Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts

NCT02864433•Brigham and Women's Hospital

Summary

The investigators aim to evaluated a public health program in Haiti that introduced an oral cholera vaccine as part of comprehensive control efforts for a major cholera epidemic. Although the vaccine (Shanchol(R)) had been demonstrated to be very safe, and effective at preventing cholera in many settings, it had not extensively been used to control an outbreak, and it had not been extensively studied in populations that were previously naive to cholera (i.e. countries that had never had cholera before). This cholera epidemic was the first ever report of cholera in Haiti. After the cholera vaccination campaign was complete, the investigators aimed to evaluate the field efficacy of the vaccination campaign by evaluating the number of cases of cholera, and determining if cholera patients had been vaccinated. The investigators compared the rate of vaccination in cholera cases to controls from the community that had not had cholera in a case-control study. The investigators also performed a second study - a bias-indicator study - that enrolled patients with non-cholera diarrhea, and community controls. The role of the bias-indicator study was to evaluate for potential sources of bias, since the investigators could expect that cholera vaccination should have no effect on non-cholera diarrhea.

Eligibility

Age

1 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Seeks treatment for acute non-bloody diarrhea (defined as 3 or more loose, watery or liquid stools in a 24-hour period with an onset of 3 days or fewer prior to presentation) at a participating study site
•Diarrhea episode is diagnosed as cholera, confirmed by Crystal VC rapid test and culture
•Resident of Bocozel or Grande Saline at the time of study initiation
•Was eligible for the vaccination campaign (i.e. ≥ 12 months of age at the time of completion of the vaccine campaign, not pregnant during the vaccination campaign).
•Seeks treatment for acute non-bloody diarrhea (as defined above) at a participating study site
•Culture negative cholera by Crystal VC rapid test and culture
•Resident of Bocozel or Grande Saline at the time of study initiation
•Was eligible for the vaccination campaign (≥ 12 months of age at the time of completion of the vaccine campaign, not pregnant at the time of the campaign)
•Did not seek treatment for diarrhea between the date that study enrollment began and corresponding case's symptom onset (defined below)
•Resident of Bocozel or Grande Saline at the time of study initiation
+1 more criteria

Exclusion Criteria

•\< 12 months of age at the time of completion of the cholera vaccine campaign
•Pregnant at the time of the vaccination campaign
•\< 12 months of age at the time of completion of the cholera vaccine campaign
•Pregnant at the time of the vaccination campaign
•\< 12 months of age at the time of completion of the cholera vaccine campaign
•Pregnant at the time of completion of the cholera vaccine campaign

Locations (1)

Hopital St Nicholas

Saint-Marc, Haiti

Key Dates

Start Date

October 1, 2012

Primary Completion Date

March 1, 2014

Completion Date

March 1, 2017

Last Updated

July 10, 2019

Enrollment

2,207

ACTUAL participants

Conditions

CholeraDiarrhea

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Clostridium DifficileClostridium Difficile Infections+8 more

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RECRUITINGPHASE3

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

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Carcinoid SyndromeCarcinoid+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts

Inclusion Criteria

Exclusion Criteria

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

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Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance