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The "Performance of Rotavirus and Oral Polio Vaccines in Developing Countries" (PROVIDE) study: description of methods of an interventional study designed to explore complex biologic problems.

Abstract
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.
AuthorsBeth D Kirkpatrick, E Ross Colgate, Josyf C Mychaleckyj, Rashidul Haque, Dorothy M Dickson, Marya P Carmolli, Uma Nayak, Mami Taniuchi, Caitlin Naylor, Firdausi Qadri, Jennie Z Ma, Masud Alam, Mary Claire Walsh, Sean A Diehl, PROVIDE Study Teams, William A Petri Jr
JournalThe American journal of tropical medicine and hygiene (Am J Trop Med Hyg) Vol. 92 Issue 4 Pg. 744-51 (Apr 2015) ISSN: 1476-1645 [Electronic] United States
PMID25711607 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright© The American Society of Tropical Medicine and Hygiene.
Chemical References
  • Antibodies, Viral
  • Poliovirus Vaccine, Oral
  • Poliovirus Vaccines
  • Rotavirus Vaccines
  • Vaccines, Attenuated
Topics
  • Administration, Oral
  • Antibodies, Viral (blood)
  • Bangladesh
  • Child
  • Child, Preschool
  • Cohort Studies
  • Developing Countries
  • Female
  • Humans
  • Infant
  • Male
  • Poliomyelitis (immunology, prevention & control)
  • Poliovirus (immunology)
  • Poliovirus Vaccine, Oral (administration & dosage, immunology)
  • Poliovirus Vaccines (administration & dosage, immunology)
  • Rotavirus (immunology)
  • Rotavirus Infections (immunology, prevention & control)
  • Rotavirus Vaccines (administration & dosage, immunology)
  • Vaccines, Attenuated (administration & dosage, immunology)

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