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Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh

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ClinicalTrials.gov Identifier: NCT02477046
Recruitment Status : Unknown
Verified October 2016 by Mami Taniuchi, PhD, University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : June 22, 2015
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Mami Taniuchi, PhD, University of Virginia

Study Description
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Brief Summary:

The Strategic Advisory Group of Experts on Immunization (SAGE) has set a plan to replace trivalent oral polio vaccine (tOPV) with bivalent OPV (bOPV) plus inactivated polio vaccine (IPV) in routine immunization globally, to be instituted in 2015-2016. At the community level, the impact of the change from tOPV + IPV to bOPV + IPV on Sabin virus fecal-oral transmission (duration of circulation, degree of genetic reversion) and the persistence of environmental contamination are unknown. Also unknown is the impact of the change from tOPV to bOPV on community circulation of Sabin 2 after a special immunization (SI) activity with monovalent oral poliovirus type 2 (mOPV2). Finally it is unknown at the level of an individual child if type 2 fecal shedding will be limited by cross-protection from oral vaccination with Sabin type 1 and 3.

The investigators propose to measure at a community level transmission of Sabin 2 virus in Bangladesh, a low income country, where fecal-oral transmission and environmental exposures are high, comparing transmission in the setting of vaccination with tOPV+IPV vs. bOPV+IPV. The study will be conducted in 67 villages in Matlab, Bangladesh, using a cluster-randomized study design. Villages in Matlab will be randomly assigned to receive as part of routine immunization (RI) activities: (1) tOPV (6,10,14 weeks) plus IPV at 14 weeks; (2) bOPV (6,10, 14 weeks) plus IPV at 14 weeks; or (3) bOPV (6,10, 14 weeks) plus IPV at 14 and 18 weeks. Community and environmental surveillance for Sabin 2 virus will be conducted in each village over the 9 month period of these RI activities. In addition, a SI activity with mOPV2 will occur 9 months into the study to model an outbreak response. For the 6 months following the mOPV2 challenge, the impact of the different vaccination regimens on Sabin 2 transmission in the community will be determined, as well as individual level protection (as measured by fecal shedding from days 7-70 after mOPV2 challenge).


Condition or disease Intervention/treatment Phase
Vaccine Virus Shedding Biological: tOPV Biological: bOPV Biological: IPV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh
Study Start Date : April 2015
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : June 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: tOPV + IPV
tOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive tOPV plus IPV boost
 Biological: tOPV
administered per protocol

Biological: IPV
administered per protocol
Experimental: bOPV + IPV
bOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive bOPV plus 1 IPV boost
 Biological: bOPV
administered per protocol

Biological: IPV
administered per protocol
Experimental: bOPV + 2 IPV
bOPV (6, 10, and 14 weeks) + IPV (14 and 18 weeks) Randomized to receive bOPV plus 2 IPV boost
 Biological: bOPV
administered per protocol

Biological: IPV
administered per protocol


Outcome Measures
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Primary Outcome Measures :
  1. fecal shedding of type 2 Sabin virus by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 60% of infants that did not receive the mOPV2 challenge [ Time Frame: 10 weeks following mOPV2 challenge at month 9 of the study ]
    The transmission rate of type 2 Sabin virus in the 60% of the enrolled infants that did not receive the mOPV2 challenge between Arm A vs Arm B, Arm A vs Arm C, and Arm B and Arm C.


Secondary Outcome Measures :
  1. fecal shedding of type 2 Sabin virus by RT-qPCR in 40% of infants that received the mOPV2 challenge [ Time Frame: 10 weeks following mOPV2 challenge at month 9 of the study ]
    Individual protection to type 2 poliovirus from different vaccination schedules


Eligibility Criteria
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Ages Eligible for Study:   42 Days to 48 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female infant at least 6 weeks of age (42-48 days) at the time of enrollment
  • For the Special Immunization Activity (SIA) only, being age 5 years or younger at the time of the SIA
  • An infant whose parent or guardian's primary residence, at the time of first Expanded Program on Immunization (EPI) vaccinations, is a village selected to receive polio vaccine.
  • Written informed consent obtained from the parent or guardian of the participant, prior to the participants's first study vaccination

Exclusion Criteria:

  • History of prior polio vaccination (in the 810 infants enrolled at 6 weeks of age only)
  • Hypersensitivity to the active substance or any component in the vaccine
  • Subjects with uncorrected congenital malformation
  • Infants with known or suspected immunodeficiency
Contacts and Locations
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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): NCT02477046


Locations
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Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
Matlab, Bangladesh
Sponsors and Collaborators
University of Virginia
International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: William A Petri, Jr., MD, PhD University of Virginia
Principal Investigator: Mami Taniuchi, PhD University of Virginia
Principal Investigator: K Zaman, MBBS, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
More Information
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Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mami Taniuchi, PhD, Assistant Professor of Research, University of Virginia
ClinicalTrials.gov Identifier: NCT02477046    
Other Study ID Numbers: 00000447
PR-15004 ( Other Identifier: ICDDRB )
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Virus Diseases