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

NCT ID: NCT02864433

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-03-31

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.

Conditions

Cholera; Diarrhea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Controls for non-cholera diarrhea cases

\- Community members that did not have diarrhea between date of study commencement, and time of presentation of the case

No interventions assigned to this group

Non-cholera diarrhea cases

\- Cases of acute watery diarrhea that present for healthcare at the study sites, but that test negative for cholera

No interventions assigned to this group

Controls for cholera cases

\- Community members that did not have diarrhea between date of study commencement, and time of presentation of the case

No interventions assigned to this group

Cholera cases

\- Those with cholera-related diarrhea who present to healthcare at the study sites.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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).

• 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)

• 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

• < 12 months of age at the time of completion of the cholera vaccine campaign
• Pregnant at the time of the vaccination campaign

• < 12 months of age at the time of completion of the cholera vaccine campaign
• Pregnant at the time of the vaccination campaign

• < 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

• Minimum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Partners in Health

OTHER

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Ministry of Health, Haiti

UNKNOWN

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Louise Ivers, MD

Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise C Ivers, MB,BCh,BAO, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Hopital St Nicholas

Saint-Marc, , Haiti

Countries

Haiti

Other Identifiers

R01AI099243

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012P000393

Identifier Type: -

Identifier Source: org_study_id