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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571505
First Posted: April 5, 2012
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    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 ]
  • 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 ]

Enrollment: 372
Actual Study Start Date: March 1, 2012
Study Completion Date: November 30, 2016
Primary Completion Date: November 30, 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Days to 49 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Ayan Dey, 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

Publications:
Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT01571505     History of Changes
Other Study ID Numbers: POLIO ROTA-02
First Submitted: March 28, 2012
First Posted: April 5, 2012
Last Update Posted: August 31, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Poliomyelitis
Intestinal Diseases
Sprue, Tropical
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Metabolic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs