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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


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 rate

Association of exchange status with completion


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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