Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh

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).

Conditions

• Vaccine Virus Shedding

Interventions

BIOLOGICAL

tOPV

administered per protocol

BIOLOGICAL

bOPV

administered per protocol

BIOLOGICAL

IPV

administered per protocol

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of Virginia

  lead OTHER

Principal Investigators

• William A Petri, Jr., MD, PhD · University of Virginia

• Mami Taniuchi, PhD · University of Virginia

• K Zaman, MBBS, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

42 Days

Max Age

48 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2016-07-31

Completion

2017-06-30

Countries

• Bangladesh