Trial record 7 of 8 for:    handwashing [CONDITION] OR handwashing [TREATMENT] | Open Studies

Introduction of Cholera Vaccine in Bangladesh (ICVB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by International Centre for Diarrhoeal Disease Research, Bangladesh
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
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01339845
First received: April 1, 2011
Last updated: June 5, 2013
Last verified: April 2011
  Purpose

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.


Condition Intervention
Cholera
Biological: ShanChol
Behavioral: Vaccine and behaviour

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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"

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Number of individuals vaccinated with two dose of oral cholera vaccine. [ Time Frame: Six months from initiation of vaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The primary analyses will be comparison of the incidence of primary outcome in the intervention clusters compared to the non-intervention cluster


Secondary Outcome Measures:
  • Incidence of cholera among vaccinated individuals in vaccination area. [ Time Frame: Two years after completion of vaccination. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 240000
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vaccine arm
Thirty clusters (approximately 80,000 people) will receive cholera vaccine alone
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.
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

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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339845

Contacts
Contact: Firdausi Qadri, PhD +88-02-8860525 ext 2431 fqadri@icddrb.org

Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh Recruiting
Dhaka, Bangladesh, 1212
Contact: Firdausi Qadri, PhD    88-02-8860525-32 ext 2431    fqadri@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01339845     History of Changes
Other Study ID Numbers: PR-10061
Study First Received: April 1, 2011
Last Updated: June 5, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Cholera vaccine
Behaviour change intervention
Cost effectiveness and cost-benefit
Prevention of cholera
Control of Cholera
Vaccination

Additional relevant MeSH terms:
Cholera
Bacterial Infections
Gram-Negative Bacterial Infections
Vibrio Infections

ClinicalTrials.gov processed this record on October 29, 2014