assesment of Immunity to polio Virus after dose of BOPV or IPV in Children in Northern India

ASSESSMENT OF MUCOSAL IMMUNITY TO POLIOVIRUSES AFTER A SUPPLEMENTAL DOSE OF BIVALENT ORAL POLIOVIRUS VACCINE OR INACTIVATED POLIOVIRUS VACCINE IN CHILDREN IN NORTHERN INDIA: A RANDOMIZED TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/09/002018

Enrollment

990

Registered

2011-09-26

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: IPV,: 0.5 ml of ipv by intramuscular route at first visit.At second visit or last visit only 2 drops of bOPV will be given orally to all subjects. The total duration of treatment is 28

Eligibility

Inclusion criteria

Inclusion criteria: Healthy children aged 6 to 11 months 5 to 6 years or 10 to 11years who reside within a relatively short and easily accessible distance within 30 km to the study sites and do not plan to travel away during entire study period of next 2 months

Exclusion criteria

Exclusion criteria: Children with known thrombocytopenia or bleeding disorders children acutely ill or with signs of acute infection like fever of more than 101 F at the time of enrolment residence of more than 30 km from study site or families expecting to be absent during the 60 day study period A diagnosis or suspicion of immunodeficiency disorder either in the participant or in a member of the immediate family will also render the child ineligible for the study

Design outcomes

Primary

Measure	Time frame
The proposed trial will evaluate mucosal immunity before and after receipt of two different poliovirus vaccine types, in children living in areas at high risk for poliovirus infectionTimepoint: At baseline -blood sample , oral fluid, and stool samples. children 10-11 years of age a second blood sample will be collected at 7 days. All children, at 28 days, blood sample , oral fluid sample and a stool sample will be collected . At days 3, 7 and 14 stool samples will be collected. At day 56, serum sample and oral fluid sample will be collected.	—

Measure

Time frame

The proposed trial will evaluate mucosal immunity before and after receipt of two different poliovirus vaccine types, in children living in areas at high risk for poliovirus infectionTimepoint: At baseline -blood sample , oral fluid, and stool samples. children 10-11 years of age a second blood sample will be collected at 7 days. All children, at 28 days, blood sample , oral fluid sample and a stool sample will be collected . At days 3, 7 and 14 stool samples will be collected. At day 56, serum sample and oral fluid sample will be collected.

—

Secondary

Measure	Time frame
This trial will also assess which polio vaccines are more efficient in boosting mucosal immunity, which would provide an effective barrier to subsequent excretion and community spread of poliovirus. The data from this trial will likely have programmatic implications, especially in determining whether the current age range for SIAs (children aged 5 years) should be re-evaluated.Timepoint: Assessment of Safety Specification of the safety parameters: All participants will be informed to contact the study personnel if the child requires medical care. The timepoints would be: ? Increase of sIgA in gingival fluids and stools 28 days after a dose of bOPV or IPV. ? Increase in poliovirus antibody secreting cells (measured with ELISPOT) 7 days following a dose of bOPV or IPV. ? Seroconversion or antibody titer boosting 28 days following a single dose of bOPV or IPV.	—

Measure

Time frame

This trial will also assess which polio vaccines are more efficient in boosting mucosal immunity, which would provide an effective barrier to subsequent excretion and community spread of poliovirus. The data from this trial will likely have programmatic implications, especially in determining whether the current age range for SIAs (children aged 5 years) should be re-evaluated.Timepoint: Assessment of Safety Specification of the safety parameters: All participants will be informed to contact the study personnel if the child requires medical care. The timepoints would be: ? Increase of sIgA in gingival fluids and stools 28 days after a dose of bOPV or IPV. ? Increase in poliovirus antibody secreting cells (measured with ELISPOT) 7 days following a dose of bOPV or IPV. ? Seroconversion or antibody titer boosting 28 days following a single dose of bOPV or IPV.

—

Countries

India

Contacts

Public ContactDr Arani Chatterjee

Panacea Biotec Ltd

aranichatterjee@PANACEABIOTEC.COM919871371499

Outcome results