Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh — PROVIDE  

Vaccine Virus Shedding Clinical Trial

Official title: Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh

Status Completed

Clinical Trial Summary

Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.

Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.

Secondary Objectives: 1) to determine the impact of an inactivated polio vaccine (IPV) boost on the efficacy of oral polio vaccine and 2) to determine the efficacy of oral rotavirus vaccine to prevent rotavirus diarrhea

The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Diarrhea
• Intestinal Diseases
• Rotavirus Diarrhea
• Tropical Enteropathy
• Vaccine Virus Shedding

• NCT number: NCT01375647
• Study type: Interventional
• Source: University of Vermont
• Status: Completed
• Phase: Phase 3
• Start date: May 2011
• Completion date: November 2014