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

April 13, 2015 updated by: Beth Kirkpatrick, University of Vermont

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Mother willing to sign informed consent form.
  2. Healthy infant aged 0 to 7 days old.
  3. No obvious congenital abnormalities or birth defects.
  4. No abnormal (frequency and consistency) stools since birth.
  5. Stable household with no plans to leave the area for the next one year.

Exclusion Criteria:

  1. Parents are not willing to have child vaccinated at the field clinic.
  2. Parents are not willing to have child's blood drawn.
  3. Parents are planning to enroll child into another clinical study during the time period of this trial.
  4. Mother not willing to have blood drawn and breast milk extracted.
  5. Parents not willing to have field research assistant in home two times per week.
  6. History of seizures or other apparent neurologic disorders.
  7. Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG).
  8. Infant has any sibling currently or previously enrolled in this study, including a twin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rotarix + No IPV
Randomized to receive rotarix vaccine but no IPV boost
Biological: Rotarix
Administered per protocol
Experimental: Rotarix + with IPV boost
Randomized to receive both rotarix vaccine and IPV boost
Biological: Rotarix
Administered per protocol
Biological: IPV
Administered per protocol
No Intervention: No Rotarix + No IPV
Randomized to receive neither rotarix vaccine nor IPV boost
Experimental: No Rotarix + with IPV boost
Randomized to receive no rotarix vaccine but to receive IPV boost
Biological: IPV
Administered per protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of fecal shedding of polio vaccine virus determined by culture (polio trial)
Time Frame: 25 days following week 52 visit
25 days following week 52 visit
One or more episodes of rotavirus-associated diarrhea (rotavirus trial)
Time Frame: Birth to one year
Birth to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of fecal shedding of polio vaccine virus (polio trial)
Time Frame: 25 days following week 52 visit
25 days following week 52 visit
Community fecal shedding of polio vaccine virus just prior to one year OPV dose (polio trial)
Time Frame: 52 weeks
52 weeks
Presence and duration of fecal polio virus shedding within the three individual virus strains (polio trial)
Time Frame: 25 days following week 52 visit
25 days following week 52 visit
Serum neutralizing antibody response (polio trial)
Time Frame: 40 weeks and 53 weeks
40 weeks and 53 weeks
Total number of diarrheal episodes (rotavirus trial)
Time Frame: Birth to one year
Birth to one year
Total duration of rotavirus-associated diarrheal episodes (rotavirus trial)
Time Frame: Birth to one year
Birth to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

Washington University School of Medicine
Bill and Melinda Gates Foundation
Stanford University
Centers for Disease Control and Prevention
University of Virginia
International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

  • Principal Investigator: William Petri, M.D., Ph.D., University of Virginia School of Medicine
  • Principal Investigator: Rashidul Haque, M.D., Ph.D., International Center for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 3, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROVIDE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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