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Mass Oral Cholera Vaccination in Zanzibar

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00709410
First Posted: July 3, 2008
Last Update Posted: March 30, 2012
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.
Collaborators:
Ministry of Health and Social Welfare, Zanzibar
National Institute of Cholera and Enteric Diseases, India
Bill and Melinda Gates Foundation
World Health Organization
Information provided by (Responsible Party):
International Vaccine Institute
  Purpose
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 Intervention
Cholera Diarrhea Biological: rBS-WC vaccine

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

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

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

Enrollment: 51151
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

  Show Detailed Description

  Eligibility

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
Criteria

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


Locations
Tanzania
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
Investigators
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 Submitted: July 1, 2008
First Posted: July 3, 2008
Last Update Posted: March 30, 2012
Last Verified: March 2012

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

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