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

Phase 1

Completed

• Conditions: Poliomyelitis; Tropical Enteropathy
• Interventions: Biological: IPV vaccination

• Registration Number: NCT01571505
• Lead Sponsor: International Vaccine Institute

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.

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 Timeline

• Study Start: 2012-03-01
• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-05
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPV vaccination	IPV vaccination	Randomized OPV vaccination to children at the age of 39 weeks.
IPV vaccination	IPV vaccination	Randomized IPV vaccination to children at the age of 39 weeks.

Primary Outcome Measures

Name	Time	Method
Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.	Birth to one year	Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

National Institute of Cholera and Enteric Diseases; 🇮🇳 Kolkata, India