{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T13:45:19Z","timestamp":1793886319968,"version":"4.8.0"},"reference-count":22,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2015,4,1]]},"abstract":"<jats:p>Oral vaccines appear less effective in children in the developing world. Proposed biologic reasons include concurrent enteric infections, malnutrition, breast milk interference, and environmental enteropathy (EE). Rigorous study design and careful data management are essential to begin to understand this complex problem while assuring research subject safety. Herein, we describe the methodology and lessons learned in the PROVIDE study (Dhaka, Bangladesh). A randomized clinical trial platform evaluated the efficacy of delayed-dose oral rotavirus vaccine as well as the benefit of an injectable polio vaccine replacing one dose of oral polio vaccine. This rigorous infrastructure supported the additional examination of hypotheses of vaccine underperformance. Primary and secondary efficacy and immunogenicity measures for rotavirus and polio vaccines were measured, as well as the impact of EE and additional exploratory variables. Methods for the enrollment and 2-year follow-up of a 700 child birth cohort are described, including core laboratory, safety, regulatory, and data management practices. Intense efforts to standardize clinical, laboratory, and data management procedures in a developing world setting provide clinical trials rigor to all outcomes. Although this study infrastructure requires extensive time and effort, it allows optimized safety and confidence in the validity of data gathered in complex, developing country settings.<\/jats:p>","DOI":"10.4269\/ajtmh.14-0518","type":"journal-article","created":{"date-parts":[[2015,2,26]],"date-time":"2015-02-26T08:33:01Z","timestamp":1424939581000},"page":"744-751","source":"Crossref","is-referenced-by-count":108,"title":["The \u201cPerformance of Rotavirus and Oral Polio Vaccines in Developing Countries\u201d (PROVIDE) Study: Description of Methods of an Interventional Study Designed to Explore Complex Biologic Problems"],"prefix":"10.4269","volume":"92","author":[{"given":"Beth D.","family":"Kirkpatrick","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E. Ross","family":"Colgate","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josyf C.","family":"Mychaleckyj","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rashidul","family":"Haque","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dorothy M.","family":"Dickson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marya P.","family":"Carmolli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uma","family":"Nayak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mami","family":"Taniuchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caitlin","family":"Naylor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Firdausi","family":"Qadri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennie Z.","family":"Ma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masud","family":"Alam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary Claire","family":"Walsh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean A.","family":"Diehl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"_","family":"_","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William A.","family":"Petri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"R1","series-title":"JAMA","first-page":"2243","article-title":"Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicaragua","volume":"301","author":"Patel","year":"2009"},{"key":"R2","series-title":"Lancet","first-page":"615","article-title":"Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled 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questions","volume":"360","author":"Parashar","year":"2009"},{"issue":"(Suppl 1)","key":"R8","series-title":"J Infect Dis","first-page":"S39","article-title":"Oral rotavirus vaccines: how well will they work where they are needed most?","volume":"200","author":"Patel","year":"2009"},{"key":"R9","series-title":"Clin Infect Dis","first-page":"185","article-title":"Contribution of enteric infection, altered intestinal barrier function, and maternal malnutrition to infant malnutrition in Bangladesh","volume":"42","author":"Mondal","year":"2012"},{"key":"R10","series-title":"J Immunol","first-page":"5011","article-title":"Induction of mucosal immunity by inactivated poliovirus vaccine is dependent on previous mucosal contact with live virus","volume":"162","author":"Herremans","year":"1999"},{"key":"R11","series-title":"J Infect Dis","first-page":"794","article-title":"Mucosal immunity after vaccination with monovalent and trivalent oral poliovirus vaccine in 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Organization","year":"2004"},{"key":"R19","series-title":"Manual for the Virological Investigation of Poliomyelitis","author":"World Health Organization","year":"1997"},{"key":"R20","series-title":"Am J Clin Nutr","first-page":"1040","article-title":"Effect of Lactobacillus GG on intestinal integrity in Malawian children at risk of tropical enteropathy","volume":"82","author":"Galpin","year":"2005"},{"key":"R21","article-title":"Rapid development of research databases with Web access, flexible schemas, and linkage to local data resources","author":"Harrison","year":"2011"},{"key":"R22","article-title":"Development of a dynamic Web interface tool for research databases","author":"Lyman","year":"2010"}],"container-title":["The American Society of Tropical Medicine and 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