Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules

Completed · Phase 4

Conditions studied: Hepatitis B

In brief

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.

Key facts

Study ID

NCT01259453

Run by

Yale University

People needed

595

Starts

2003-05-01

Expected to finish

2006-08-01

Last updated by the study team

2010-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Evidence of intoxication that prevented provision of informed consent.

Where it is running

• Hispanic Health Council — Hartford, Connecticut, United States
• DePaul University — Chicago, Illinois, United States
• Case Western Reserve Universtiy — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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