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

 -  < 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