CholeraNCT02864433
Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts
An observational study of Cholera and Diarrhea, run by Brigham and Women's Hospital at 1 site in Haiti.
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. Read more about this study
- Who is it for?
- Ages 12 months and older
- How many people
- 2,207 participants
- Where
- 1 siteHaiti
- Study dates
- Oct 2012to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will be conducted in the catchment area of the vaccine campaign, in the rural regions of Bocozel and Grande Saline, located in the Artibonite Department of Haiti. Bocozel has a catchment population of approximately 56,000 people and Grande Saline has a catchment population of approximately 21,000 people. These two neighboring sections are one of two Haitian locations in which the two-dose Shanchol oral cholera vaccine will be implemented as part of the vaccination campaign in 2012. Key stakeholder meetings conducted by PIH staff among diverse groups of community members in Bocozel suggest broad acceptance of the vaccine. Based on these meetings and reported oral cholera vaccine uptake in other countries, we estimate that vaccine uptake will be 80% or higher in Bocozel.
Who may be able to join
- 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
Show all 14Show fewer
- 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 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
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- cholera, oral cholera vaccine, diarrhea
- Medical subject headings
- Cholera, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| Non-cholera diarrhea cases | - Cases of acute watery diarrhea that present for healthcare at the study sites, but that test negative for cholera | |
| Controls for cholera cases | - Community members that did not have diarrhea between date of study commencement, and time of presentation of the case | |
| Cholera cases | - Those with cholera-related diarrhea who present to healthcare at the study sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: We will report diarrhea rates at 12 months after the cholera vaccination campaign
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.
Measured: We will report diarrhea rates at 24 after the cholera vaccination campaign
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.
Measured: We will report diarrhea rates at 60 months after the cholera vaccination campaign
Secondary outcomes (3)
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')
Measured: We will report diarrhea rates at 12 months after the cholera vaccination campaign
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')
Measured: We will report diarrhea rates at 24 months after the cholera vaccination campaign
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')
Measured: We will report diarrhea rates at 60 months after the cholera vaccination campaign
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholeraStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Partners in Health, Harvard Medical School (HMS and HSDM), Massachusetts General Hospital, Ministry of Health, Haiti
- Responsible party
- Principal investigator, Louise Ivers, MD, Brigham and Women's Hospital
- Investigators
- Louise C Ivers, MB,BCh,BAO, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864433
- Sponsor's protocol ID
- 2012P000393
- Other IDs
- R01AI099243
- Status last verified
- Jul 2019
- First submitted
- 19 May 2014
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts
- ClinicalTrials.gov ID
- NCT02864433
- Acronym / sponsor ID
- 2012P000393
- Keywords
- cholera, oral cholera vaccine, diarrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,207 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Partners in Health, Harvard Medical School (HMS and HSDM), Massachusetts General Hospital, Ministry of Health, Haiti
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
| Non-cholera diarrhea cases | – | –- Cases of acute watery diarrhea that present for healthcare at the study sites, but that test negative for cholera |
| Controls for cholera cases | – | –- Community members that did not have diarrhea between date of study commencement, and time of presentation of the case |
| Cholera cases | – | –- Those with cholera-related diarrhea who present to healthcare at the study sites. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be conducted in the catchment area of the vaccine campaign, in the rural regions of Bocozel and Grande Saline, located in the Artibonite Department of Haiti. Bocozel has a catchment population of approximately 56,000 people and Grande Saline has a catchment population of approximately 21,000 people. These two neighboring sections are one of two Haitian locations in which the two-dose Shanchol oral cholera vaccine will be implemented as part of the vaccination campaign in 2012. Key stakeholder meetings conducted by PIH staff among diverse groups of community members in Bocozel suggest broad acceptance of the vaccine. Based on these meetings and reported oral cholera vaccine uptake in other countries, we estimate that vaccine uptake will be 80% or higher in Bocozel.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise C Ivers, MB,BCh,BAO, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholera and Diarrhea, run by Brigham and Women's Hospital at 1 site in Haiti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cholera-related diarrhea (time frame: We will report diarrhea rates at 12 months after the cholera vaccination campaign). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.