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

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 IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix 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.

Conditions

• Rotavirus Diarrhea
• Vaccine Virus Shedding
• Tropical Enteropathy

Interventions

BIOLOGICAL

IPV (inactivated polio vaccine)

Administered per protocol

BIOLOGICAL

Rotarix

Administered per protocol

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• University of Vermont

  lead OTHER

Principal Investigators

• Beth Kirkpatrick, M.D. · University of Vermont

• William Petri, M.D., Ph.D. · University of Virginia School of Medicine

• Rashidul Haque, M.D., Ph.D. · International Center for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Max Age

7 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2014-10-31

Completion

2014-11-30

Countries

• Bangladesh

Study Locations