Brief Title
Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts
Official Title
Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts
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.
Study Type
Observational
Primary Outcome
cholera-related diarrhea
Secondary Outcome
non-cholera diarrhea
Condition
Cholera
Study Arms / Comparison Groups
Controls for non-cholera diarrhea cases
Description: - Community members that did not have diarrhea between date of study commencement, and time of presentation of the case
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2207
Start Date
October 2012
Completion Date
March 2017
Primary Completion Date
March 2014
Eligibility 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:
- < 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
Gender
All
Ages
12 Months - N/A
Accepts Healthy Volunteers
No
Contacts
Louise C Ivers, MB,BCh,BAO, MPH, ,
Location Countries
Haiti
Location Countries
Haiti
Administrative Informations
NCT ID
NCT02864433
Organization ID
2012P000393
Secondary IDs
R01AI099243
Responsible Party
Principal Investigator
Study Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor
Louise C Ivers, MB,BCh,BAO, MPH, Principal Investigator, Brigham and Women's Hospital
Verification Date
July 2019