Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh

October 24, 2016 updated by: Mami Taniuchi, PhD, University of Virginia

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

810

Phase

  • Phase 3

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

  • Bangladesh
      • Matlab, Bangladesh
        • International Centre for Diarrhoeal Disease Research, Bangladesh

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

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single

Arms and Interventions

Participant Group / 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: IPV
administered per protocol
Biological: bOPV
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: IPV
administered per protocol
Biological: bOPV
administered per protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks following mOPV2 challenge at month 9 of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 weeks following mOPV2 challenge at month 9 of the study

Collaborators and Investigators

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

Sponsor

University of Virginia

Collaborators

Bill and Melinda Gates Foundation
International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

  • 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

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.

General Publications

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

April 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00000447
  • PR-15004 (Other Identifier: ICDDRB)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Statistical Analysis Plan

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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