Introduction of Cholera Vaccine in Bangladesh

Summary

The purpose of this study is to conduct and evaluate the feasibility and effectiveness of a mass cholera vaccination program to reduce diarrhea due to Vibrio cholerae in a high incidence urban area. This study will also evaluate the feasibility of adding a household hand washing and safe drinking water promotion intervention to a cholera vaccine program and the overall impact of this combination on decreasing the incidence of diarrhea due to Vibrio cholerae.

Conditions

• Cholera

Interventions

BIOLOGICAL

ShanChol

Each dose of the vaccine contains whole cell Killed inactivated V.cholerae O1 and O139 strains.Vaccine is packaged as liquid formulations in 1.5-ml doses. The vaccine is given two doses separated by a two week interval and administered orally.

BEHAVIORAL

Vaccine and behaviour

Together with vaccination the community health worker will offer a hand washing station and water treatment facilities that include both hardware and a software component. The idea of the handwashing station is to bring together with soap and water that people need for handwashing, especially for handwashing after defecation. The hardware for water treatment is a chlorine dispenser that is a reservoir which holds sodium hypochlorite and dispenses a measured dose of the dilute sodium hypochlorite into a 15 liter water tank. Community residents can collect water directly from the 15 L water tanks into their own personal water storage vessels. The community health worker will negotiate with compound residents for the development of a water treatment system.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Directorate General of Health Services, Ministry of Health and Family Welfare, Bangladesh

  collaborator UNKNOWN

• International Vaccine Institute

  collaborator OTHER

• Dhaka City Corporation, Ministry of Local Government and Rural Development, Bangladesh

  collaborator UNKNOWN

• School of Public Health and Health Professions, University at Buffalo, USA

  collaborator UNKNOWN

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2016-12-31

Completion

2016-12-31

Countries

• Bangladesh

Study Locations