Skip to main content
OpenTrials
Completed

NCT Number: NCT02864433

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cholera Bacterial Infections Bacterial Infections and Mycoses Diarrhea Gram-Negative Bacterial Infections Infections Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vibrio Infections

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital St Nicholas

Saint-Marc, Haiti

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. cholera-related diarrhea

    Time frame: We will report diarrhea rates at 12 months after the cholera vaccination campaign

    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.

  2. cholera-related diarrhea

    Time frame: We will report diarrhea rates at 24 after the cholera vaccination campaign

    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.

  3. cholera-related diarrhea

    Time frame: We will report diarrhea rates at 60 months after the cholera vaccination campaign

    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.

Secondary outcomes

  1. non-cholera diarrhea

    Time frame: We will report diarrhea rates at 12 months after the cholera vaccination campaign

    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')

  2. non-cholera diarrhea

    Time frame: We will report diarrhea rates at 24 months after the cholera vaccination campaign

    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')

  3. non-cholera diarrhea

    Time frame: We will report diarrhea rates at 60 months after the cholera vaccination campaign

    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')

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • Massachusetts General Hospital
  • Ministry of Health, Haiti
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Partners in Health

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Aug 12, 2016
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.