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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
National Institute of Cholera and Enteric Diseases, India
University of Virginia
University of Vermont
Information provided by (Responsible Party):
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT01571505
First received: March 28, 2012
Last updated: June 16, 2014
Last verified: June 2014
  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 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.


Condition Intervention Phase
Poliomyelitis
Tropical Enteropathy
Biological: IPV vaccination
Phase 1

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

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 372
Study Start Date: March 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Rotavirus vaccination to children at 10 and 17 weeks of age.

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.

  Eligibility

Ages Eligible for Study:   42 Days to 49 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01571505

Locations
India
National Institute of Cholera and Enteric Diseases
Kolkata, India
Sponsors and Collaborators
International Vaccine Institute
Bill and Melinda Gates Foundation
National Institute of Cholera and Enteric Diseases, India
University of Virginia
University of Vermont
Investigators
Principal Investigator: Thomas F. Wierzba, MPH, Ph. D. International Vaccine Institute
Principal Investigator: William Petri, M.D University of Virginia
Principal Investigator: Beth Kirkpatrick, M.D. University of Vermont
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
  More Information

No publications provided

Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT01571505     History of Changes
Other Study ID Numbers: POLIO ROTA-02
Study First Received: March 28, 2012
Last Updated: June 16, 2014
Health Authority: India: Indian Council of Medical Research

Keywords provided by International Vaccine Institute:
Oral vaccines
Vaccine Responsiveness
Tropical Enteropathy

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

ClinicalTrials.gov processed this record on November 25, 2014