Mass Oral Cholera Vaccination in Zanzibar

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00709410
First received: July 1, 2008
Last updated: March 29, 2012
Last verified: March 2012
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided by International Vaccine Institute

Additional 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
Study First Received: July 1, 2008
Last Updated: March 29, 2012
Health Authority: Zanzibar: Ministry of Health and Social Welfare

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

ClinicalTrials.gov processed this record on September 29, 2014