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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864433
• Other study ID #: 2012P000393
• Secondary ID: R01AI099243
• Status: Completed
• Start date: October 2012
• Est. completion date: March 2017

Study information

• Verified date: July 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2207
• Est. completion date: March 2017
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Cholera
• Diarrhea

Locations

Country	Name	City	State
Haiti	Hopital St Nicholas	St Marc

Sponsors (6)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Harvard Medical School, Massachusetts General Hospital, Ministry of Health, Haiti, National Institute of Allergy and Infectious Diseases (NIAID), Partners in Health

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cholera-related diarrhea	Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours).; 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture.	We will report diarrhea rates at 12 months after the cholera vaccination campaign
Primary	cholera-related diarrhea	Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours).; 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture.	We will report diarrhea rates at 24 after the cholera vaccination campaign
Primary	cholera-related diarrhea	Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours).; 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture.	We will report diarrhea rates at 60 months after the cholera vaccination campaign
Secondary	non-cholera diarrhea	Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours).; 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera')	We will report diarrhea rates at 12 months after the cholera vaccination campaign
Secondary	non-cholera diarrhea	Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours).; 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera')	We will report diarrhea rates at 24 months after the cholera vaccination campaign
Secondary	non-cholera diarrhea	Diarrhea will be determined by clinical criteria for acute watery diarrhea (3 stools in the past 24 hours).; 'Non-cholera' designation will be determined by rapid test for cholera and bacteriologic culture (negative rapid test, culture negative = 'non-cholera')	We will report diarrhea rates at 60 months after the cholera vaccination campaign