Introduction of Cholera Vaccine in Bangladesh (ICVB)

I

International Centre for Diarrhoeal Disease Research (icddr,b)

Status

Completed

Conditions

Cholera

Treatments

Biological: ShanChol
Behavioral: Vaccine and behaviour

Study type

Interventional

Funder types

Other

Identifiers

NCT01339845
PR-10061

Details and patient eligibility

About

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.

Full 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.

Enrollment

240,000 patients

Sex

All

Ages

1+ year old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240,000 participants in 3 patient groups

Vaccine arm
Active Comparator group
Description:
Thirty clusters (approximately 80,000 people) will receive cholera vaccine alone
Treatment:
Biological: ShanChol
Vaccine plus hygiene and safe water arm
Active Comparator group
Description:
Thirty clusters (approximately 80,000 people)will receive both cholera vaccine and behaviour change
Treatment:
Behavioral: Vaccine and behaviour
Non-intervention arm
No Intervention group
Description:
30 neighbourhoods(approximately 80,000 people) will continue their standard habits and practices

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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