Introduction of Cholera Vaccine in Bangladesh

Cholera Clinical Trial

— ICVB  

Official title:

Introduction of Cholera Vaccine in Bangladesh: " Impact Evaluation of Cholera Vaccine and Behaviour Change Interventions in Urban Dhaka"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339845
• Other study ID #: PR-10061
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: March 5, 2017
• Start date: September 2009
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Cholera

Intervention

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.

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (8)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Bill and Melinda Gates Foundation, Dhaka City Corporation, Ministry of Local Government and Rural Development, Bangladesh, Directorate General of Health Services, Ministry of Health and Family Welfare, Bangladesh, International Vaccine Institute, Johns Hopkins Bloomberg School of Public Health, School of Public Health and Health Professions, University at Buffalo, USA, University of Maryland

Country where clinical trial is conducted

Bangladesh, 

References & Publications (2)

Mahalanabis D, Lopez AL, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, Rao R, Holmgren J, Clemens J, Bhattacharya SK. A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India. PLoS One. 2008 Jun 4;3(6):e2323. doi: 10.1371/journal.pone.0002323. — View Citation

Sur D, Lopez AL, Kanungo S, Paisley A, Manna B, Ali M, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Rao R, Nguyen TV, Donner A, Ganguly NK, Nair GB, Bhattacharya SK, Clemens JD. Efficacy and safety of a modified killed-whole-cell oral cholera vaccine in India: an interim analysis of a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2009 Nov 14;374(9702):1694-702. doi: 10.1016/S0140-6736(09)61297-6. Epub 2009 Oct 8. Erratum in: Lancet. 2010 Oct 23;376(9750):1392. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of individuals vaccinated with two dose of oral cholera vaccine.	Tergated individuals will be vaccinated and vaccination records will give the coverage.	Six months from initiation of vaccination
Primary	Decrease number of cholera cases in intervention arm compared to non-intervention arm.	The primary analyses will be comparison of the incidence of primary outcome in the intervention clusters compared to the non-intervention cluster	Two years after completion of vaccination
Secondary	Incidence of cholera among vaccinated individuals in vaccination area.	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.	Two years after completion of vaccination.
Secondary	Incidence of cholera among non-vaccinated individuals in vaccination area.	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.	Two years after completion of vaccination
Secondary	Incidence of cholera in the combined cholera vaccine and behavior change intervention area	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.	Two years after completion of vaccination