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

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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