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

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ClinicalTrials.gov Identifier: NCT01571505
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : August 31, 2017
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Poliomyelitis Tropical Enteropathy Biological: IPV vaccination Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
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
Actual Study Start Date : March 1, 2012
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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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
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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
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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
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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
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Publications of Results:

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Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT01571505    
Other Study ID Numbers: POLIO ROTA-02
First Posted: April 5, 2012    Key Record Dates
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:
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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