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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01571505

Enrollment

372

Registered

2012-04-05

Start date

2012-03-01

Completion date

2016-11-30

Last updated

2017-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poliomyelitis, Tropical Enteropathy

Keywords

Oral vaccines, Vaccine Responsiveness, Tropical Enteropathy

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.

Interventions

BIOLOGICALIPV vaccination

Randomized IPV or OPV to children aged at 39weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

42 Days to 49 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026