Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
Information source: Yale University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B
Intervention: Vaccination to prevent hepatitis B virus infection (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Robert Heimer, Ph.D., Principal Investigator, Affiliation: Yale University
Summary
The investigators seek to provide immunization for individuals who are at high risk of
contracting hepatitis B virus (HBV) infection because of their illicit drug use. The
investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport,
CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The
primary purpose of the study is to compare the standard schedule of hepatitis B vaccination
at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The
investigators hypothesize that the accelerated scheduling will result in improved completion
rates without significant loss in vaccine efficacy.
Clinical Details
Official title: Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Vaccine Efficacy
Secondary outcome: Vaccine completion rateAssociation of exchange status with completion
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Demonstrate evidence of recent injection drug use (injection stigmata),
- 18 years of age or older,
- Screened for and found susceptible to HBV
- Able to provide informed consent.
Exclusion Criteria:
- Evidence of intoxication that prevented provision of informed consent.
Locations and Contacts
Hispanic Health Council, Hartford, Connecticut 06106, United States
DePaul University, Chicago, Illinois 60614, United States
Case Western Reserve Universtiy, Cleveland, Ohio 44106, United States
Additional Information
Description of the project and results on the website of the Yale Center for Interdisciplinary Research on AIDS
Starting date: May 2003
Last updated: December 13, 2010
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