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Trial registered on ANZCTR


Registration number
ACTRN12612000264886
Ethics application status
Approved
Date submitted
29/02/2012
Date registered
6/03/2012
Date last updated
18/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Mucosal Immunity to Polioviruses Following Administration of Polio Vaccines in Pakistan
Scientific title
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
Secondary ID [1] 280061 0
None known
Universal Trial Number (UTN)
U1111-1128-7409
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poliomyelitis 285971 0
Condition category
Condition code
Infection 286158 286158 0 0
Other infectious diseases
Public Health 286159 286159 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 284384 0
Prevention
Comparator / control treatment
day 0: no intervention; day 28 bOPV
Control group
Active

Outcomes
Primary outcome [1] 286631 0
Reduction in excretion of a challenge dose of vaccine poliovirus administered 28 days after a single dose of bOPV or IPV following a challenge dose with bOPV, compared to an unvaccinated control arm. This outcome is assessed by comparision of viral shedding in stool of enrolled children.
Timepoint [1] 286631 0
Day 28 of study
Secondary outcome [1] 296328 0
Increase of sIgA in gingival fluids and stools 28 days after a dose of bOPV or IPV.
Timepoint [1] 296328 0
Day 28 of study
Secondary outcome [2] 296329 0
Increase in poliovirus antibody secreting cells (measured with ELISPOT) 7 days following a dose of bOPV or IPV.
Timepoint [2] 296329 0
Day 7 of study
Secondary outcome [3] 296330 0
Seroconversion or antibody titre boosting 28 days following a single dose of bOPV or IPV.
Timepoint [3] 296330 0
Day 28 of study

Eligibility
Key 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
Minimum age
6 Months
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4178 0
Pakistan
State/province [1] 4178 0

Funding & Sponsors
Funding source category [1] 284813 0
Other
Name [1] 284813 0
World Health Organization
Address [1] 284813 0
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Country [1] 284813 0
Switzerland
Primary sponsor type
Other
Name
WHO
Address
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Country
Switzerland
Secondary sponsor category [1] 283694 0
None
Name [1] 283694 0
Address [1] 283694 0
Country [1] 283694 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286803 0
WHO ERC
Ethics committee address [1] 286803 0
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Ethics committee country [1] 286803 0
Switzerland
Date submitted for ethics approval [1] 286803 0
Approval date [1] 286803 0
16/09/2011
Ethics approval number [1] 286803 0
RPC 456

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33849 0
Address 33849 0
Country 33849 0
Phone 33849 0
Fax 33849 0
Email 33849 0
Contact person for public queries
Name 17096 0
Ondrej Mach
Address 17096 0
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Country 17096 0
Switzerland
Phone 17096 0
+41227911863
Fax 17096 0
Email 17096 0
macho@who.int
Contact person for scientific queries
Name 8024 0
Ondrej Mach
Address 8024 0
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Country 8024 0
Switzerland
Phone 8024 0
+41227911863
Fax 8024 0
Email 8024 0
macho@who.int

No information has been provided regarding IPD availability
Summary results
No Results