NCT00709410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51,151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

1 month

First QC Date

July 1, 2008

Last Update Submit

March 29, 2012

Conditions

CholeraDiarrhea

Keywords

Cholera, Diarrhea, Vaccination, Vaccines

Outcome Measures

Primary Outcomes (1)

  • Receipt of 2 complete or nearly complete swallowed doses of oral cholera vaccine

    after completion of the vaccination campaign

Secondary Outcomes (1)

  • Acute, non-bloody diarrhoea severe enough to seek care at the Primary Health Care Units

    starting 10 days following vaccination campaign

Study Arms (1)

1

EXPERIMENTAL

This is a single arm study. All consenting, eligible participants will receive the oral cholera vaccine.

Biological: rBS-WC vaccine

Interventions

rBS-WC vaccineBIOLOGICAL

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.

Also known as: Dukoral™
1

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age less than 2 years
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health and Social Welfare, Zanzibar

Zanzibar, Tanzania

Location

Related Publications (2)

  • 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.

    PMID: 22954655DERIVED

  • 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;6(7):e1743. doi: 10.1371/journal.pntd.0001743. Epub 2012 Jul 24.

    PMID: 22848772DERIVED

MeSH Terms

Conditions

CholeraDiarrhea

Interventions

Dukoral

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Khatib, MD

    Ministry of Health and Social Welfare, Zanzibar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 3, 2008

Study Start

January 1, 2009

Primary Completion

February 1, 2009

Study Completion

December 1, 2011

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

TA(1)