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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
University of Virginia
International Centre for Diarrhoeal Disease Research, Bangladesh
Washington University School of Medicine
Stanford University
Information provided by (Responsible Party):
Beth Kirkpatrick, University of Vermont
ClinicalTrials.gov Identifier:
NCT01375647
First received: June 3, 2011
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Rotavirus Diarrhea
Polio Serum Neutralizing Antibody
Polio Vaccine Virus Shedding
Tropical Enteropathy
Biological: IPV
Biological: Rotarix
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Polio serum neutralizing antibody [ Time Frame: at 18 weeks ] [ Designated as safety issue: No ]
  • One or more episodes of Rotavirus-associated diarrhea [ Time Frame: Birth to one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of fecal shedding of polio vaccine virus in IPV vaccinees and non IPV vaccinees [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
  • One or more episodes of Rotavirus-associated diarrhea in Rotarix vaccinees and non Rotarix vaccinees [ Time Frame: Birth to one year ] [ Designated as safety issue: No ]

Enrollment: 700
Study Start Date: May 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: IPV
Administered per protocol
Biological: Rotarix
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

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375647

Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
Sponsors and Collaborators
University of Vermont
Bill and Melinda Gates Foundation
University of Virginia
International Centre for Diarrhoeal Disease Research, Bangladesh
Washington University School of Medicine
Stanford University
Investigators
Principal Investigator: Beth Kirkpatrick, M.D. University of Vermont
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
  More Information

No publications provided

Responsible Party: Beth Kirkpatrick, M.D., University of Vermont
ClinicalTrials.gov Identifier: NCT01375647     History of Changes
Other Study ID Numbers: PROVIDE
Study First Received: June 3, 2011
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board
Bangladesh: International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) Research Review Committee
Bangladesh: ICDDR, B Ethics REview Committee

Keywords provided by University of Vermont:
Oral Vaccines
Vaccine Responsiveness
Tropical Enteropathy

Additional relevant MeSH terms:
Poliomyelitis
Diarrhea
Intestinal Diseases
Sprue, Tropical
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on August 01, 2014