Brief Title
Introduction of Cholera Vaccine in Bangladesh
Official Title
Introduction of Cholera Vaccine in Bangladesh: " Impact Evaluation of Cholera Vaccine and Behaviour Change Interventions in Urban Dhaka"
Brief 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.
Detailed Description
Cholera continues to be a major cause of morbidity and mortality in low income countries including Bangladesh. It is estimated that there are at least 300,000 severe cases and 1.2 million infections in people in Bangladesh each year. Deaths annually from cholera may have decreased but overall morbidity remains high. The project for "Introduction of Cholera Vaccine in Bangladesh" (ICVB) will examine the effectiveness of intervention with an oral cholera vaccine in reducing incidence of cholera in urban Dhaka, and the effectiveness of a handwashing and home water treatment behaviour change intervention in reducing diarrhea due to cholera. The proposal involves evaluation of a 2-dose regimen of an oral killed whole cell (WC) vaccine and a handwashing and home water treatment behavior change program promoting improved hygiene and home drinking water treatment in reducing dehydrating diarrhea in a low income area of Dhaka, Bangladesh. The study population will include 90 clusters (neighborhoods) in an area of high cholera incidence in Mirpur with a total study population of 240,000. Thirty clusters (approximately 80,000 people) will receive cholera vaccine alone, 30 clusters will receive both cholera vaccine and behavior change and 30 neighborhoods will continue their standard habits and practices. Surveillance for cholera and diarrhea will be carried out in all the three areas during the whole project period. Following the GIS mapping and census of the target populations, the cholera vaccine will be offered to all males and non-pregnant females aged one year and above in the vaccination areas, and an aggressive hygiene and safe water promotion program will be implemented in the 30 behavior change communication clusters. Passive surveillance for cholera will be undertaken using the two ICDDR,B diarrhea treatment facilities as well as 10 other health facilities that serve the study areas. Vaccine and other public health coverage and costs effectiveness as well cost-benefit will be measured, followed by surveillance and identical follow-up studies. The hygiene and safe water behavior change program will also be continued for 4 years. The impact of interventions will be assessed by following vaccination by directly comparing the incidence of cholera and diarrhea in the intervention communities to the incidence in the standard habits and practices communities.
Study Type
Interventional
Primary Outcome
Number of individuals vaccinated with two dose of oral cholera vaccine.
Secondary Outcome
Incidence of cholera among vaccinated individuals in vaccination area.
Condition
Cholera
Intervention
ShanChol
Study Arms / Comparison Groups
Vaccine arm
Description: Thirty clusters (approximately 80,000 people) will receive cholera vaccine alone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
240000
Start Date
September 2009
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
Inclusion Criteria: 1. Apparently healthy residents of selected vaccination sites 2. Aged 1 year and above 3. Non-pregnant women 4. Written informed consent Exclusion Criteria: 1. Age less than 1 year 2. Pregnant women
Gender
All
Ages
1 Year - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Bangladesh
Location Countries
Bangladesh
Administrative Informations
NCT ID
NCT01339845
Organization ID
PR-10061
Responsible Party
Sponsor
Study Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
Bill and Melinda Gates Foundation
Study Sponsor
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Verification Date
February 2017