Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000357156p
Ethics application status
Submitted, not yet approved
Date submitted
1/03/2019
Date registered
6/03/2019
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Survey to assess mucosal and humeral polio-immunity in Gadap, Karachi, Pakistan
Scientific title
Survey to assess mucosal and humoral poio-immunity in 1, 4, 9 and 14 year old children living in one of the last reservoirs of poliovirus endemic areas, in Gadap, Karachi, Pakistan
Secondary ID [1] 297585 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polio 311841 0
immunity to poliovirus 311842 0
Condition category
Condition code
Infection 310441 310441 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children in intervention arm will be 9-10 or 14-15 years old - these children are not included in periodic polio vaccination campaigns which target children under 5 years of age

Children will receive one dose (two drops) of bivalent oral poliovirus vaccine (bOPV, Each dose [two-drops ~0.1 ml] contains not less than 10^6.0 CCID50 of Type 1 and 10^5.8 CCID50 of Type 3) as part of this study
Intervention code [1] 313821 0
Other interventions
Comparator / control treatment
Children in comparator arm will be 1-2 or 4-5 years old - these children are included in periodic polio vaccination campaigns which target children under 5 years of age

Children will receive one dose (two drops) of bivalent oral poliovirus vaccine (bOPV, Each dose [two-drops ~0.1 ml] contains not less than 10^6.0 CCID50 of Type 1 and 10^5.8 CCID50 of Type 3) as part of a regular vaccination campaign
Control group
Active

Outcomes
Primary outcome [1] 319310 0
Excretion of polio vaccine poliovirus (Sabin virus) measured by isolation of type specific poliovirus in stool
Timepoint [1] 319310 0
one week after receipt of bOPV
Secondary outcome [1] 367698 0
Difference in excretion of polio vaccine poliovirus (Sabin virus) measured by isolation of type specific poliovirus in stool (serotype 1) between the intervention and comparator study arms
Timepoint [1] 367698 0
one week after administration of bOPV
Secondary outcome [2] 367836 0
Difference in excretion of polio vaccine poliovirus (Sabin virus) measured by isolation of type specific poliovirus in stool (serotype 3) between the intervention and comparator study arms
Timepoint [2] 367836 0
one week after administration of bOPV

Eligibility
Key inclusion criteria
children living in study catchment area (Gadap Union Council 04, Karachi, Pakistan) aged 1-2 years or 4-5 years or 9-10 years or 14-15 years
Minimum age
1 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Suspected immunodeficiecny

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
15/05/2019
Actual
Date of last data collection
Anticipated
15/06/2019
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment outside Australia
Country [1] 21321 0
Pakistan
State/province [1] 21321 0
Sindh

Funding & Sponsors
Funding source category [1] 302136 0
Other
Name [1] 302136 0
World Health Organization
Country [1] 302136 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
Appia Street 20
1200 Geneva
Switzerland
Country
Switzerland
Secondary sponsor category [1] 301972 0
None
Name [1] 301972 0
Address [1] 301972 0
Country [1] 301972 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302816 0
Ethics Review Committee of WHO
Ethics committee address [1] 302816 0
20 Appia
1200 Geneva
Ethics committee country [1] 302816 0
Switzerland
Date submitted for ethics approval [1] 302816 0
21/11/2018
Approval date [1] 302816 0
Ethics approval number [1] 302816 0

Summary
Brief summary
To better understand why wild poliovirus persists in Gadap, and other such areas in Pakistan, it is important to know the proportion and age of children that lack mucosal immunity despite repeated polio vaccination campaigns. These are the children who do not necessarily become paralyzed when infected with poliovirus (PV) but who harbour the PV and further transmit it to others; resulting in continued low level PV circulation that has been observed in Gadap and other areas.
It is known that mucosal immunity rapidly wanes however it is less well understood to what extend this immunity wanes in populations repeatedly vaccinated with OPV. Currently, IPV is added to the routine immunization program in Pakistan and therefore it is possible that there is a growing cohort of children whose humoral immunity is present but mucosal is absent. We intend to quantify this proportion and determine whether there are possible programmatic strategies to target these children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91490 0
Dr Ali Saleem
Address 91490 0
Aga Khan University
Stadium Road, PO Box 3500, Karachi 74800, Sindh
Country 91490 0
Pakistan
Phone 91490 0
+92 21 34930051
Fax 91490 0
Email 91490 0
[email protected]
Contact person for public queries
Name 91491 0
Dr Ondrej Mach
Address 91491 0
World Health Organization
Appia Street 20
1200 Geneva
Country 91491 0
Switzerland
Phone 91491 0
+4122791863
Fax 91491 0
Email 91491 0
[email protected]
Contact person for scientific queries
Name 91492 0
Dr Ondrej Mach
Address 91492 0
World Health Organization
Appia Street 20
1200 Geneva
Country 91492 0
Switzerland
Phone 91492 0
+4122791863
Fax 91492 0
Email 91492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.