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

International Vaccine Institute (IVI)

Status and phase: Completed; Phase 1

Conditions: Poliomyelitis; Tropical Enteropathy

Treatments: Biological: IPV vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT01571505

POLIO ROTA-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 patients

Sex: All

Ages: 42 to 49 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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372 participants in 2 patient groups, including a placebo group

IPV vaccination

Experimental group

Description:

Randomized IPV vaccination to children at the age of 39 weeks.

Treatment:

Biological: IPV vaccination

OPV vaccination

Placebo Comparator group

Description:

Randomized OPV vaccination to children at the age of 39 weeks.

Treatment:

Biological: IPV vaccination