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Polio End-game Strategies - Poliovirus Type 2 Challenge Study

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ClinicalTrials.gov Identifier: NCT02189811
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : May 3, 2016
Sponsor:
Collaborators:
World Health Organization
Centers for Disease Control and Prevention
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ali Faisal Saleem, Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: IPV Biological: bOPV Biological: bOPV and IPV Biological: bOPV and IPV and IPV2 Biological: tOPV Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Polio End-game Strategies - Poliovirus Type 2 Challenge Study
Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IPV
IPV at birth, 6 weeks, 10 weeks, 14 weeks, followed by tOPV at 18 and 22 weeks
Biological: IPV
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
Biological: bOPV
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
Biological: bOPV and IPV
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
Biological: bOPV and IPV and IPV2
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
Biological: tOPV
tOPV till 22 weeks of age




Primary Outcome Measures :
  1. Difference in seroprevalence of neutralizing antibodies for type 2 in 19 weeks of age between arms [ Time Frame: 19 weeks of age ]

Secondary Outcome Measures :
  1. Seroprevalence of neutralizing antibodies at 18 weeks of age [ Time Frame: 18 weeks of age ]

Other Outcome Measures:
  1. Difference in shedding of poliovirus type 2 in stool in 19 weeks of age between arms [ Time Frame: 19 weeks of age ]
  2. Difference in seroprevalence of neutralizing antibodies at 22 weeks of age between arms [ Time Frame: 22 weeks of age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189811


Locations
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Pakistan
Rehri goth, Ibrahim Hyderi, Ali Akbar Shah, and Bhens Colony
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
World Health Organization
Centers for Disease Control and Prevention
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Ali F Saleem, MBBS,FCPS,MSc Aga Khan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ali Faisal Saleem, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT02189811    
Other Study ID Numbers: PEGS
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016
Keywords provided by Ali Faisal Saleem, Aga Khan University:
IPV
OPV
tOPV
bOPV
Polio
Endgame
Pakistan
Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases