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

History of Changes

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:

MedlinePlus related topics: Cholera Diarrhea

U.S. FDA Resources

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™

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

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):

Khatib AM, Ali M, von Seidlein L, Kim DR, Hashim R, Reyburn R, Ley B, Thriemer K, Enwere G, Hutubessy R, Aguado MT, Kieny MP, Lopez AL, Wierzba TF, Ali SM, Saleh AA, Mukhopadhyay AK, Clemens J, Jiddawi MS, Deen J. Effectiveness of an oral cholera vaccine in Zanzibar: findings from a mass vaccination campaign and observational cohort study. Lancet Infect Dis. 2012 Nov;12(11):837-44. doi: 10.1016/S1473-3099(12)70196-2. Epub 2012 Sep 4.

Hashim R, Khatib AM, Enwere G, Park JK, Reyburn R, Ali M, Chang NY, Kim DR, Ley B, Thriemer K, Lopez AL, Clemens JD, Deen JL, Shin S, Schaetti C, Hutubessy R, Aguado MT, Kieny MP, Sack D, Obaro S, Shaame AJ, Ali SM, Saleh AA, von Seidlein L, Jiddawi MS. Safety of the recombinant cholera toxin B subunit, killed whole-cell (rBS-WC) oral cholera vaccine in pregnancy. PLoS Negl Trop Dis. 2012 Jul;6(7):e1743. Epub 2012 Jul 24.

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:

Cholera
Diarrhea
Vibrio Infections
Gram-Negative Bacterial Infections

Bacterial Infections
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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