Polio End-game Strategies - Poliovirus Type 2 Challenge Study
1 other identifier
interventional
900
1 country
1
Brief Summary
Poliomyelitis eradication has entered its last phase with only three remaining endemic countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2 since 1999, and no case of wild type poliovirus 3 since November 2012. However, paralytic polio resulting from circulating strains of Sabin poliovirus type 2 have become a challenge, and reported from several areas with low population immunity to polio, including in Pakistan. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 3, 2016
May 1, 2016
1.6 years
July 9, 2014
May 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in seroprevalence of neutralizing antibodies for type 2 in 19 weeks of age between arms
19 weeks of age
Secondary Outcomes (1)
Seroprevalence of neutralizing antibodies at 18 weeks of age
18 weeks of age
Other Outcomes (2)
Difference in shedding of poliovirus type 2 in stool in 19 weeks of age between arms
19 weeks of age
Difference in seroprevalence of neutralizing antibodies at 22 weeks of age between arms
22 weeks of age
Study Arms (5)
IPV
EXPERIMENTALIPV at birth, 6 weeks, 10 weeks, 14 weeks, followed by tOPV at 18 and 22 weeks
bOPV
EXPERIMENTALbOPV at birth, 6, 10, and 14 weeks. followed by tOPV at 18 and 22 weeks of age
bOPV and IPV
EXPERIMENTALbOPV at birth, 6, 10 weeks, and IPV+bOPV at 14 weeks, and tOPV at 18 and 22 weeks of age
bOPV and IPV and IPV2
EXPERIMENTALbOPV at birth, 6, 10 weeks and bOPV+IPV at 14 weeks and tOPV+IPV2 at 18 weeks and tOPV alone at 22 weeks of age
tOPV
ACTIVE COMPARATORtOPV at birth, 6, 10, 14, 18 and 22 weeks of age
Interventions
bOPV till week 10, bOPV+IPV at 14 and tOPV at 18 and 22 weeks of age
bOPV till week 10, bOPV+IPV at 14, tOPV+IPV2 at 18 and tOPV at 22 weeks of age
Eligibility Criteria
You may qualify if:
- Newborn of either gender born healthy with birth weight 2.0 kg or more, with immediate cry, at the study sites (home or health facility births)
- Not planning to travel away during entire the study period (birth-154 days; birth 22 weeks).
- Parents resident of the study area for last 3 month at the time of enrolment
- Parent/guardian provides informed consent
You may not qualify if:
- Newborns found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization, birth weight below 2.0 kg, cry \>2 minutes after birth, or family is planning to be absent during the birth - 154 days study period
- Refusal of blood testing and cord blood testing
- Receipt of OPV after birth before eligibility screen
- Newborns with certain medical conditions i.e., syndromic infants, neonate with petechial or purpura (contraindication of intramuscular injections)
- A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family - e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aga Khan Universitylead
- World Health Organizationcollaborator
- Centers for Disease Control and Preventioncollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Rehri goth, Ibrahim Hyderi, Ali Akbar Shah, and Bhens Colony
Karachi, Sindh, Pakistan
Related Publications (1)
Saleem AF, Yousafzai MT, Mach O, Khan A, Quadri F, Weldon WC, Oberste MS, Zaidi SS, Alam MM, Sutter RW, Zaidi AKM. Evaluation of vaccine derived poliovirus type 2 outbreak response options: A randomized controlled trial, Karachi, Pakistan. Vaccine. 2018 Mar 20;36(13):1766-1771. doi: 10.1016/j.vaccine.2018.02.051. Epub 2018 Feb 21.
PMID: 29477307DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali F Saleem, MBBS,FCPS,MSc
Aga Khan University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 9, 2014
First Posted
July 15, 2014
Study Start
September 1, 2014
Primary Completion
April 1, 2016
Study Completion
May 1, 2016
Last Updated
May 3, 2016
Record last verified: 2016-05