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

Completed

• Conditions: Diarrhea; Cholera

• Registration Number: NCT02864433
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-03
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-12
• Study Completion: 2017-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cholera-related diarrhea	We will report diarrhea rates at 60 months after the cholera vaccination campaign	Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours).; 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture.

Secondary Outcome Measures

Name	Time	Method
non-cholera diarrhea	We will report diarrhea rates at 60 months after the cholera vaccination campaign	Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours).; 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera')

Trial Locations

Locations (1)

Hopital St Nicholas; 🇭🇹 St Marc, Haiti