Polio End-game Strategies - Poliovirus Type 2 Challenge Study

May 2, 2016 updated by: Ali Faisal Saleem, Aga Khan University
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.

Study Overview

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

Interventional

Enrollment (Actual)

900

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sindh
      • Karachi, Sindh, Pakistan
        • Rehri goth, Ibrahim Hyderi, Ali Akbar Shah, and Bhens Colony

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ali F Saleem, MBBS,FCPS,MSc, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

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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