- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02189811
Polio End-game Strategies - Poliovirus Type 2 Challenge Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The "Polio Endgame Strategy" consists of set of tasks and activities that will be implemented in the next five years. It includes gradual withdrawal of the widely used oral poliomyelitis vaccine (OPV) containing live poliovirus, and will eventually lead to complete eradication and containment of all wild, vaccine-related (VDPV) and Sabin polioviruses. The withdrawal of the type 2 components of trivalent OPV (tOPV) is the key component in the elimination of cVDPVs. This entails strengthening of the immunization system by introducing at least one dose of affordable IPV into the routine immunization schedule globally and then replacing the trivalent OPV with bivalent OPV in all OPV-using countries - setting the stage for eventually ending bOPV use in 2019-2020. Most of the developing countries have an OPV schedule however many developed and European countries follow the IPV only schedule. The current recommendations for polio eradication and endgame is IPV vaccine to be administered together with third OPV dose, which in most countries occurs at 14 weeks of age.
This study will assess the protection to type 2 poliovirus achieved after completion of the recommended schedule with bOPV and IPV; it will compare immunogenicity of bOPV + IPV schedule with tOPV only schedule; and will quantify the cross-reactivity of bOPV on inducing type 2 immunological reaction. In addition, it will also provide first data on the proposed outbreak response to type 2 (either with mOPV 2 or with a combination of mOPV 2 and IPV 2).
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Sindh
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Karachi, Sindh, Pakistan
- Rehri goth, Ibrahim Hyderi, Ali Akbar Shah, and Bhens Colony
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IPV
IPV at birth, 6 weeks, 10 weeks, 14 weeks, followed by tOPV at 18 and 22 weeks
|
IPV at birth, 6, 10, 14 weeks of age and tOPV at 18 and 22 weeks of age
|
Experimental: bOPV
bOPV at birth, 6, 10, and 14 weeks.
followed by tOPV at 18 and 22 weeks of age
|
bOPV at birth, 6, 10, 14 weeks and tOPV at 18 and 22 weeks of age
|
Experimental: bOPV and IPV
bOPV at birth, 6, 10 weeks, and IPV+bOPV at 14 weeks, and tOPV at 18 and 22 weeks of age
|
bOPV till week 10, bOPV+IPV at 14 and tOPV at 18 and 22 weeks of age
|
Experimental: bOPV and IPV and IPV2
bOPV 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
|
bOPV till week 10, bOPV+IPV at 14, tOPV+IPV2 at 18 and tOPV at 22 weeks of age
|
Active Comparator: tOPV
tOPV at birth, 6, 10, 14, 18 and 22 weeks of age
|
tOPV till 22 weeks of age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in seroprevalence of neutralizing antibodies for type 2 in 19 weeks of age between arms
Time Frame: 19 weeks of age
|
19 weeks of age
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Seroprevalence of neutralizing antibodies at 18 weeks of age
Time Frame: 18 weeks of age
|
18 weeks of age
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in shedding of poliovirus type 2 in stool in 19 weeks of age between arms
Time Frame: 19 weeks of age
|
19 weeks of age
|
Difference in seroprevalence of neutralizing antibodies at 22 weeks of age between arms
Time Frame: 22 weeks of age
|
22 weeks of age
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ali F Saleem, MBBS,FCPS,MSc, Aga Khan University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEGS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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