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Delayed Dosing of Oral Rotavirus Vaccine Demonstrates Decreased Risk of Rotavirus Gastroenteritis Associated With Serum Zinc: A Randomized Controlled Trial.
Colgate, E Ross; Haque, Rashidul; Dickson, Dorothy M; Carmolli, Marya P; Mychaleckyj, Josyf C; Nayak, Uma; Qadri, Firdausi; Alam, Masud; Walsh, Mary Claire; Diehl, Sean A; Zaman, K; Petri, William A; Kirkpatrick, Beth D.
Afiliação
  • Colgate ER; Department of Medicine, Vaccine Testing Center and Unit of Infectious Diseases, University of Vermont College of Medicine, Burlington.
  • Haque R; International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.
  • Dickson DM; Department of Medicine, Vaccine Testing Center and Unit of Infectious Diseases, University of Vermont College of Medicine, Burlington.
  • Carmolli MP; Department of Medicine, Vaccine Testing Center and Unit of Infectious Diseases, University of Vermont College of Medicine, Burlington.
  • Mychaleckyj JC; Department of Public Health Sciences Center for Public Health Genomics, University of Virginia.
  • Nayak U; Center for Public Health Genomics, University of Virginia.
  • Qadri F; International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.
  • Alam M; International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.
  • Walsh MC; Department of Medicine, Vaccine Testing Center and Unit of Infectious Diseases, University of Vermont College of Medicine, Burlington.
  • Diehl SA; Department of Medicine, Vaccine Testing Center and Unit of Infectious Diseases, University of Vermont College of Medicine, Burlington.
  • Zaman K; International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.
  • Petri WA; Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville.
  • Kirkpatrick BD; Department of Medicine, Vaccine Testing Center and Unit of Infectious Diseases, University of Vermont College of Medicine, Burlington.
Clin Infect Dis ; 63(5): 634-41, 2016 Sep 01.
Article em En | MEDLINE | ID: mdl-27217217
BACKGROUND: Rotavirus is the world's leading cause of childhood diarrheal death. Despite successes, oral rotavirus vaccines are less effective in developing countries. In an urban slum of Dhaka, we performed active diarrhea surveillance to evaluate monovalent G1P[8] rotavirus vaccine (RV1) efficacy and understand variables contributing to risk of rotavirus diarrhea (RVD). METHODS: We performed a randomized controlled trial of monovalent oral rotavirus vaccine (RV1). Seven hundred healthy infants received RV1 or no RV1 (1:1) using delayed dosing (10 and 17 weeks) and were followed for 1 year. Intensive diarrhea surveillance was performed. The primary outcome was ≥1 episode of RVD. Nutritional, socioeconomic, and immunologic factors were assessed by logistic regression best-subsets analysis for association with risk of RVD and interactions with vaccine arm. RESULTS: Incidence of all RVD was 38.3 cases per 100 person-years. Per-protocol RV1 efficacy was 73.5% (95% confidence interval [CI], 45.8%-87.0%) against severe RVD and 51% (95% CI, 33.8%-63.7%) against all RVD. Serum zinc level (odds ratio [OR], 0.77; P = .002) and lack of rotavirus immunoglobulin A (IgA) seroconversion (OR, 1.95; P = .018) were associated with risk of RVD, independent of vaccination status. Water treatment and exclusive breastfeeding were of borderline significance. Factors not associated with RVD included height for age at 10 weeks, vitamin D, retinol binding protein, maternal education, household income, and sex. CONCLUSIONS: In an urban slum with high incidence of RVD, the efficacy of RV1 against severe RVD was higher than anticipated in the setting of delayed dosing. Lower serum zinc level and lack of IgA seroconversion were associated with increased risk of RVD independent of vaccination. CLINICAL TRIALS REGISTRATION: NCT01375647.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções por Rotavirus / Zinco / Vacinas contra Rotavirus / Gastroenterite Tipo de estudo: Clinical_trials / Etiology_studies / Guideline / Incidence_studies / Prognostic_studies / Risk_factors_studies Limite: Female / Humans / Male / Newborn País/Região como assunto: Asia Idioma: En Ano de publicação: 2016 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções por Rotavirus / Zinco / Vacinas contra Rotavirus / Gastroenterite Tipo de estudo: Clinical_trials / Etiology_studies / Guideline / Incidence_studies / Prognostic_studies / Risk_factors_studies Limite: Female / Humans / Male / Newborn País/Região como assunto: Asia Idioma: En Ano de publicação: 2016 Tipo de documento: Article