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Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh

NCT ID: NCT02477046

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Vaccine Virus Shedding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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tOPV + IPV

tOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive tOPV plus IPV boost

Group Type EXPERIMENTAL

tOPV

Intervention Type BIOLOGICAL

administered per protocol

IPV

Intervention Type BIOLOGICAL

administered per protocol

bOPV + IPV

bOPV (6, 10, and 14 weeks) + IPV (14 weeks) Randomized to receive bOPV plus 1 IPV boost

Group Type EXPERIMENTAL

bOPV

Intervention Type BIOLOGICAL

administered per protocol

IPV

Intervention Type BIOLOGICAL

administered per protocol

bOPV + 2 IPV

bOPV (6, 10, and 14 weeks) + IPV (14 and 18 weeks) Randomized to receive bOPV plus 2 IPV boost

Group Type EXPERIMENTAL

bOPV

Intervention Type BIOLOGICAL

administered per protocol

IPV

Intervention Type BIOLOGICAL

administered per protocol

Interventions

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tOPV

administered per protocol

Intervention Type BIOLOGICAL

bOPV

administered per protocol

Intervention Type BIOLOGICAL

IPV

administered per protocol

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

42 Days

Maximum Eligible Age

48 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Mami Taniuchi, PhD

Assistant Professor of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William A Petri, Jr., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Mami Taniuchi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

K Zaman, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

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International Centre for Diarrhoeal Disease Research, Bangladesh

Matlab, , Bangladesh

Site Status

Countries

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Bangladesh

References

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Taniuchi M, Begum S, Uddin MJ, Platts-Mills JA, Liu J, Kirkpatrick BD, Chowdhury AH, Jamil KM, Haque R, Petri WA Jr, Houpt ER. Kinetics of poliovirus shedding following oral vaccination as measured by quantitative reverse transcription-PCR versus culture. J Clin Microbiol. 2015 Jan;53(1):206-11. doi: 10.1128/JCM.02406-14. Epub 2014 Nov 5.

Reference Type BACKGROUND
PMID: 25378579 (View on PubMed)

Famulare M, Wong W, Haque R, Platts-Mills JA, Saha P, Aziz AB, Ahmed T, Islam MO, Uddin MJ, Bandyopadhyay AS, Yunus M, Zaman K, Taniuchi M. Multiscale model for forecasting Sabin 2 vaccine virus household and community transmission. PLoS Comput Biol. 2021 Dec 21;17(12):e1009690. doi: 10.1371/journal.pcbi.1009690. eCollection 2021 Dec.

Reference Type DERIVED
PMID: 34932560 (View on PubMed)

Taniuchi M, Famulare M, Zaman K, Uddin MJ, Upfill-Brown AM, Ahmed T, Saha P, Haque R, Bandyopadhyay AS, Modlin JF, Platts-Mills JA, Houpt ER, Yunus M, Petri WA Jr. Community transmission of type 2 poliovirus after cessation of trivalent oral polio vaccine in Bangladesh: an open-label cluster-randomised trial and modelling study. Lancet Infect Dis. 2017 Oct;17(10):1069-1079. doi: 10.1016/S1473-3099(17)30358-4. Epub 2017 Jul 7.

Reference Type DERIVED
PMID: 28693854 (View on PubMed)

Study Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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PR-15004

Identifier Type: OTHER

Identifier Source: secondary_id

00000447

Identifier Type: -

Identifier Source: org_study_id