Diarrhea Clinical Trial
Official title:
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.
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