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Mass Oral Cholera Vaccination in Zanzibar

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: NCT00709410
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : March 30, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Cholera Diarrhea Biological: rBS-WC vaccine

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51151 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mass Oral Cholera Vaccination in High-risk Populations in Zanzibar: Assessment of Effectiveness and Herd Protection
Study Start Date : January 2009
Primary Completion Date : February 2009
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
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™

Outcome Measures

Primary Outcome Measures :
  1. Receipt of 2 complete or nearly complete swallowed doses of oral cholera vaccine [ Time Frame: after completion of the vaccination campaign ]

Secondary Outcome Measures :
  1. Acute, non-bloody diarrhoea severe enough to seek care at the Primary Health Care Units [ Time Frame: starting 10 days following vaccination campaign ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy residents of selected vaccination sites
  • Aged 2 years and older
  • non-pregnant

Exclusion Criteria:

  • Age less than 2 years
  • Pregnant
Contacts and Locations

Information from the National Library of Medicine

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): NCT00709410

Ministry of Health and Social Welfare, Zanzibar
Zanzibar, Tanzania
Sponsors and Collaborators
International Vaccine Institute
Ministry of Health and Social Welfare, Zanzibar
National Institute of Cholera and Enteric Diseases, India
Bill and Melinda Gates Foundation
World Health Organization
Principal Investigator: Ahmed Khatib, MD Ministry of Health and Social Welfare, Zanzibar
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00709410     History of Changes
Other Study ID Numbers: DK - 02
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by International Vaccine Institute:
Cholera, Diarrhea, Vaccination, Vaccines

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs