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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

March 28, 2012
April 5, 2012
March 2012
February 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01571505 on ClinicalTrials.gov Archive Site
  • 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 ]
Systemic (neutralizing antibodies) and 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 ]
Not Provided
Not Provided
 
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)
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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
  • Poliomyelitis
  • Tropical Enteropathy
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)+IPV
    Randomized to receive IPV
    Intervention: Biological: Oral vaccines (OPV and rotavirus vaccine) and IPV
  • Experimental: (OPV+Rotavirus vaccine)+OPV (No IPV)
    Randomized to receive OPV (boost), but no IPV
    Intervention: Biological: Oral vaccines (OPV and rotavirus vaccine) and IPV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
372
May 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
up to 6 Weeks
Yes
Contact: Dipika Sur, M.D. 91-33 2353-7519 dipikasur@hotmail.com
India
 
NCT01571505
POLIO ROTA-02
No
International Vaccine Institute
International Vaccine Institute
  • Bill and Melinda Gates Foundation
  • National Institute of Cholera and Enteric Diseases, India
  • University of Virginia
  • University of Vermont
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
International Vaccine Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP