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

August 30, 2017 updated by: International Vaccine Institute

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

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 breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.

Study Type

Interventional

Enrollment (Actual)

372

Phase

  • Phase 1

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

  • India
      • Kolkata, India
        • National Institute of Cholera and Enteric Diseases

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

1 month to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Mother willing to sign informed consent form.
  2. Infant aged 0 to 49 days old.
  3. No obvious congenital abnormalities or birth defects.

Exclusion Criteria:

  1. Parents are not willing to have child's blood drawn.
  2. Parents are planning to enroll child into another clinical study during the time period of this trial.
  3. Mother not willing to have blood drawn and breast milk extracted.
  4. Parents not willing to have field research assistant in home.
  5. History of seizures or other apparent neurologic disorders.
  6. Infant does not have proof of BCG and OPV since birth by immunization card.
  7. History of acute illness and/or immunocompromised state of the child.
  8. Immunocompromised or chronically ill mother

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPV vaccination
Randomized IPV vaccination to children at the age of 39 weeks.
Biological: IPV vaccination
Randomized IPV or OPV to children aged at 39weeks.
Other Names:
  • Rotavirus vaccination to children at 10 and 17 weeks of age.
Placebo Comparator: OPV vaccination
Randomized OPV vaccination to children at the age of 39 weeks.
Biological: IPV vaccination
Randomized IPV or OPV to children aged at 39weeks.
Other Names:
  • Rotavirus vaccination to children at 10 and 17 weeks of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.
Time Frame: Birth to one year
Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.
Birth to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).
Time Frame: Birth to one year
Birth to one year
Mucosal immune responses (shedding OPV vaccine virus) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).
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

International Vaccine Institute

Collaborators

Bill and Melinda Gates Foundation
University of Vermont
University of Virginia
National Institute of Cholera and Enteric Diseases, India

Investigators

  • Principal Investigator: Ayan Dey, Ph.D, International Vaccine Institute
  • Principal Investigator: William Petri, M.D, University of Virginia
  • Principal Investigator: Suman Kanungo, M.D., National Institute of Cholera and Enteric Diseases, India
  • Principal Investigator: Ranjan K Nandy, M.D., National Institute of Cholera and Enteric Diseases, India

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 (Actual)

March 1, 2012

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POLIO ROTA-02

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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