Introduction of Cholera Vaccine in Bangladesh (ICVB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01339845|
Recruitment Status : Completed
First Posted : April 21, 2011
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cholera||Biological: ShanChol Behavioral: Vaccine and behaviour||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||240000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Introduction of Cholera Vaccine in Bangladesh: " Impact Evaluation of Cholera Vaccine and Behaviour Change Interventions in Urban Dhaka"|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: Vaccine arm
Thirty clusters (approximately 80,000 people) will receive cholera vaccine alone
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.
Active Comparator: Vaccine plus hygiene and safe water arm
Thirty clusters (approximately 80,000 people)will receive both cholera vaccine and behaviour change
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.
No Intervention: Non-intervention arm
30 neighbourhoods(approximately 80,000 people) will continue their standard habits and practices
- Number of individuals vaccinated with two dose of oral cholera vaccine. [ Time Frame: Six months from initiation of vaccination ]Tergated individuals will be vaccinated and vaccination records will give the coverage.
- Decrease number of cholera cases in intervention arm compared to non-intervention arm. [ Time Frame: Two years after completion of vaccination ]The primary analyses will be comparison of the incidence of primary outcome in the intervention clusters compared to the non-intervention cluster
- Incidence of cholera among vaccinated individuals in vaccination area. [ Time Frame: Two years after completion of vaccination. ]Vaccine-induced protective immunity will be estimated from comparing the incidence of cholera among vaccine recipients in the vaccination area and the incidence of cholera among vaccine non-recipients in the same area.
- Incidence of cholera among non-vaccinated individuals in vaccination area. [ Time Frame: Two years after completion of vaccination ]Indirect protection (herd protection), the protection of non-vaccinated persons due to reduced transmission of an infection, will be estimated from comparing the incidence of cholera among non-vaccinees in the vaccination area and the incidence of cholera in the control area.
- Incidence of cholera in the combined cholera vaccine and behavior change intervention area [ Time Frame: Two years after completion of vaccination ]Assessment of the impact of the combined cholera vaccine and behavior change intervention on the incidence of all diarrheas treated at the ICDDRB and other health facilities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339845
|International Centre for Diarrhoeal Disease Research, Bangladesh|
|Dhaka, Bangladesh, 1212|