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

NCT02864433 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2207

Last updated 2019-07-10

No results posted yet for this study

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Partners in Health

    collaborator OTHER

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Ministry of Health, Haiti

    collaborator UNKNOWN

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Louise C Ivers, MB,BCh,BAO, MPH · Brigham and Women's Hospital

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-03-31
Completion
2017-03-31

Countries

  • Haiti

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02864433 on ClinicalTrials.gov