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

This study is currently recruiting participants.
Verified April 2012 by International Vaccine Institute
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: April 5, 2012
Last verified: April 2012
History of Changes
  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: Oral vaccines (OPV and rotavirus vaccine) and IPV
 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:

Drug Information available for: Rotarix
U.S. FDA Resources

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 lactouse/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: (OPV+Rotavirus vaccine)+IPV
Randomized to receive IPV
 Biological: Oral vaccines (OPV and rotavirus vaccine) and IPV
Randomized to receive IPV or no IPV (OPV boost)
Other Name: Oral rotavirus give to child at 10 weeks of age and 17 weeks of age.
Experimental: (OPV+Rotavirus vaccine)+OPV (No IPV)
Randomized to receive OPV (boost), but no IPV
 Biological: Oral vaccines (OPV and rotavirus vaccine) and IPV
Randomized to receive IPV or no IPV (OPV boost)
Other Name: Oral rotavirus give to child at 10 weeks of age 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:   up to 6 Weeks
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.
  4. Stable household with no plans to leave the area for the next one year.

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
  9. Infant has any sibling currently or previously enrolled in this study, including a twin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571505

Contacts
Contact: Dipika Sur, M.D. 91-33 2353-7519 dipikasur@hotmail.com

Locations
India
National Institute of Cholera and Enteric Diseases Recruiting
Kolkata, India
Contact: Dipika Sur, M.D.     (91-33) 2353-7519     dipikasur@hotmail.com    
Principal Investigator: Dipika Sur, M.D.            
Sub-Investigator: Mrinal Kanti Chatterjee, M.D.            
Sub-Investigator: Byomkesh Manna, Ph D.            
Sub-Investigator: Malay Saha, Ph. D.            
Sub-Investigator: Ranjan Kumar Nandy, Ph.D.            
Sub-Investigator: Suman Kanungo, M.D.            
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: Dipika Sur, M.D. National Institute of Cholera and Enteric Diseases, India
Principal Investigator: Cecil Czerkinsky, DVM, Ph. D. International Vaccine Institute
Principal Investigator: William Petri, M.D University of Virginia
Principal Investigator: Beth Kirkpatrick, M.D. University of Vermont
  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: April 5, 2012
Health Authority: India: Indian Council of Medical Research

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

Additional relevant MeSH terms:
Poliomyelitis
Intestinal Diseases
Sprue, Tropical
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 May 16, 2013