Introduction of Cholera Vaccine in Bangladesh

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Cholera
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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