Mass Oral Cholera Vaccination in Zanzibar
The purpose of this study is to conduct cholera vaccinations in high-risk populations in Zanzibar in order to estimate herd protection conferred by the vaccine,estimate effectiveness of the vaccine, and describe the interaction of vaccination and improved water supply on the burden of cholera and diarrhoeal diseases.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Mass Oral Cholera Vaccination in High-risk Populations in Zanzibar: Assessment of Effectiveness and Herd Protection|
- Receipt of 2 complete or nearly complete swallowed doses of oral cholera vaccine [ Time Frame: after completion of the vaccination campaign ] [ Designated as safety issue: No ]
- Acute, non-bloody diarrhoea severe enough to seek care at the Primary Health Care Units [ Time Frame: starting 10 days following vaccination campaign ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
This is a single arm study. All consenting, eligible participants will receive the oral cholera vaccine.
Biological: rBS-WC vaccine
1 mg of recombinant cholera toxin B subunit and approximately 1 x 10^11 of inactivated whole cells of Vibrio cholerae O1 Inaba and Ogawa, classic and El Tor strains (6). The rBS-WC vaccine is supplied as 3 ml single-dose vials each with a sachet of sodium bicarbonate buffer. Buffer solution will be prepared by dissolving the sachets in drinking water (150 ml water for each sachet of sodium bicarbonate). The full dose of vaccine will be mixed with 40, 75, or 150 ml of buffer solution for persons 2 to 4 years, 5 to 11 years, and over 11 years old, respectively. The vaccine is recommended to be given in two doses with an interval of at least seven days and protection is conferred 7 to 10 days after the second dose.
Other Name: Dukoral™
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00709410
|Ministry of Health and Social Welfare, Zanzibar|
|Principal Investigator:||Ahmed Khatib, MD||Ministry of Health and Social Welfare, Zanzibar|