To find out biological causes of Oral polio and Rotavirus Vaccine failure in India.

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccine in India - PROVIDE study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002504

Enrollment

372

Registered

2012-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Inactivated polio vaccine (IPV): Half of the children (186) will be randomized to receive an inactivated polio vaccine (IPV) boost at 39 weeks of age, instead of OPV at this time point.

Eligibility

Inclusion criteria

Inclusion criteria: All of the following criteria must be met for a subject to be eligible to participate in the study: 1.Mother willing to sign informed consent form. 2.Infant aged 0 to 49 days old. 3.No obvious congenital abnormalities or birth defects. 4.Stable household with no plans to leave the area for the next one year.

Exclusion criteria

Exclusion criteria: Meeting any of the following criteria at baseline will exclude a subject from study participation: 1.Parents are not willing to have childâ??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 9.Infant has any sibling currently or previously enrolled in this study, including a twin.

Design outcomes

Primary

Measure	Time frame
The proportion of subjects with a positive immune response to OPV versus proportion of subjects with a positive immune response to OPV plus IPVTimepoint: Analysis for plasma neutralizing antibodies to poliovirus will be conducted on plasma samples taken from weeks 6, 18, 40, and once between weeks 53-54.	—

Secondary

Measure	Time frame
1.Determine whether breast milk antibodies interfere with immune responses to polio and rotavirus vaccines. 2.Determine whether maternal plasma antibodies interfere with immune responses to poliovirus vaccines. 3. Determine whether malnutrition is associated with decreased responses to oral vaccination. 4. Determine whether the following additional biomarkers and immune markers correlate with immune response to oral polio or rotavirus vaccination: through ELISPOT, and plasma IgG/IgA. Timepoint: at 6,18, 40 and 54 weeks	—

Measure

Time frame

1.Determine whether breast milk antibodies interfere with immune responses to polio and rotavirus vaccines. 2.Determine whether maternal plasma antibodies interfere with immune responses to poliovirus vaccines. 3. Determine whether malnutrition is associated with decreased responses to oral vaccination. 4. Determine whether the following additional biomarkers and immune markers correlate with immune response to oral polio or rotavirus vaccination: through ELISPOT, and plasma IgG/IgA. Timepoint: at 6,18, 40 and 54 weeks

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Countries

India

Contacts

Public ContactDr Dipika Sur

NATIONAL INSTITUTE OF CHOLERA AND ENTERIC DISEASES

dipikasur@hotmail.com91-33-23505533

Outcome results