Clinical trial NCT01339845: 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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholera
Keywords: Cholera vaccine
Behaviour change intervention
Cost effectiveness and cost-benefit
Prevention of cholera
Control of Cholera
Vaccination
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Directorate General of Health Services, Ministry of Health and Family Welfare, Bangladesh
name: International Vaccine Institute
name: Dhaka City Corporation, Ministry of Local Government and Rural Development, Bangladesh
name: School of Public Health and Health Professions, University at Buffalo, USA
name: Johns Hopkins Bloomberg School of Public Health
name: University of Maryland
First posted: 2011-04-21
Enrollment: 240000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of individuals vaccinated with two dose of oral cholera vaccine.
timeFrame: Six months from initiation of vaccination
measure: Decrease number of cholera cases in intervention arm compared to non-intervention arm.
timeFrame: Two years after completion of vaccination
Secondary outcomes:
measure: Incidence of cholera among vaccinated individuals in vaccination area.
timeFrame: Two years after completion of vaccination.
measure: Incidence of cholera among non-vaccinated individuals in vaccination area.
timeFrame: Two years after completion of vaccination
measure: Incidence of cholera in the combined cholera vaccine and behavior change intervention area
timeFrame: Two years after completion of vaccination
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
References:
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