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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02864433

Enrollment

2207

Registered

2016-08-12

Start date

2012-10-31

Completion date

2017-03-31

Last updated

2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholera, Diarrhea

Keywords

cholera, oral cholera vaccine, diarrhea

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Months to No maximum

Healthy volunteers

Inclusion criteria

for cholera cases: * 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).

Exclusion criteria

for cholera cases: * \< 12 months of age at the time of completion of the cholera vaccine campaign * Pregnant at the time of the vaccination campaign Inclusion criteria for non-cholera diarrhea cases: * 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)

Design outcomes

Primary

Measure	Time frame	Description
cholera-related diarrhea	We will report diarrhea rates at 12 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

Measure	Time frame	Description
non-cholera diarrhea	We will report diarrhea rates at 12 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')

Countries

Haiti

Outcome results