was to assess the feasibility and acceptability of voluntary counselling and HIV testing (VCT) by pregnant women using community volunteers in Zimbabwe to prevent mother to child transmission (MTCT) of HIV. From July 1999 to June 2001, a short-course zidovudine (ZDV)-based perinatal HIV prevention programme was initiated in two antenatal clinics. Community volunteers, recruited from local community organizations, underwent a two-week training course in VCT, which included HIV/AIDS facts, systematic counselling approach, and practical counselling techniques using scripts and role-play. Rapid HIV testing was performed after informed consent. Lay counsellors conducted individual pre- and post-test counselling for HIV. A total of 35 women community volunteers were trained in VCT; 34 graduated and committed to work four hours per week in the clinic. Of the 6051 pregnant women presenting for antenatal clinics (ANC), 1824 (30%) underwent pre-test counselling and 1547 (26%) were tested, and 429 (28%) were HIV infected. Overall, 1283 (83%) returned for their test results including 406 (95%) of HIV-infected women. Of the 406 HIV-infected women who collected their test results, only 203 (50%) opted for ZDV prophylaxis to prevent MTCT of HIV. Over the two-year study period, two counsellors died and three sought employment at other organizations. Adherence to duty roster was 97% and no breach of confidentiality was reported. Despite many challenges, VCT delivered by community volunteers is feasible and acceptable for pregnant women aiming to reduce their risk of transmitting HIV to their infants. This programme is being implemented at several urban and rural MTCT sites in Zimbabwe and can serve as a model for other resource-poor countries.

  View details for PubMedID 16303072

• Breast-milk shedding of drug-resistant HIV-1 subtype C in women exposed to single-dose nevirapine 11th Conference on Retroviruses and Opportunistic Infections Lee, E. J., Kantor, R., Zijenah, L., Sheldon, W., Emel, L., Mateta, P., Johnston, E., Wells, J., Shetty, A. K., Coovadia, H., Maldonado, Y., Jones, S. A., Mofenson, L. M., Contag, C. H., Bassett, M., Katzenstein, D. A. UNIV CHICAGO PRESS. 2005: 1260–64

  Abstract

  Single-dose nevirapine reduces intrapartum human immunodeficiency virus 1 type (HIV-1) transmission but may also select for nonnucleoside reverse-transcriptase inhibitor (NNRTI) resistance in breast milk (BM) and plasma. Among 32 Zimbabwean women, median 8-week postpartum plasma and BM HIV-1 RNA levels were 4.57 and 2.13 log(10) copies/mL, respectively. BM samples from women with laboratory-diagnosed mastitis (defined as elevated BM Na(+) levels) were 5.4-fold more likely to have HIV-1 RNA levels above the median. BM RT sequences were not obtained for 12 women with BM HIV-1 RNA levels below the lower limit of detection of the assay used. In 20 paired BM and plasma samples, 65% of BM and 50% of plasma RT sequences had NNRTI-resistance mutations, with divergent mutation patterns.

  View details for PubMedID 16136470

• Development of candidate rotavirus vaccines derived from neonatal strains in India JOURNAL OF INFECTIOUS DISEASES Glass, R. I., Bhan, M. K., Ray, P., Bahl, R., Parashar, U. D., Greenberg, H., Rao, C. D., Bhandari, N., Maldonado, Y., Ward, R. L., BERNSTEIN, D. I., Gentsch, J. R. 2005; 192: S30-S35

  Abstract

  The need for a rotavirus vaccine in India is based on the enormous burden associated with the >100,000 deaths due to rotavirus diarrhea that occur annually among Indian children. Two rotavirus strains identified during nosocomial outbreaks of rotavirus infection in New Delhi and Bangalore, India, more than a decade ago are being developed as live oral vaccines. Infected newborns had no symptoms, shed virus for up to 2 weeks after infection, mounted a robust immune response, and demonstrated protection against severe rotavirus diarrhea after reinfection. The 2 strains are naturally occurring bovine-human reassortants. The New Delhi strain, 116E, is characterized as having a P[11],G9 genotype, and the Bangalore strain, I321, is characterized as having a P[11],G10 genotype. The strains have been prepared as pilot lots for clinical trials to be conducted in New Delhi. This unique project, which is developing a new rotavirus vaccine in India with the use of Indian strains, an Indian manufacturer, and an Indian clinical development program, aims to expedite introduction of rotavirus vaccines in India.

  View details for Web of Science ID 000231113500005

  View details for PubMedID 16088802

• Temporal trends in early clinical manifestations of perinatal HIV infection in a population-based cohort JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Berk, D. R., Falkovitz-Halpern, M. S., Hill, D. W., Albin, C., Arrieta, A., Bork, J. M., Cohan, D., Nilson, B., Petru, A., Ruiz, J., Weintrub, P. S., Wenman, W., Maldonado, Y. A. 2005; 293 (18): 2221-2231

  Abstract

  The effect of early antiretroviral therapy (ART) on the early progression of perinatal human immunodeficiency virus (HIV) infection is not well defined.To examine early disease progression and survival in a population-based cohort with perinatal HIV infection in relation to year of birth and use of ART.Retrospective study of temporal trends in early progression of perinatal HIV infection among 205 HIV-infected children in Northern California born between January 1, 1988, and December 31, 2001, and followed up through age 3 years.Prevalence of and age at progression to a first US Centers for Disease Control and Prevention category C diagnosis relative to year of birth, type of ART, and age at initiation of therapy.Of 205 children, 134 (65%) received ART and/or Pneumocystis jiroveci pneumonia prophylaxis. By age 3 years, 81 (40%) progressed to a category C diagnosis, 41 (51%) of whom died. Untreated children were significantly more likely to progress to a category C diagnosis (62% [44/71] untreated vs 28% [37/134] treated children, P<.001); none of 23 infants who received triple ART progressed to category C. However, even without triple ART, very early mono/dual ART (by age 2 months vs 3-4 months) was associated with delayed and decreased progression to category C (P = .02). Of 33 children born between January 1, 1996, and December 31, 2001, only 7 (21%) progressed to category C (P = .02 compared with 1988-1995), 6 of 7 of whom received no therapy. More recent year of birth and more advanced therapy were associated with improved survival.This population-based cohort demonstrated decreased early HIV progression and improved survival at age 3 years, associated with more advanced therapy. Although limited by small sample size, the findings suggest that very early treatment, even without triple ART, was associated with improved outcome.

  View details for PubMedID 15886377

• Unique challenges to preventing perinatal HIV transmission among Hispanic women in California: Results of a needs assessment AIDS EDUCATION AND PREVENTION Kropp, R. Y., Montgomery, E. T., Hill, D. W., Ruiz, J. D., Maldonado, Y. A. 2005; 17 (1): 22-40

  Abstract

  To identify rates and factors associated with timely prenatal care (PNC) initiation, HIV test counseling, test offering, and test offer acceptance, we conducted a semistructured survey of a convenience sample of pregnant/recently delivered Hispanic women (n=453, 418 with analyzable data) in four California counties in 2000. Only 68.4% and 43.5% of Hispanic women reported receiving an HIV test offer and counseling, respectively, though 88.8% of those offered a test accepted. After controlling for the effects of age, education, years lived in the United States, health insurance coverage, delivery status, and parity, Hispanic women who initiated prenatal care in the first trimester were 1.7 times more likely to be offered an HIV test and almost 3 times more likely to receive counseling than women with a later prenatal care start or no prenatal care. Factors associated with timely PNC initiation on multivariate analysis were private/HMO insurance (OR=10.7, p < .001), Medi-Cal insurance (OR = 4.32, p < .001), being 25-30 years old (OR = 3.0, p = .008), and completion of high school (OR = 2.07, p = .01). Key opportunities to prevent perinatal HIV transmission are being lost for Hispanic women in California. Interventions to increase timely PNC initiation, and to improve test offering by health care providers, may help to improve counseling and testing rates for this population.

  View details for Web of Science ID 000227275300003

  View details for PubMedID 15843108

• Shedding of Sabin poliovirus type 3 containing the nucleotide 472 uracil-to-cytosine point mutation after administration of oral poliovirus vaccine JOURNAL OF INFECTIOUS DISEASES Martinez, C. V., Old, M. O., Kwock, D. K., Khan, S. S., Garcia, J. J., Chan, C. S., Webster, R., Falkovitz-Halpern, M. S., Maldonado, Y. A. 2004; 190 (2): 409-416

  Abstract

  A uracil-to-cytosine point mutation at nucleotide (nt) 472 of Sabin oral poliovirus vaccine (OPV) type 3 is found in conjunction with vaccine-associated paralytic poliomyelitis (VAPP). Direct RNA extraction and mutant analysis by polymerase chain reaction and restriction enzyme cleavage were used to identify this point mutation in clinical samples. A total of 238 stool samples were obtained from 28 healthy infants for 6 weeks after OPV vaccination. More than 25% of infants shed OPV3 in the week after vaccination, with a decrease on day 6. A second wave of OPV3 shedding occurred beginning the second week after vaccination and was maintained through the end of the study period. During the first week after vaccination, the proportion of nt 472 mutants in the shed OPV3 increased from undetectable to almost 100%. During the second shedding period, the proportion of nt 472 mutants remained close to 100%. These results suggest that selective mutation drives the VAPP-associated nt 472 point mutation for OPV3 in the human gastrointestinal tract.

  View details for PubMedID 15216480

• Humoral and cell-mediated immune responses to an early 2-dose measles vaccination regimen in the United States 41st Annual Meeting of the Infectious-Diseases-Society-of-America Gans, H. A., Yasukawa, L. L., Alderson, A., Rinki, M., DeHovitz, R., Beeler, J., Audet, S., Maldonado, Y., Arvin, A. M. UNIV CHICAGO PRESS. 2004: 83–90

  Abstract

  Shifts in peak measles incidence to children <12 months old and the associated high mortality support the study of an early 2-dose measles vaccine regimen.Fifty-five infants were vaccinated with measles vaccine at age 6 (n=32) or 9 (n=23) months, followed by measles-mumps-rubella (MMR)-II vaccine at age 12 months. A control group received MMR-II only at age 12 months. Measles-specific humoral and cell-mediated immunity were evaluated before, 12 weeks after measles immunization, and 24 weeks after MMR-II.Measles-specific T cell proliferation after both doses of vaccine was equivalent, regardless of age or the presence of passive antibodies. Seroconversion rates, geometric mean titers, and the percentage of infants with antibody titers >120 mIU after the first measles vaccine were lower in infants vaccinated at age 6 months, regardless of the presence of passive antibodies, but measles humoral responses increased after the administration of MMR-II vaccine in children initially vaccinated at age 6 or 9 months.Measles vaccination elicits T cell responses in infants as young as 6 months old, which may prime the humoral response to the second dose. Initiating measles vaccination as an early 2-dose regimen results in an immunologic response that is likely to have clinical benefits in developed and developing countries.

  View details for PubMedID 15195246

• T cell immunity to measles viral proteins in infants and adults after measles immunization VIRAL IMMUNOLOGY Gans, H. A., Yasukawa, L. L., Alderson, A., Rinki, M., DeHovitz, R., Maldonado, Y., Arvin, A. M. 2004; 17 (2): 298-307

  Abstract

  Vaccination of infants against measles remains of global importance, and proposed new vaccine strategies include the use of measles proteins or synthetic peptides as immunogens. We studied cell-mediated immunity to whole measles antigen and measles proteins in immune adults and infants after measles vaccine. Further, we measured CD8+ T cell responses to peptide pools corresponding to the nucelocapsid (N) measles protein in adults given measles vaccine. Cell-mediated immune responses to three of four measles proteins were equivalent to those against whole measles antigen in immune adults. Responses to the fusion (F) protein were lower in infants compared to whole measles antigen (p < or = 0.03). Infant responses to both whole measles antigen and the F protein were lower compared with these responses in adults (p < or = 0.001). CD8+ T cell responses to N peptide pools varied, and differed between immune HLA-A2-positive individuals compared with naive and HLA-A2-negative subjects after measles vaccination. The measles-specific T cell adaptive response of infants is limited compared to adults, including responses to the F protein.

  View details for PubMedID 15279707

• Induction of cellular and humoral immunity after aerosol or subcutaneous administration of Edmonston-Zagreb measles vaccine as a primary dose to 12-month-old children JOURNAL OF INFECTIOUS DISEASES Wong-Chew, R. M., Islas-Romero, R., Garcia-Garcia, M. D., Beeler, J. A., Audet, S., Santos-Preciado, J. I., Gans, H., Lew-Yasukawa, L., Maldonado, Y. A., Arvin, A. M., Valdespino-Gomez, J. L. 2004; 189 (2): 254-257

  Abstract

  Infants were immunized by aerosol (10(3.6) plaque-forming units [pfu]/dose) or subcutaneous (sc) (10(4.27) pfu/dose) administration of Edmonston-Zagreb measles vaccine. Measles-specific T cell proliferative responses with a stimulation index of > or =3 developed in 72% of children given aerosol-administered vaccine, compared with 87% given s.c.-administered vaccine (P =.06). Seroconversion rates were 90% after aerosol-administered vaccine and 100% after s.c.-administered vaccine (P=.01), and measles geometric mean titers were 237 milli-international units (mIU) (95% confidence interval [CI], 146-385 mIU) and 487 mIU (95% CI, 390-609 mIU) in each group, respectively (P=.01). Measles-specific T and B cell responses were weaker after aerosol than after sc vaccination, indicating a need to use a higher aerosol dose to achieve optimal immunogenicity.

  View details for Web of Science ID 000188097900012

  View details for PubMedID 14722890

• Infant feeding practices of HIV-infected and uninfected women in Zimbabwe 13th International AIDS Conference GOTTLIEB, D., Shetty, A. K., Mapfungautsi, R. M., Bassett, M. T., Maldonado, Y., Katzenstein, D. A. MARY ANN LIEBERT INC. 2004: 45–53

  Abstract

  We surveyed infant feeding knowledge, attitudes, and practices in Zimbabwe to determine whether knowledge of HIV seropositivity influences infant feeding behavior. Questionnaires were administered to 97 women 1 and 4 weeks postpartum and prospective data on infant feeding practices were collected. Participants were pregnant women who consented to a HIV test. A total of 116 women participated of whom 99 women underwent voluntary HIV counseling and testing (VCT); 17 women agreed to blinded HIV testing but did not opt for VCT. The responses to questionnaires on infant feeding practices of HIV-positive and HIV-negative women who knew and did not know their HIV status at day 1 and week 4 postpartum were compared. We found that HIV-positive women who did not learn their status breastfed their infants less, introduced supplementary foods sooner, and planned to wean their babies earlier compared to other women (p = 0.005, p = NS, p= 0.02). HIV-positive women (30/97) more frequently reported a prior history of infant death and AIDS-related symptoms compared to HIV-negative women. We conclude that HIV-positive women who did not know their status made incorrect decisions with respect to infant feeding. These women may have suspected themselves to be HIV-positive and consequently underfed their infants or because these women were more symptomatic may have been less likely to breastfeed; decreased intake may increase the risk for malnutrition. Knowledge of HIV status may influence infant feeding decisions and reveal an urgent need to address infant feeding practices of pregnant women in Zimbabwe.

  View details for Web of Science ID 000188416500007

  View details for PubMedID 15006194

• Safety and Trough Concentrations of Nevirapine Prophylaxis Given Daily, Twice Weekly, or Weekly in Breast-Feeding Infants From Birth to 6 Months JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES Shetty, A. K., Coovadia, H. M., Mirochnick, M. M., Maldonado, Y., Mofenson, L. M., Eshleman, S. H., Fleming, T., Emel, L., George, K., Katzenstein, D. A., Wells, J., Maponga, C. C., Mwatha, A., Jones, S. A., Karim, S. S., Bassett, M. T. 2003; 34 (5): 482-490

  Abstract

  Despite the success of antiretroviral prophylaxis in reducing mother-to-child HIV-1 transmission, postpartum transmission through breast milk remains a problem. Antiretroviral administration to the infant during the period of breast-feeding could protect against postnatal transmission. An open-label phase 1/2 study was designed to assess the safety and trough concentrations of nevirapine (NVP) given once weekly (OW), twice weekly (TW), or once daily (OD) to HIV-exposed breast-feeding infants for 24 weeks. Following maternal dosing with 200 mg NVP orally at onset of labor, breast-feeding infants were randomized within 48 hours of birth to 1 of 3 regimens: arm 1, NVP given OW (4 mg/kg from birth to 14 days, upward arrow to 8 mg/kg from 15 days to 24 weeks), arm 2, NVP given TW (4 mg/kg from birth to 14 days, upward arrow to 8 mg/kg from 15 days to 24 weeks), and arm 3, NVP given OD (2 mg/kg from birth to 14 days, upward arrow to 4 mg/kg from 15 days to 24 weeks). Trough NVP concentrations and clinical and laboratory abnormalities were monitored. Of the 75 infants randomized (26 to OW, 25 to TW, and 24 to OD dosing), 63 completed the 32-week follow-up visit. No severe skin, hepatic, or renal toxicity related to NVP was observed. Neutropenia occurred in 8 infants. Trough NVP levels were lower than the therapeutic target (100 ng/mL) in 48 of 75 (64.0%) samples from infants in the OW arm, 3 of 65 (4.6%) samples in the TW arm, and 0 of 72 samples in the OD arm. Median (range) trough NVP concentrations were 64 ng/mL (range: <25-1519 ng/mL) with OW dosing; 459 (range: <25-1386 ng/mL) with TW dosing; and 1348 (range: 108-4843 ng/ml) with OD dosing. Our data indicate that NVP prophylaxis for 6 months was safe and well tolerated in infants. OD NVP dosing resulted in all infants with trough concentration greater than the therapeutic target and maintenance of high drug concentrations. A phase 3 study is planned to assess the efficacy of OD infant NVP regimen to prevent breast-feeding HIV-1 transmission.

  View details for PubMedID 14657758

• Measles and mumps vaccination as a model to investigate the developing immune system: passive and active immunity during the first year of life International Symposium on Protection of Newborns through Maternal Immunization Gans, H., DeHovitz, R., Forghani, B., Beeler, J., Maldonado, Y., Arvin, A. M. ELSEVIER SCI LTD. 2003: 3398–3405

  Abstract

  Evaluations of neutralizing antibody responses in 6-, 9- and 12-month-old infants given measles or mumps vaccine indicated that 6-month-old infants had diminished humoral immune responses associated with passive antibody effects, but also had an intrinsic deficiency in antiviral antibody production, which was independent of passive antibody effects. In contrast, lower neutralizing antibody titers in 9-month-olds were related only to passive antibody effects. Measles and mumps-specific T-cell proliferation and interferon-gamma (IFNgamma) production were induced by vaccination at 6, 9 or 12 months, regardless of passive neutralizing antibodies or age. These observations suggest a need to refine concepts about passive antibody interference and primary vaccine failure, taking into account the sensitization of antiviral T-cells, which occurs in the presence of passive antibodies and is observed in infants who do not develop active humoral immunity. A second dose of measles vaccine given at 12-15 months enhanced antiviral T-cell responses to measles in infants who were vaccinated at 6 or 9 months, and produced higher seroconversion rates. Since T-cell immunity is elicited under the cover of passive antibodies, the youngest infants benefit from the synergistic protection mediated by maternal antibodies and their own capacity to develop sensitized antiviral T-cells, which prime for subsequent exposures to the viral antigens. Conceptually, maternal immunization approaches with vaccines that can be given to women of child-bearing age before pregnancy, or that are safe for administration during pregnancy, should enhance passive antibody protection. Rather than being detrimental to infant adaptive immune responses, maternal vaccination can be coupled effectively with vaccine regimens that elicit priming of antiviral immune responses in infants during the first year of life.

  View details for DOI 10.1016/S0264-410X(03)00341-4

  View details for PubMedID 12850348

• Direct extraction of Sabin poliovirus genomes from human fecal samples using a guanidine thiocyanate extraction method Annual Meeting of the Society-for-Pediatric-Research Old, M. O., Martinez, C. V., Garcia, D. K., Martin, G., Chan, C., Maldonado, Y. A. ELSEVIER SCIENCE BV. 2003: 193–200

  Abstract

  To permit rapid and efficient detection of Sabin poliovirus type 3 from human fecal samples, we developed a guanidine thiocyanate (GuSCN) extraction and reverse transcriptase polymerase chain reaction (RT-PCR) method. Using 10-fold serial dilutions from stock Sabin-Leon 12 a1b poliovirus type 3 at 10(7) TCID(50) per 0.1 ml, genome was detected to a dilution of 10(3) TCID(50) per 0.1 ml. A total of 40 archived fecal samples were examined using this GuSCN extraction method followed by RT-PCR. Fourteen of 20 poliovirus type 3 tissue culture-positive specimens (70%) and two of 20 tissue culture-negative specimens (10%) were detected by GuSCN extraction and RT-PCR. All positive and negative extraction and RT-PCR controls were identified accurately. This GuSCN extraction and RT-PCR technique is rapid, inexpensive, and can be readily adapted to identify genome sequences of other enterovirus types in large numbers of fecal samples. Moreover, the GuSCN technique extracts viral RNA directly from fecal samples, allowing observation of in vivo alterations of genome sequences. Further studies are underway to examine the development of revertant point mutations in the Sabin poliovirus type 3 genome following oral administration of trivalent Sabin Oral Poliovirus Vaccine to humans.

  View details for DOI 10.1016/S0166-0934(03)00133-2

  View details for PubMedID 12798248

• Rapid flux in non-nucleoside reverse transcriptase inhibitor resistance mutations among subtype CHIV-1-infected women after single dose nevirapine 12th International HIV Drug Resistance Workshop Kantor, R., Lee, E., Johnston, E., Mateta, P., Zijenah, L., Maldonado, Y., KATZENSTEIN, D. INT MEDICAL PRESS LTD. 2003: U78–U79

  View details for Web of Science ID 000231265900090

• Preventing mother-to-child transmission of human immunodeficiency virus type 1 in resource-poor countries PEDIATRIC INFECTIOUS DISEASE JOURNAL Shetty, A. K., Maldonado, Y. 2003; 22 (6): 553–55

  View details for DOI 10.1097/00006454-200306000-00012

  View details for Web of Science ID 000183688200012

  View details for PubMedID 12799513

• Current controversies in vaccination - Vaccine safety JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Maldonado, Y. A. 2002; 288 (24): 3155-3158

  View details for PubMedID 12495396

• Group A streptococcal meningitis: Report of a case and review of literature since 1976 PEDIATRIC EMERGENCY CARE Shetty, A. K., Frankel, L. R., Maldonado, Y., Falco, D. A., Lewis, D. B. 2001; 17 (6): 430-434

  Abstract

  Group A streptococcal (GAS) invasive disease has become increasingly common in recent years. However, acute bacterial meningitis caused by this pathogen is unusual. We report a case of GAS meningitis in a previously healthy 21/2-year-old child associated with a dramatically rapid course and fatal outcome. A literature review of previously reported cases is presented. This case serves as a reminder that GAS can cause severe meningitis in otherwise healthy hosts.

  View details for Web of Science ID 000173001500007

  View details for PubMedID 11753187

• Immune responses to measles and mumps vaccination of infants at 6, 9, and 12 months 38th Annual Meeting of the Infectious-Diseases-Society-of-America Gans, H., Yasukawa, L., Rinki, M., DeHovitz, R., Forghani, B., Beeler, J., Audet, S., Maldonado, Y., Arvin, A. M. UNIV CHICAGO PRESS. 2001: 817–26

  Abstract

  Immunizing infants against measles at the youngest age possible has the potential to reduce morbidity and mortality. The ability of infants at 6, 9, or 12 months to respond to measles and mumps vaccines was evaluated by measuring T cell proliferation, interferon-gamma production, and neutralizing antibody titers before and after vaccination. Infants in all age groups had equivalent cellular immune responses to measles or mumps viruses, with or without passive antibodies when immunized. In contrast, 6-month-old infants without passive antibodies had low geometric mean titers of antibody to measles or mumps viruses and low seroconversion rates. Geometric mean titers of antibody to measles virus increased if infants were revaccinated at 12 months. Six-month-old infants had limited humoral responses to paramyxovirus vaccines, whereas cellular immunity was equivalent to that of older infants. T cell responses can be established by immunization with these live attenuated virus vaccines during the first year, despite the presence of passive antibodies.

  View details for Web of Science ID 000171228400002

  View details for PubMedID 11528592

• Risk factors for missed identification of HIV infected women and their infants Loyal, J. K., Hill, D., Sullivan, B., Ruiz, J., Maldonado, Y. A. OXFORD UNIV PRESS INC. 2001: 1223–23

  View details for Web of Science ID 000171226900818

• Developmental maturation of the immune response to measles and mumps live viral vaccines. Gans, H. A., Maldonado, Y., Yasukawa, L. L., Beeler, J., Audet, S., Forghani, B., Rinki, M. M., DeHovitz, R., Hammer, L., Arvin, A. M. OXFORD UNIV PRESS INC. 2000: 223–23

  View details for Web of Science ID 000088950900107

• Lack of definitive severe mitochondrial signs and symptoms among deceased HIV-uninfected and HIV-indeterminate children <= 5 years of age, pediatric spectrum of HIV disease project (PSD), USA 2nd Conference on Global Strategies for the Prevention of HIV Transmission from Mothers to Infants Dominguez, K., Bertolli, J., Fowler, M., Peters, V., Ortiz, I., Melville, S., Rakusan, T., Frederick, T., Hsu, H., D'Almada, P., Maldonado, Y., Wilfert, C. NEW YORK ACAD SCIENCES. 2000: 236–246

  Abstract

  In response to recent reports of mitochondrial dysfunction in HIV-uninfected infants exposed to antiretroviral (ARV) prophylaxis, the Perinatal Safety Review Working Group reviewed deaths in five large HIV-exposed perinatal cohorts in the United States to determine if similar cases of severe mitochondrial toxicity could be detected. We describe the results of this review for the PSD cohort.Hospitalization, clinic and death records for deceased HIV-uninfected and HIV-indeterminate children who were less than 5 years of age were reviewed. Standard definitions were used to classify HIV infection status and the likelihood that signs and symptoms were related to mitochondrial dysfunction. Children were classified as having signs and symptoms that were considered (1) unrelated, (2) unlikely, (3) consistent with, or (4) likely related to mitochondrial disease. SIDS deaths were put into a separate category.8,465 of 13,125 HIV-exposed children were either HIV-uninfected or HIV-indeterminate. Among the 84 deaths in the subgroup of 8,465 children, 9 were considered in Class 2 (unlikely), 4 were considered in Class 3 (consistent with), and none were considered in Class 4 (likely). 97% of those children who received ARV prophylaxis received zidovudine alone. None of the HIV-uninfected deaths were classified in 2, 3, or 4; and only one of these was exposed to ARV prophylaxis. Among the 3 HIV-indeterminate children who were classified in 3 (consistent with), 2 had no or unknown ARV exposure before 1994 when use of ZDV prophylaxis became the standard of care. Both HIV-uninfected and HIV-indeterminate children with ARV exposure or unknown exposure had lower mortality rates than children without ARV exposure.Monoprophylaxis with ZDV was not associated with higher death rates in the cohort of 8,465 children or with any findings likely consistent with mitochondrial dysfunction among the 85 deaths. Ongoing monitoring of drug safety in large multi-site prospective cohort studies of HIV-exposed children is essential in the era of highly active antiretroviral therapy.

  View details for Web of Science ID 000171939500028

  View details for PubMedID 11131710

• Lessons learned from a review of the development of selected vaccines PEDIATRICS Peter, G., des-Vignes-Kendrick, M., Eickhoff, T. C., Fine, A., Galvin, V., LEVINE, M. M., Maldonado, Y. A., Marcuse, E. K., Monath, T. P., Osborn, J. E., Macy, J., Plotkin, S., Poland, G. A., Quinlisk, M. P., Smith, D. R., Sokol, M., Soland, D. B., Whitley-Williams, P. N., Williamson, D. E., Breiman, R. F., Arvin, A., Baylor, N., Breiman, R., Clements-Mann, M. L., Couch, R., Douglas, G., Galambos, L., Gellin, B., Gershon, A., Glass, R., Gordon, L., Glode, M., Greenberg, H., Hardegree, C., Heilman, C., Hilleman, M., Jordan, W., LEVINE, M. M., MARCUSE, E., Paradiso, P., Parkman, P., Plotkin, S., Quinnan, G., Rabinovich, R., Read, L., Russell, P., Sewell, J., Shepherd, H. R., Siber, G., Soland, D., Ward, J., WHITE, J., Wright, P. 1999; 104 (4): 942-950

  View details for Web of Science ID 000082907300014

• Lessons learned from a review of the development of selected vaccines. National Vaccine Advisory Committee. Pediatrics Peter, G., des Vignes-Kendrick, M., Eickhoff, T. C., Fine, A., Galvin, V., LEVINE, M. M., Maldonado, Y. A., Marcuse, E. K., MONATH, T. P., Osborn, J. E., Plotkin, S., Poland, G. A., Quinlisk, M. P., Smith, D. R., Sokol, M., Soland, D. B., Whitley-Williams, P. N., Williamson, D. E., Breiman, R. F. 1999; 104 (4): 942-950

  Abstract

  Although the vaccine research and development network in the United States remains vibrant, its continued success requires maintaining harmonious interaction among its many components. Changing one component is likely to affect the system overall. An examination of case studies of the development of selected vaccines would allow an examination of the network as a whole. This article presents conclusions drawn from the case study review undertaken.Successful development of vaccines is a time-intensive process requiring years of commitment from a network of scientists and a continuum of regulatory and manufacturing entities. We undertook this work to shed light on how well the vaccine development system in the United States performs.The National Vaccine Advisory Committee examined the research and development pathways of several vaccines that reached licensure expeditiously (hepatitis B vaccine, Haemophilus influenzae type b conjugate vaccines); some that became licensed only after considerable delay (oral typhoid Ty21a vaccine, varicella vaccine); some that are at the point of imminent or recent licensure (reassortant Rhesus rotavirus vaccine, which was licensed by the Food and Drug Administration on August 30, 1998) or near submission for licensure (intranasal cold adapted influenza vaccine); and one for which clinical development is slow because of hurdles that must be overcome (respiratory syncytial virus vaccines).Some common themes emerged from the reviews of these vaccine "case histories": the expediting influence of a strong scientific base and rationale; the need for firm quantitation of disease burden and clear identification of target populations; the critical role played by individuals or teams who act as "champions" to overcome the inevitable obstacles; availability of relevant animal models, high-quality reagents and standardized assays to measure immune response; the absolute requirement for well designed, meticulously executed clinical trials of vaccine safety, immunogenicity, and efficacy; postlicensure measurements of the public health impact of the vaccine and a track record of the vaccine's safety and acceptance with large-scale use; and the critical need for international collaborations to evaluate vaccines against diseases of global importance that are rare in the United States (eg, typhoid fever). It was clear that the critical step-up from bench scale to pilot lots and then to large-scale production, which depends on a small group of highly trained individuals, is often a particularly vulnerable point in the development process.One fundamental lesson learned is that within the varied and comprehensive US vaccine development infrastructure, multiple and rather distinct paths can be followed to reach vaccine licensure. The National Vaccine Advisory Committee review process should be conducted periodically in the future to ascertain that the US vaccine development network, which has been enormously productive heretofore and has played a leadership role globally, is adapting appropriately to ensure that new, safe, and efficacious vaccines become available in a timely manner.

  View details for PubMedID 10506239

• The epidemiology of neonatal herpes simplex virus infections in California from 1985 to 1995 Annual Meeting on the General Clinical Research Center Gutierrez, K. M., Halpern, M. S., Maldonado, Y., Arvin, A. M. OXFORD UNIV PRESS INC. 1999: 199–202

  Abstract

  Comprehensive hospital discharge data completed by the California Office of Statewide Health Planning and Development was used to determine whether the proportion of infants

  View details for Web of Science ID 000081132100027

  View details for PubMedID 10353880

• Serum level of maternal human immunodeficiency virus (HIV) RNA, infant mortality, and vertical transmission of HIV in Zimbabwe Conference on Global Strategies for the Prevention of HIV Transmission from Mothers to Infants Katzenstein, D. A., Mbizvo, M., Zijenah, L., Gittens, T., Munjoma, M., Hill, D., Madzime, S., Maldonado, Y. UNIV CHICAGO PRESS. 1999: 1382–87

  Abstract

  Maternal human immunodeficiency virus (HIV) RNA load, vertical transmission of subtype C HIV, and infant mortality were examined in 251 HIV-seropositive women and their infants in Zimbabwe. Demographic characteristics, health and medical histories, serum HIV RNA loads, and CD4+ lymphocyte counts for mothers were examined by logistic regression analysis to determine significant risk factors and their odds ratios for transmission and infant mortality. Tenfold (1 log10) incremental increases in maternal HIV RNA were associated with a 1.9-fold increase (95% confidence interval [CI], 1.2-2.9) in transmission and a 2.1-fold increase (95% CI, 1.3-3.5) in infant mortality (P<.01). Maternal CD4 cell counts and demographic and medical characteristics were not significant predictors of transmission. However, maternal CD4 cell counts below the median (400/mm3) were significantly associated with infant mortality (P=. 035, Fisher's exact test). The maternal level of serum HIV is an important determinant of vertical transmission and infant mortality in subtype C infection in Zimbabwe.

  View details for Web of Science ID 000080561100010

  View details for PubMedID 10228058

• IL-12, IFN-gamma, and T cell proliferation to measles in immunized infants JOURNAL OF IMMUNOLOGY Gans, H. A., Maldonado, Y., Yasukawa, L. L., Beeler, J., Audet, S., Rinki, M. M., DeHovitz, R., Arvin, A. M. 1999; 162 (9): 5569-5575

  Abstract

  Measles infection in infants is associated with severe complications, and secondary infections are attributed to generalized immunosuppression. Measles binding to its monocyte receptor down-regulates IL-12 which is expected to diminish Th1-like cytokine responses, including IFN-gamma. Whether young infants can be immunized effectively against measles is an important public health issue. We evaluated Ag-specific IL-12, IFN-gamma, and T cell responses of infants at 6 (n = 60), 9 (n = 46), or 12 mo (n = 56) of age and 29 vaccinated adults. IL-12 and IFN-gamma release by PBMC stimulated with measles Ag increased significantly after measles immunization in infants. IL-12 and IFN-gamma concentrations were equivalent in younger and older infants, but IL-12 concentrations were significantly lower in infants than in adults (p = 0.04). IL-12 production by monocytes was down-regulated by measles; the addition of recombinant human IL-12 enhanced IFN-gamma production by PBMC stimulated with measles Ag, but infant T cells released significantly less IFN-gamma than adult T cells under this condition. Of particular interest, the presence of passive Abs to measles had no effect on the specific T cell proliferation or IFN-gamma production after measles stimulation. Cellular immunity to measles infection and vaccination may be limited in infants compared with adults as a result of less effective IFN-gamma and IL-12 production in response to measles Ags. These effects were not exaggerated in younger infants compared with effects in infants who were immunized at 12 mo. In summary, infant T cells were primed with measles Ag despite the presence of passive Abs, but their adaptive immune responses were limited compared with those of adults.

  View details for Web of Science ID 000079892600073

  View details for PubMedID 10228039

• Immune responses of 6, 9 and 12 month old infants immunized with measles or mumps vaccine and the effects of passive antibodies on these responses Gans, H. A., Lew-Yasukawa, L., Beeler, J., DeHovitz, R., Maldonado, Y., Arvin, A. M. NATURE PUBLISHING GROUP. 1999: 161A–161A

  View details for Web of Science ID 000079476700940

• Trends in northern California population-based regional perinatal HIV exposure and infection, 1990-1995 Hill, D., Maldonado, Y. A., Sullivan, B. INT PEDIATRIC RESEARCH FOUNDATION, INC. 1999: 163A

  View details for DOI 10.1203/00006450-199904020-00969

  View details for Web of Science ID 000079476700953

• A novel fecal extraction method to identify sabin vaccine viruses among infants receiving OPV after previous IPV administration Old, M. O., Garcia, J., Kwock, D., Martinez, C., Maldonado, Y. A. NATURE PUBLISHING GROUP. 1999: 170A–170A

  View details for Web of Science ID 000079476700996

• Patterns of health seeking behavior during episodes of childhood diarrhea: a study of Tzotzil-speaking Mayans in the highlands of Chiapas, Mexico SOCIAL SCIENCE & MEDICINE Granich, R., Cantwell, M. F., Long, K., Maldonado, Y., Parsonnet, J. 1999; 48 (4): 489-495

  Abstract

  In Chiapas, Mexico, diarrheal disease causes the majority of all deaths in children under the age of five. Treatment of childhood diarrhea may be influenced by local beliefs and cultural practices. Few studies have attempted to quantitatively evaluate health seeking behavior (HSB) for diarrheal diseases in indigenous communities, while controlling for potential confounding factors such as parental education or socioeconomic status. A rapid ethnographic survey was conducted in Nabenchauc, Chiapas, to determine hypothetical HSB patterns for each of four major types of childhood diarrhea. Additionally, we examined the actual HSB for the last episode of childhood diarrheal illness within the household. One hundred households participated in the survey; 94 households with children < 5 years old reported a mean of 1.9 diarrheal episodes during the preceding month. Households reported using a mean of 1.3 types of in-home remedies. Oral rehydration therapy (ORT) was used in <2% of the 368 HSB patterns elicited for the four types of diarrhea. HSB patterns utilized an eclectic combination of traditional, allopathic, local and distant health care options. A mean of 2.5 outside-the-home health care options were reported for each diarrheal type; the local grocery store was reported in 245 (67%) of the hypothetical HSB patterns and as a first option in 199 (54%). Maternal and/or paternal education had little impact on hypothetical HSB. Households with lower SES were more likely to report using local grocery stores as a first option and were less likely to use options outside the village. The rapid ethnographic survey approach allows for assessment of changes in the approach to health care option utilization in cultures incorporating new health care paradigms. Public health interventions targeting local stores may lead to increased use of ORT, thereby potentially reducing early morbidity and mortality due to childhood diarrhea.

  View details for Web of Science ID 000077986300005

  View details for PubMedID 10075174

• Deficiency of the humoral immune response to measles vaccine in infants immunized at age 6 months JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Gans, H. A., Arvin, A. M., Galinus, J., Logan, L., DeHovitz, R., Maldonado, Y. 1998; 280 (6): 527-532

  Abstract

  Measles causes serious morbidity in infants, with the highest risk among those who are 6 to 12 months of age. In the United States, measles vaccine has been given at age 12 to 15 months to minimize interference by passive antibodies and to achieve the high seroprevalence required for herd immunity. Infants of mothers with vaccine-induced immunity may lose passively acquired antibodies before 12 months, leaving them susceptible to measles infection.To assess the immunogenicity of measles vaccine in infants younger than 12 months.Cohort study conducted before and after measles immunization.Pediatric clinic in Palo Alto, Calif.Infants 6 (n = 27), 9 (n = 26), and 12 (n = 34) months of age were enrolled; 72 provided both initial and follow-up samples.Evaluation of immunogenicity before and 12 weeks after measles vaccination, including measles neutralizing antibody titers, measles-specific T-cell proliferation, and cytokine profiles.Measles neutralizing antibodies were present before vaccination in 52% (12/23), 35% (7/20), and 0% (0/22) of 6-, 9-, and 12-month-old infants, respectively. In the absence of detectable passive antibodies, geometric mean titers after vaccination were significantly lower in 6-month-old infants compared with 9-month-old infants (27 vs 578, P = .01) and 12-month-old infants (27 vs 972, P=.001). The seroconversion rate, defined as a 4-fold rise in antibody titer, in these 6-month-old infants was only 67%, and only 36% of these infants achieved seroprotective neutralizing antibody titers of 120 or higher after vaccination compared with 100% of 9- and 12-month-old infants lacking detectable passive antibody prior to vaccination. T-cell proliferation and cytokine responses to measles did not differ with age.Humoral immunity was deficient in 6-month-old infants given measles vaccine, even in the absence of detectable passively acquired neutralizing antibodies. Comparison of their responses with those of 9- and 12-month-old infants indicates that a developmental maturation of the immune response to measles may occur during the first year of life, which affects the immunogenicity of measles vaccine.

  View details for Web of Science ID 000075244900028

  View details for PubMedID 9707142

• Population-based prevalence of symptomatic and asymptomatic astrovirus infection in rural Mayan infants 26th Interscience Conference on Antimicrobial Agents and Chemotherapy Maldonado, Y., Cantwell, M., Old, M., Hill, D., Sanchez, M. D., Logan, L., Millan-Velasco, F., Valdespino, J. L., Sepulveda, J., Matsui, S. UNIV CHICAGO PRESS. 1998: 334–39

  Abstract

  Symptomatic and asymptomatic astrovirus infection was prospectively determined in a 3-year birth cohort of Mayan infants. Stool samples from 271 infants and 268 older siblings were tested for astrovirus, adenovirus 40/41, rotavirus and Salmonella, Shigella and Campylobacter species. Concurrent diarrhea, vomiting, fever, or anorexia were noted. Astrovirus was detected in 164 infants (61%) and 20 siblings (7%). Rotavirus (4%) and adenovirus 40/41 (13%) were isolated less frequently. Of all diarrheal episodes reported at a visit, 26% (78/305) were associated with astrovirus; 17% (78/452) of astrovirus infections were associated with diarrhea and 9% with other symptoms. Only diarrhea was associated with astrovirus infection (odds ratio, 1.4; 95% confidence interval [CI], 1.07-1.92; P = .01). Of infants with astrovirus, 70% shed at multiple visits over a period of 2-17 weeks (median, 5). The point prevalence of astrovirus infection was significantly higher among infants than siblings (relative risk, 6.18; 95% CI, 3.93-9.72; P < .0001, chi2). Astrovirus was identified throughout the year, peaked in March and May, and decreased in September. In this population, astrovirus was the most common enteric pathogen isolated; symptomatic infection was prevalent among infants.

  View details for Web of Science ID 000075153000007

  View details for PubMedID 9697712

• Mortality in the first 2 years among infants born to human immunodeficiency virus-infected women in Harare, Zimbabwe 4th Conference on Retroviruses and Opportunistic Infections Zijenah, L., Mbizvo, M. T., Kasule, J., Nathoo, K., Munjoma, M., Mahomed, K., Maldonado, Y., Madzime, S., Katzenstein, D. OXFORD UNIV PRESS INC. 1998: 109–13

  Abstract

  Transmission of human immunodeficiency virus (HIV) and mortality was studied among infants of infected women in Zimbabwe. Of 367 infants born to HIV-infected women, 72 (19.6%) died compared with 20 (5.4%) of 372 infants of uninfected women (P < .01). Infection by HIV DNA polymerase chain reaction among infants who survived >7 days and died within 2 years could be assessed in 87% (58/67) of infants of infected women and 83% (5/6) of infants of uninfected women; transmission occurred in 40 of 58 infants. Among 27 infected infants tested at birth, 19 (70%), 5 (19%), and 3 (11%) were apparently infected via in utero, intrapartum or early postpartum, and late postpartum transmission, respectively. The majority of HIV-infected infants who died in the first 2 years of life were likely to have acquired in utero infection.

  View details for Web of Science ID 000074357900014

  View details for PubMedID 9652429

• Pneumocystis carinii pneumonia prophylaxis and early clinical manifestations of severe perinatal human immunodeficiency virus type 1 infection XIth International Conference on AIDS Maldonado, Y. A., Araneta, R. G., Hersh, A. L. LIPPINCOTT WILLIAMS & WILKINS. 1998: 398–402

  Abstract

  Some children with perinatal HIV infection develop early progression to severe symptoms (Category C) within the first 4 years of life. Prophylactic therapy with trimethoprim-sulfamethoxazole (TMP/SMX) may affect progression by decreasing the incidence of Pneumocystis carinii pneumonia (PCP).HIV progression to Category C in the first 3 years of life was retrospectively analyzed in a population-based cohort of children with perinatal HIV infection followed for > or = 3 years from birth. Time to development of Category C and clinical patterns of new Category C diagnoses were examined in relation to patterns of PCP prophylaxis before diagnosis.Fifty-eight of 147 children developed 67 initial category C diseases by 3 years of age: PCP (n=24), encephalopathy (n=22), other opportunistic infections (n=19) and wasting (n=2). Before diagnosis therapy included TMP/ SMX and zidovudine (ZDV) (n=11), TMP/SMX alone (n=7), ZDV alone (n=1) and neither (n= 39). The probability of developing a Category C diagnosis after 2 years was significantly lower among children who received TMP/SMX compared with those who did not (29%, TMP/SMX vs. 45%, no TMP/SMX; 30%, TMP and ZDV vs. 45%, no therapy; P < 0.01). The frequency of PCP was significantly lower and that of HIV encephalopathy was significantly higher among children receiving TMP/SMX +/- ZDV before Category C diagnosis than among children receiving neither.In this study PCP prophylaxis was associated with longer time to Category C diagnoses in the first 3 years of life. This association was related to a decreased incidence of PCP and an increased incidence of encephalopathy as the first Category C diagnosis among children who received TMP/SMX.

  View details for Web of Science ID 000073634500009

  View details for PubMedID 9613653

• Neutrophil CD11b expression as a diagnostic marker for early-onset neonatal infection JOURNAL OF PEDIATRICS Weirich, E., Rabin, R. L., Maldonado, Y., Benitz, W., Modler, S., Herzenberg, L. A., Herzenberg, L. A. 1998; 132 (3): 445-451

  Abstract

  To determine whether neutrophil surface expression of CD11b predicts early-onset infection or suspected infection in at-risk infants.CD11b expression on peripheral blood neutrophils was determined by flow cytometry of whole blood samples. Blood (0.1 ml) was obtained from a convenience sample of at-risk infants admitted to the neonatal intensive care unit, stained with antibodies detecting CD11b and CD15, chilled, and analyzed within 8 hours. Blood for culture, blood counts, and C-reactive protein (CRP) determination was obtained simultaneously. Subjects were grouped on the basis of culture results and clinical signs, and investigators were blinded to CD11b level.Of 106 subjects, seven had positive bacterial or viral cultures ("confirmed infection"), 17 had clinical signs of infection but negative cultures ("suspected infection"), and 82 had negative cultures and no clinical signs ("no infection"). Neutrophil CD11b was elevated in all infants with confirmed infection, 94% with suspected infection, and none with no infection. The negative and positive predictive values, sensitivity, and specificity were 100%, 99%, 96%, and 100%, respectively, for diagnosis of neonatal infection at initial evaluation. CD11b levels correlated with peak CRP (r2 = 0.76, p < 0.0001); however, CD11b was elevated at the time of admission in all five infants with proven bacterial infection, whereas CRP was normal until the second day in the neonatal intensive care unit in three of these five. Both infants with positive viral cultures had elevated CD11b, but the CRP levels remained within normal limits. The negative predictive value of neutrophil CD11b for identifying suspected or confirmed infection was 99%.This assay for neutrophil CD11b is a promising test for exclusion of early-onset neonatal infection. If validated prospectively, this assay may reduce hospital and antibiotic use in the population of neonates at risk for early-onset infection.

  View details for Web of Science ID 000072877800018

  View details for PubMedID 9544899

• Development of chemiluminescent probe hybridization, RT-PCR and nucleic acid cycle sequencing assays of Sabin type 3 isolates to identify base pair 472 Sabin type 3 mutants associated with vaccine associated paralytic poliomyelitis JOURNAL OF VIROLOGICAL METHODS Old, M. O., LOGAN, L. H., Maldonado, Y. A. 1997; 68 (2): 109-118

  Abstract

  Sabin type 3 polio vaccine virus is the most common cause of poliovaccine associated paralytic poliomyelitis. Vaccine associated paralytic poliomyelitis cases have been associated with Sabin type 3 revertants containing a single U to C substitution at bp 472 of Sabin type 3. A rapid method of identification of Sabin type 3 bp 472 mutants is described. An enterovirus group-specific probe for use in a chemiluminescent dot blot hybridization assay was developed to identify enterovirus positive viral lysates. A reverse transcription-polymerase chain reaction (RT-PCR) assay producing a 319 bp PCR product containing the Sabin type 3 bp 472 mutation site was then employed to identify Sabin type 3 isolates. Chemiluminescent nucleic acid cycle sequencing of the purified 319 bp PCR product was then employed to identify nucleic acid sequences at bp 472. The enterovirus group probe hybridization procedure and isolation of the Sabin type 3 PCR product were highly sensitive and specific; nucleic acid cycle sequencing corresponded to the known sequence of stock Sabin type 3 isolates. These methods will be used to identify the Sabin type 3 reversion rate from sequential stool samples of infants obtained after the first and second doses of oral poliovirus vaccine.

  View details for Web of Science ID A1997YB42500001

  View details for PubMedID 9389400

• Host and viral factors affecting the decreased immunogenicity of Sabin type 3 vaccine after administration of trivalent oral polio vaccine to rural Mayan children 26th Interscience Conference on Antimicrobial Agents and Chemotherapy Maldonado, Y. A., PENACRUZ, V., Sanchez, M. D., Logan, L., Blandon, S., Cantwell, M. F., Matsui, S. M., MILLANVELASCO, F., Valdespino, J. L., Sepulveda, J. UNIV CHICAGO PRESS. 1997: 545–53

  Abstract

  Factors affecting immunogenicity of the first 2 doses of oral poliovirus vaccine (OPV) among unimmunized Mayan infants were prospectively evaluated. The relative impact of multiple variables, including mass or routine vaccination, concurrent enteric bacterial (salmonella, shigella, and campylobacter) and viral (adenovirus 40/41, astrovirus, nonpolio enteroviruses, and rotavirus) infections, interference among Sabin vaccine viruses, and preexisting poliovirus antibodies were studied. Sera were available from 181 infants after 2 OPV doses. Seroresponses were 86% to Sabin type 1, 97% to Sabin type 2, and 61% to Sabin type 3 vaccines. Mass versus routine vaccination and preexisting poliovirus antibodies did not affect immunogenicity. By multiple logistic regression analysis, fecal shedding of homologous Sabin strains was associated with increased seroresponses to all Sabin types, especially to Sabin type 3. Decreased OPV immunogenicity was primarily attributable to interference of Sabin type 3 by Sabin type 2. OPV formulations with higher doses of Sabin type 3 could improve immunogenicity among infants in developing countries.

  View details for Web of Science ID A1997WK41100006

  View details for PubMedID 9041324

• Clinical and laboratory characteristics of a large cohort of symptomatic, human immunodeficiency virus-infected infants and children PEDIATRIC INFECTIOUS DISEASE JOURNAL Englund, J. A., Baker, C. J., Raskino, C., McKinney, R. E., Lifschitz, M. H., Petrie, B., Fowler, M. G., Connor, J. D., Mendez, H., ODonnell, K., Wara, D. W., Shliozberg, J., Shearer, W. T., STECHENBERG, B., BORKOWSKY, W., Bonaforte, R. J., Cooper, E. R., Wiznia, A., Toltzis, P., Israele, V., VANDYKE, R. B., YOGEV, R., Starr, S., Oleske, F., Frenkel, L., MCINTOSH, K., Montgomery, M., Petru, A., Squires, J. E., Wade, N., Moore, E. C., Rakusan, T. A., Baker, R. C., Brady, M. T., Pildes, R. S., Cervia, J. S., Wilfert, C., Nesheim, S., Bellanti, J. A., Keller, M., Abrams, E. J., Dossett, J. H., Rana, S. R., TISHLER, D. M., Nicholas, S. W., Lambert, J. S., Wong, V., Gupta, A., Deveikis, A., Kovacs, A., Johnson, G., Bamji, M., Sacks, H. S., Pahwa, S., GarciaRias, D., Flynn, C., Philipp, C. S., Jimenez, E., Bonagura, V. R., Shenap, J. L., Grieco, M. H., LISCHNER, H., MINNEFOR, A. B., Maldonado, Y., Nachman, S. A., Fikrig, S., Weiner, L. B., Levin, M., Gershon, A. A., Bryson, Y., Spector, S., Diaz, C., Reichman, R. R., Robinson, J., Luzuriaga, K., Crain, M. J., Lim, W., Rich, K., Vink, P. E., Doyle, M. G., Scott, G. B., Munoz, J., Andiman, W. A., BEHRMAN, R., Hetherington, S., McLaren, C., Millison, K., Moye, J., Nozyce, M., Pearson, D. A., Purdue, L., Schoenfeld, D., Scott, G., Spector, S. A. 1996; 15 (11): 1025-1036

  View details for Web of Science ID A1996VT45000010

• Comparison of T-cell responses to measles antigen in infants immunized at 6, 9, and 12 months of age. Gans, H., Galinus, J., DeHovitz, R., Arvin, A., Maldonado, Y. OXFORD UNIV PRESS INC. 1996: 269–69

  View details for Web of Science ID A1996VN24600315

• Natural history of human immunodeficiency virus disease in perinatally infected children: An analysis from the pediatric spectrum of disease project PEDIATRICS Barnhart, H. X., Caldwell, M. B., Thomas, P., Mascola, L., Ortiz, I., Hsu, H. W., Schulte, J., Parrott, R., Maldonado, Y., Byers, R., STECHENBERG, B., MCINTOSH, K., Pelton, S., Meissner, C., Tobin, S., Pasternack, M., Sullivan, J., Brunell, P., Berkowitz, C., Ewing, N., Kovacs, A., Church, J., Taylor, S., Deveikis, A., Bryson, Y., Petru, A., Prober, C., Wara, D., Rubinstein, A., Lambert, G., Stein, R., Champion, S., Mendez, H., Litman, N., Futterman, D., Cervia, J., Rakusan, T., Reid, Y., Fomafod, A., Kline, M., Squires, J., Doran, T., GarciaTrias, D., Julia, J. V., Mendez, I., Diaz, C. 1996; 97 (5): 710-716

  Abstract

  To describe the progression of human immunodeficiency virus (HIV) disease through clinical stages from birth to death among a large number of perinatally infected children.The Pediatric Spectrum of Disease (PSD) project, coordinated by the Centers for Disease Control and Prevention (CDC), has conducted active surveillance for HIV disease since 1988 in seven geographic regions. PSD data are collected from medical and social service records every 6 months through practitioners at each participating hospital clinic. We analyzed data from perinatally HIV-infected children born between 1982 and 1993. The natural history of HIV disease was divided into five progressive stages using the clinical categories in the CDC 1994 pediatric HIV classification system: stage N, no signs or symptoms; stage A, mild signs or symptoms; stage B, moderate signs or symptoms; stage C, severe signs or symptoms; and stage D, death. A five-stage Markov model was fitted to the PSD data. To compare the estimates from the PSD project with the published estimates, we also fitted an alternative Markov model using acquired immunodeficiency syndrome (AIDS; 1987 case definition) in place of stage C and also calculated standard Kaplan-Meier estimates.A total of 2148 perinatally HIV-infected children were included in the analysis. The estimated mean times spent in each stage were: N, 10 months; A, 4 months; B, 65 months; and C, 34 months. We estimated that a child born with HIV infection has a 50% (95% confidence interval [CI], 40%-60%) chance of severe signs or symptoms developing by 5 years of age and a 75% (95% CI, 68%-82%) chance of surviving to 5 years of age. For a child in stage B, there is a 60% (95% CI, 49%-71%) chance of severe signs or symptoms developing within the next 5 years and a 65% (95% CI, 56%-73%) chance of surviving 5 more years. The estimated mean time from birth to stage C was 6.6 (95% CI, 5.7-7.5) years, and the estimated mean survival time from birth was 9.4 (95% CI, 8.1-10.7) years. From the alternative Markov model, the estimated mean time from birth to AIDS was 4.8 (95% CI, 4.5-5.2) years.Markov modeling using the revised pediatric classification system allowed us to describe the natural history of HIV disease in children before diagnosis of AIDS. On average, children progress to moderate symptoms in the second year of life and then remain moderately symptomatic for more than half of their expected lives, underscoring their need for clinical care before the onset of AIDS. The results from the Markov model are useful in family counseling, health care planning, and clinical trial designs.

  View details for Web of Science ID A1996UH75800018

  View details for PubMedID 8628612

• Disease patterns and survival after acquired immunodeficiency syndrome diagnosis in human immunodeficiency virus-infected children PEDIATRIC INFECTIOUS DISEASE JOURNAL Morris, C. R., ArabaOwoyele, L., Spector, S. A., Maldonado, Y. A. 1996; 15 (4): 321-328

  Abstract

  The clinical manifestations of HIV infection in children involve a broad spectrum of conditions ranging from mild symptoms to AIDS. Knowledge of the disease and survival patterns of these children are needed to plan for future needs and develop baseline information to evaluate newer prophylactic or therapeutic management options.To identify AIDS-defining conditions and estimate post-AIDS diagnosis survival among HIV-infected children.Disease patterns and survival after the diagnosis of AIDS-defining conditions were studied in 126 children who were identified through a multisite university-based active surveillance system in California from January, 1989, through August, 1993. Hospital medical records were periodically reviewed and data were abstracted onto standardized forms designed for pediatric HIV surveillance. We determined the length of survival between AIDS diagnosis and death and evaluated the impact of disease patterns on survival using Kaplan-Meier's product-limit method and Cox proportional hazards regression.The median age at diagnosis was 13 months for children with perinatally acquired infection and 101.5 months for children infected through other routes of transmission. Pneumocystis carinii pneumonia and lymphoid interstitial pneumonia were the most common AIDS-defining conditions among perinatal cases, whereas the disease patterns observed among nonperinatal cases were more varied. The median postdiagnosis survival for the cohort was 26 months.Survival time did not differ significantly by race/ethnicity, sex or route of transmission. Respiratory candidiasis and wasting syndrome had significant negative impact on survival but P. carinii pneumonia was not associated with shorter survival. Zidovudine or other antiviral therapies was associated with increased survival.

  View details for Web of Science ID A1996UE89200007

  View details for PubMedID 8866801

• EARLY LOSS OF PASSIVE MEASLES ANTIBODY IN INFANTS OF MOTHERS WITH VACCINE-INDUCED IMMUNITY PEDIATRICS Maldonado, Y. A., Lawrence, E. C., DeHovitz, R., Hartzell, H., Albrecht, P. 1995; 96 (3): 447-450

  Abstract

  Maternally derived passive measles antibody may interfere with vaccine-induced immunity in infants less than 12 months of age. However, early loss of passive measles antibody may occur in infants of women who received measles vaccine because measles vaccine induces lower antibody titers than does natural infection.Persistence of passive neutralizing measles antibody was studied longitudinally in a group of normal infants as a function of maternal measles titer at birth and maternal date of birth. Maternal serum and cord blood specimens were tested from 162 women and their newborns, from 51 of these infants at 9 months of age and from 63 at 12 months of age.Seventy-one percent of sera from 9-month-old infants (36 of 51, 95% confidence interval 68% to 84%) and 95% of samples from 12-month-old infants (60 of 63, 95% confidence interval 89% to 101%) had no detectable neutralizing measles antibody. Measles geometric mean titers were significantly higher at delivery in mothers whose infants were seropositive at 9 and 12 months compared with mothers whose infants were seronegative at 9 and 12 months. All infants with detectable measles antibody at 9 or 12 months had mothers born before 1963, before the vaccine era, and both material and cord blood measles geometric mean titers decreased significantly with decreasing maternal age.Persistence of passive measles antibody is uncommon by 12 months of age; earlier antibody loss is related to lower maternal age and maternal measles titer.

  View details for Web of Science ID A1995RT95400007

  View details for PubMedID 7651776

• ALTERED REPRESENTATION OF NAIVE AND MEMORY CD8 T-CELL SUBSETS IN HIV-INFECTED CHILDREN JOURNAL OF CLINICAL INVESTIGATION Rabin, R. L., Roederer, M., Maldonado, Y., Petru, A., Herzenberg, L. A., Herzenberg, L. A. 1995; 95 (5): 2054-2060

  Abstract

  CD8 T cells are divided into naive and memory subsets according to both function and phenotype. In HIV-negative children, the naive subset is present at high frequencies, whereas memory cells are virtually absent. Previous studies have shown that the overall number of CD8 T cells does not decrease in HIV-infected children. In studies here, we use multiparameter flow cytometry to distinguish naive from memory CD8 T cells based on expression of CD11a, CD45RA, and CD62L. With this methodology, we show that within the CD8 T cell population, the naive subset decreases markedly (HIV+ vs. HIV-, 190 vs. 370 cells/microliter; P < or = 0.003), and that there is a reciprocal increase in memory cells, such that the total CD8 T cell counts remained unchanged (800 vs. 860 cells/microliter; P < or = 0.76). In addition, we show that for HIV-infected children, the naive CD8 T cell and total CD4 T cell counts correlate (chi 2 P < or = 0.001). This correlated loss suggests that the loss of naive CD8 T cells in HIV infection may contribute to the defects in cell-mediated immunity which become progressively worse as the HIV disease progresses and CD4 counts decrease.

  View details for Web of Science ID A1995QW20500014

  View details for PubMedID 7738172

  View details for PubMedCentralID PMC295792

• Factors associated with early clinical recognition of children with perinatal human immunodeficiency virus infection. Northern California Pediatric HIV Consortium. journal of infectious diseases Maldonado, Y. A., Wang, N. E., Caldwell, B. 1995; 171 (3): 689-692

  Abstract

  Surveillance of children born to women with human immunodeficiency virus (HIV) infection at five pediatric regional centers assessed times and patterns of clinical recognition in these children. Regional HIV seroprevalences among childbearing women were used to assess the proportion of identified children born to HIV-infected women. In total, 415 children with perinatal HIV exposure were identified. Early age at first HIV evaluation was significantly associated with maternal intravenous drug use (3.2 vs. 7.2 months for other or unknown maternal risk, P = .01), birth county with population > 500,000 (3.5 vs. 8.2 months for population < or = 500,000, P = .003), and hospital with routine HIV screening of pregnant women (0.1 vs. 8.8 months for no screening, P = .006). Race did not correlate with age at first evaluation. Using maternal HIV seroprevalence rates for 1988-1991, 34%-50% of the expected number of infants born to HIV-infected women were in clinical care. Perception of increased maternal risk for HIV infection was associated with early clinical recognition of infants of HIV-infected women.

  View details for PubMedID 7876619

• GLUTATHIONE CONCENTRATION IS DECREASED IN RBC AND T-CELLS OF INFANTS AND CHILDREN MOST AFFECTED BY HIV RABIN, R. L., ROEDERER, M., MALDONADO, Y. A., HERZENBERG, L. A., HERZENBERG, L. A. MARY ANN LIEBERT INC PUBL. 1994: S38

  View details for Web of Science ID A1994PF06600074

• GLUTATHIONE CONCENTRATION IS DECREASED IN RBC AND T-CELLS OF INFANTS AND CHILDREN MOST AFFECTED BY HIV RABIN, R. L., ROEDERER, M., MALDONADO, Y. A., HERZENBERG, L. A., HERZENBERG, L. A. MARY ANN LIEBERT INC PUBL. 1994: S27

  View details for Web of Science ID A1994PF06600037

• EFFECTS OF HUMAN-IMMUNODEFICIENCY-VIRUS (HIV) EXPOSURE AND INFECTION ON PLASMA GLUTATHIONE STATUS IN CHILDREN SMITH, C. V., ROGERS, L. K., RABIN, R. L., MALDONADO, Y. A., HERZENBERG, L. A., HERZENBERG, L. A., PETRU, A. WILLIAMS & WILKINS. 1994: A196

  View details for Web of Science ID A1994NG77901160

• SEROPREVALENCE OF HERPES-SIMPLEX VIRUS-INFECTIONS AMONG POSTPARTUM WOMEN FROM A RURAL-COMMUNITY IN SOUTHERN MEXICO Gadea, J. R., Bernal, M., Yasukawa, L. L., Tran, C., Halperin, D., Prober, C. G., Maldonado, Y. A. SLACK INC. 1994: A85–A85

  View details for Web of Science ID A1994MR21400457

• BIOLOGIC, FOSTER, AND ADOPTIVE PARENTS - CAREGIVERS OF CHILDREN EXPOSED PERINATALLY TO HUMAN-IMMUNODEFICIENCY-VIRUS IN THE UNITED-STATES PEDIATRICS Caldwell, M. B., Mascola, L., Smith, W., Thomas, P., Hsu, H. W., Maldonado, Y., Parrott, R., Byers, R., Oxtoby, M. 1992; 90 (4): 603-607

  Abstract

  Children born to human immunodeficiency virus (HIV)-infected mothers often do not live with a biologic parent because of drug use, illness, or death of the mother. Public health officials need to know the number and proportion of children who will require care by someone other than a biologic parent (alternative care giver). The Pediatric Spectrum of Disease project, conducted in six different geographic regions in the United States, assesses issues specific to HIV in children. Among the information being collected in this study are data regarding the primary care giver. Of 1683 children born to HIV-infected mothers and enrolled through 1990, 55% (937) were living with a biologic parent, 10% (169) with another relative, 28% (455) were in foster care, 3% (55) had been adopted, and 4% (67) lived in group settings or with other care givers. In all locations and for all racial/ethnic groups, children of mothers who used intravenous drugs were more likely to be living with an alternative care giver than were children of mothers who had not used intravenous drugs (odds ratio 4.15). However, there were striking variations by study location (odds ratio range 1.4 to 7.2). The data suggest that maternal drug use may be the most important factor determining whether a child lives with a biologic parent and that there are also regional differences in alternative care placement.

  View details for Web of Science ID A1992JT86300018

  View details for PubMedID 1408516

• ROTAVIRUS BAILLIERES CLINICAL GASTROENTEROLOGY Maldonado, Y. A., Yolken, R. H. 1990; 4 (3): 609-625

  Abstract

  Since their discovery in the 1970s, the human rotaviruses have been recognized as the most important cause of acute infectious gastroenteritis among infants and children worldwide. Rotavirus has been found to infect almost all mammalian and avian species tested, and is primarily a disease of the young. In humans, rotavirus is the most frequent gastrointestinal pathogen in infants and children less than 2 years of age. In developing countries, the attack rate peaks at 6 months of age, whereas in developed areas of the world the virus is most commonly found among children 6-12 months of age. Rotavirus displays a marked seasonality in temperate climates, with the number of cases peaking in the colder winter months. In tropical climates, this seasonality is not as apparent, and infection may occur year round. Symptoms of rotavirus infection are non-specific and include vomiting and diarrhoea, occasionally accompanied by a low grade fever. Dehydration is more common with rotavirus infection than with most bacterial pathogens, and is the most common cause of death related to rotavirus infection. Treatment is non-specific and includes the use of oral rehydration therapy, especially in developing countries where malnutrition is common. Strategies for the prevention of rotavirus infection are dependent on advances in the understanding of the molecular biology of the rotavirus. The genetic structure of the virus has been extensively studied, and a number of the structural proteins have been identified. The neutralization antigens, located on VP4 and VP7, may be important in conferring immunity to rotavirus in vivo. Two animal-derived and several reassortant rotavirus vaccines are currently being evaluated in field studies, and a number of other candidate vaccines are being tested in vitro and in animal studies.

  View details for Web of Science ID A1990EN54900003

  View details for PubMedID 1962726

• EPIDEMIOLOGY AND POTENTIAL METHODS FOR PREVENTION OF NEONATAL INTESTINAL VIRAL-INFECTIONS REVIEWS OF INFECTIOUS DISEASES Yolken, R. H., Maldonado, Y., Kinney, J., VONDERFECHT, S. 1990; 12: S421-S427

  Abstract

  Viral infections of the gastrointestinal tract remain a major problem during the neonatal period. In addition to causing acute diarrhea, rotaviruses and other enteric viruses may be involved in the pathogenesis of necrotizing enterocolitis and other neonatal enteric diseases. There are several potential methods for the prevention and treatment of gastrointestinal viral infections. Antiviral immunoglobulins might be used to inhibit intestinal viral replication. Since only small concentrations of serum immunoglobulins are present at mucosal surfaces, oral administration of immunoglobulins might be utilized to maximize antiviral efficacy. Alternatively, inhibitors of specific glycoproteins of virus-cell binding might be used to prevent the productive infection of intestinal epithelial cells. In addition, since many enteric viruses require proteolytic enzymes for protein cleavage, protease inhibitors may prove effective for inhibition of intestinal viral replication. At this time, these methods have proven useful for the inhibition of rotavirus infection in experimental animals. The successful application of these and other methods for the prevention of enteric infections in humans might substantially reduce the morbidity and mortality associated with enteric diseases in high-risk neonates.

  View details for Web of Science ID A1990DG33700006

  View details for PubMedID 2194268

• EPITOPE-SPECIFIC IMMUNE-RESPONSES TO ROTAVIRUS VACCINATION GASTROENTEROLOGY Shaw, R. D., Fong, K. J., Losonsky, G. A., LEVINE, M. M., Maldonado, Y., Yolken, R., Flores, J., KAPIKIAN, A. Z., Vo, P. T., Greenberg, H. B. 1987; 93 (5): 941-950

  Abstract

  Rotavirus gastroenteritis is a leading cause of infant mortality in developing countries and an important cause of morbidity in children under 2 yr of age in the United States. Vaccine programs have evaluated animal rotavirus strains that are attenuated in humans but antigenically similar to some human strains. Whether a single vaccine strain can elicit protective immunity in humans to rotaviruses of the same or different serotypes is an important question in determining vaccine efficacy. We used characterized serotype-specific monoclonal antibodies directed at VP7 in a competitive solid-phase immunoassay to measure epitope-specific immune responses to serotypes 1, 2, and 3 in sera of children who received a candidate serotype-3 rotavirus vaccine. Antibodies to serotype 3 were detected in 72% of sera samples, and to serotype 1 and 2 in only 11% each. Also, a VP3-specific monoclonal antibody which neutralizes three serotypically distinct strains of rotavirus was used to detect the presence of similar antibodies in 56% of the test sera. This finding suggests a mechanism of heterotypic immunity.

  View details for Web of Science ID A1987K557000004

  View details for PubMedID 2443417

• SAFETY AND IMMUNOGENICITY OF BOVINE ROTAVIRUS VACCINE RIT-4237 IN 3-MONTH-OLD INFANTS JOURNAL OF PEDIATRICS Maldonado, Y., HESTVIK, L., Wilson, M., Townsend, T., OHARE, J., Wee, S., Yolken, R. 1986; 109 (6): 931-935

  Abstract

  To assess the safety and immunogenicity of bovine rotavirus vaccine, we administered attenuated strain RIT 4237 to 54 inner-city infants randomized to one of three groups in a double-blind fashion to receive a dose at 3 and 5 months of age of either placebo, vaccine virus at 10(7) TCID50/ml, or vaccine virus at 10(8) TCID50/ml. Vaccination began in early fall 1984, and continued through spring 1985. Forty-nine infants received one dose of vaccine or placebo; 43 received both doses of vaccine or placebo. At 2 and 3 months after vaccination, homologous geometric mean neutralizing antibody titers were significantly higher in children who received either dose of vaccine compared with placebo recipients. Cumulative seroconversion to bovine rotavirus after either dose of vaccine virus was 87% at 6 months of age. Seroconversion was significantly higher (P less than 0.01) in both vaccine groups compared with the placebo group. No ill effects were associated with vaccine administration. RIT 4237 vaccine appears to be safe and immunogenic when administered to young infants living in the United States.

  View details for Web of Science ID A1986F117800003

  View details for PubMedID 3537248