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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02864433
• Date of registration: 19/05/2014
• Prospective Registration: No
• Primary sponsor: Brigham and Women's Hospital
• Public title: Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts
• Scientific title: Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts
• Date of first enrolment: October 2012
• Target sample size: 2207
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02864433
• Study type: Observational

Countries of recruitment

Haiti

Contacts

• Name: Louise C Ivers, MB,BCh,BAO, MPH
• Affiliation: Brigham and Women's Hospital

Key inclusion & 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:

- < 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



Age minimum: 12 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cholera

Diarrhea

Primary Outcome(s)

cholera-related diarrhea [Time Frame: We will report diarrhea rates at 60 months after the cholera vaccination campaign]

cholera-related diarrhea [Time Frame: We will report diarrhea rates at 12 months after the cholera vaccination campaign]

cholera-related diarrhea [Time Frame: We will report diarrhea rates at 24 after the cholera vaccination campaign]

Secondary Outcome(s)

non-cholera diarrhea [Time Frame: We will report diarrhea rates at 12 months after the cholera vaccination campaign]

non-cholera diarrhea [Time Frame: We will report diarrhea rates at 24 months after the cholera vaccination campaign]

non-cholera diarrhea [Time Frame: We will report diarrhea rates at 60 months after the cholera vaccination campaign]

Secondary ID(s)

R01AI099243

2012P000393

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Harvard Medical School

Partners in Health

Ministry of Health, Haiti

Massachusetts General Hospital

National Institute of Allergy and Infectious Diseases (NIAID)