Key result
The PROVIDE study successfully established a rigorous clinical trial infrastructure and enrolled a 700-child birth cohort in Bangladesh to evaluate oral rotavirus and polio vaccine efficacy, with efficacy results forthcoming.
Why the study?
Does delayed-dose oral rotavirus vaccine and injectable polio vaccine improve efficacy and immunogenicity in children in developing countries?
RCT (n=700)
Open-label (laboratory personnel and non-clinic site investigators masked)
Permuted blocks with random block size (4 or 8)
No
Does delayed-dose oral rotavirus vaccine and injectable polio vaccine improve efficacy and immunogenicity in children in developing countries?
Describes the methodology of the PROVIDE study, a randomized clinical trial evaluating rotavirus and polio vaccine efficacy in a developing world setting.
Answers are grounded in this paper and cite their sources.
Demonstrates feasibility of birth-cohort vaccine trials in low-resource settings; leaves open delayed-dose rotavirus and polio vaccine efficacy.
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.
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Kirkpatrick et al. (2015) conducted an RCT in Rotavirus diarrhea and poliomyelitis (n=700). Delayed-dosing oral rotavirus vaccine (Rotarix) and inactivated polio vaccine (IPV) vs. No Rotarix; standard 4-dose tOPV series was evaluated on Occurrence of ≥1 episodes of rotavirus diarrhea by 1 year of age (rotavirus arm); presence of fecal shedding of any OPV vaccine virus strains following final OPV dose (polio arm). The PROVIDE study successfully established a rigorous clinical trial infrastructure and enrolled a 700-child birth cohort in Bangladesh to evaluate oral rotavirus and polio vaccine efficacy, with efficacy results forthcoming.
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