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Introduction of Cholera Vaccine in Bangladesh (ICVB)

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ClinicalTrials.gov Identifier: NCT01339845
Recruitment Status : Completed
First Posted : April 21, 2011
Last Update Posted : March 7, 2017
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Directorate General of Health Services, Ministry of Health and Family Welfare, Bangladesh
International Vaccine Institute
Dhaka City Corporation, Ministry of Local Government and Rural Development, Bangladesh
School of Public Health and Health Professions, University at Buffalo, USA
Johns Hopkins Bloomberg School of Public Health
University of Maryland, College Park
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information
First Submitted Date  ICMJE April 1, 2011
First Posted Date  ICMJE April 21, 2011
Last Update Posted Date March 7, 2017
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2011)
The number of persons who develop diarrhea due to V. cholerae O1 isolated from their stool. [ Time Frame: Two years after completion of vaccination . ]
The primary analysis will be a comparison of the incidence of primary outcomes in the intervention clusters compared to the non-intervention control clusters.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Introduction of Cholera Vaccine in Bangladesh
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Cholera
Intervention  ICMJE
  • Biological: ShanChol
    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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Vaccine arm
    Thirty clusters (approximately 80,000 people) will receive cholera vaccine alone
    Intervention: Biological: ShanChol
  • Active Comparator: Vaccine plus hygiene and safe water arm
    Thirty clusters (approximately 80,000 people)will receive both cholera vaccine and behaviour change
    Intervention: Behavioral: Vaccine and behaviour
  • No Intervention: Non-intervention arm
    30 neighbourhoods(approximately 80,000 people) will continue their standard habits and practices
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2011)
240000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01339845
Other Study ID Numbers  ICMJE PR-10061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Centre for Diarrhoeal Disease Research, Bangladesh
Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators  ICMJE
  • Bill and Melinda Gates Foundation
  • Directorate General of Health Services, Ministry of Health and Family Welfare, Bangladesh
  • International Vaccine Institute
  • Dhaka City Corporation, Ministry of Local Government and Rural Development, Bangladesh
  • School of Public Health and Health Professions, University at Buffalo, USA
  • Johns Hopkins Bloomberg School of Public Health
  • University of Maryland, College Park
Investigators  ICMJE Not Provided
PRS Account International Centre for Diarrhoeal Disease Research, Bangladesh
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP