Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)
1 other identifier
interventional
372
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 28, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedAugust 31, 2017
August 1, 2017
4.8 years
March 28, 2012
August 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.
Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.
Birth to one year
Secondary Outcomes (2)
Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).
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).
Birth to one year
Study Arms (2)
IPV vaccination
EXPERIMENTALRandomized IPV vaccination to children at the age of 39 weeks.
OPV vaccination
PLACEBO COMPARATORRandomized OPV vaccination to children at the age of 39 weeks.
Interventions
Randomized IPV or OPV to children aged at 39weeks.
Eligibility Criteria
You may qualify if:
- Mother willing to sign informed consent form.
- Infant aged 0 to 49 days old.
- No obvious congenital abnormalities or birth defects.
You may not qualify if:
- Parents are not willing to have child's blood drawn.
- Parents are planning to enroll child into another clinical study during the time period of this trial.
- Mother not willing to have blood drawn and breast milk extracted.
- Parents not willing to have field research assistant in home.
- History of seizures or other apparent neurologic disorders.
- Infant does not have proof of BCG and OPV since birth by immunization card.
- History of acute illness and/or immunocompromised state of the child.
- Immunocompromised or chronically ill mother
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International Vaccine Institutelead
- Bill and Melinda Gates Foundationcollaborator
- National Institute of Cholera and Enteric Diseases, Indiacollaborator
- University of Virginiacollaborator
- University of Vermontcollaborator
Study Sites (1)
National Institute of Cholera and Enteric Diseases
Kolkata, India
Related Publications (1)
Kanungo S, Kim DR, Haldar B, Snider C, Nalavade U, Kim SA, Park JY, Sinha A, Mallick AH, Manna B, Sur D, Nandy RK, Deshpande JM, Czerkinsky C, Wierzba TF, Petri WA Jr, Ali M, Dey A. Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial. Heliyon. 2017 Jan 9;3(1):e00223. doi: 10.1016/j.heliyon.2016.e00223. eCollection 2017 Jan.
PMID: 28194449RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2012
First Posted
April 5, 2012
Study Start
March 1, 2012
Primary Completion
November 30, 2016
Study Completion
November 30, 2016
Last Updated
August 31, 2017
Record last verified: 2017-08