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

Mass General Brigham

Status

Completed

Conditions

Diarrhea

Cholera

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT02864433

2012P000393

R01AI099243 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

2,207 patients

Sex

All

Ages

12+ months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)

Exclusion criteria for non-cholera diarrhea 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 all controls:

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
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 vaccination campaign)

Exclusion criteria for cholera controls and secondary controls: