Evaluation of Mucosal Immunity to Polioviruses Following Administration of Polio Vaccines in Pakistan

Assessment of Mucosal Immunity to Polioviruses after Supplemental Poliovirus Vaccines in Different Groups of Healthy Children in Pakistan: A Randomized Controlled Trial; Aga Khan University, Karachi

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000264886

Enrollment

1485

Registered

2012-03-06

Start date

2012-03-15

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This trial will provide the first data on mucosal immunity in children living in a community setting of Pakistan and will 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 polio campaigns (children aged <5 years) should be re-evaluated. Additionally, the trial will compare different markers of mucosal immunity such as measurement of secretory immunoglobulin A (sIgA) levels in gingival fluid or stools and ELISPOT test, with the gold standard test, which is the measurement of vaccine virus shedding after a challenge with a known dose of OPV. Identifying new surrogate markers of mucosal immunity is important because the challenge test requires high workload and resources, and its use in the post-eradication era may not be possible.

Interventions

Four intervention arms: 1) day 0: bOPV; day 28 bOPV 2) day 0: IPV; day 28 bOPV 3) day 0: bOPV + Vitamin A ; day 28 bOPV 4) day 0: bOPV+IPV; day 28 bOPV bOPV: bivalent polio vaccine against types 1 and 3 (dose: two drops administered orally); IPV: inactivated polio vaccine (injectable 0.5 ml)Vitamin A: for children<12 mo 100,000 IU, for children>12 mo 200,000 IU administered orally

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

6 Months to 11 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy children aged 6-11 months, 5-6 years or 10-11-years, that reside within a relatively short and easily accessible distance (<30 km) to the study sites, and do not plan to travel away during entire the study period

Exclusion criteria

Children with known thrombocytopenia or bleeding disorders; children acutely ill or with signs of acute infection (e.g. fever > 101 F) at the time of enrolment; residence >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.

Outcome results