Overview

This trial is active, not recruiting.

Conditions poliomyelitis, tropical enteropathy
Treatment ipv vaccination
Phase phase 1
Sponsor International Vaccine Institute
Collaborator Bill and Melinda Gates Foundation
Start date March 2012
End date July 2015
Trial size 372 participants
Trial identifier NCT01571505, POLIO ROTA-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose basic science
Arm
(Experimental)
Randomized IPV vaccination to children at the age of 39 weeks.
ipv vaccination Rotavirus vaccination to children at 10 and 17 weeks of age.
Randomized IPV or OPV to children aged at 39weeks.
(Placebo Comparator)
Randomized OPV vaccination to children at the age of 39 weeks.
ipv vaccination Rotavirus vaccination to children at 10 and 17 weeks of age.
Randomized IPV or OPV to children aged at 39weeks.

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 42 days up to 49 days old.

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

Additional Information

Official title Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA
Principal investigator Thomas F. Wierzba, MPH, Ph. D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by International Vaccine Institute.