ANZCTR - Registration

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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]

None known

Universal Trial Number (UTN)

U1111-1128-7409

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

poliomyelitis

Condition category

Condition code

Infection

Other infectious diseases

Public Health

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]

Prevention

Comparator / control treatment

day 0: no intervention; day 28 bOPV

Control group

Active

Outcomes

Primary outcome [1]

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]

Day 28 of study

Secondary outcome [1]

Increase of sIgA in gingival fluids and stools 28 days after a dose of bOPV or IPV.

Timepoint [1]

Day 28 of study

Secondary outcome [2]

Increase in poliovirus antibody secreting cells (measured with ELISPOT) 7 days following a dose of bOPV or IPV.

Timepoint [2]

Day 7 of study

Secondary outcome [3]

Seroconversion or antibody titre boosting 28 days following a single dose of bOPV or IPV.

Timepoint [3]

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

Sex

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

15/03/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

1485

Accrual to date

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Funding & Sponsors

Funding source category [1]

Other

Name [1]

World Health Organization

Address [1]

World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WHO ERC

Ethics committee address [1]

World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

Approval date [1]

16/09/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ondrej Mach

Address

World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse

Country

Switzerland

Phone

+41227911863

Fax

[email protected]

Contact person for scientific queries

Name

Ondrej Mach

Address

World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse

Country

Switzerland

Phone

+41227911863

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of booster doses of poliovirus vaccine in previously vaccinated children, Clinical Trial Results 2013.	2016	https://dx.doi.org/10.1016/j.vaccine.2016.05.065

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically