Trial | NCT01259453  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    595
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.
Study Started
May 31
2003
Primary Completion
Aug 31
2006
Study Completion
Aug 31
2006
Last Update
Dec 14
2010
Estimate

Biological Vaccination to prevent hepatitis B virus infection

Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule

Standard vaccination schedule Active Comparator

Standard dosing at 0, 1, and 6 months

Accelerated Schedule Active Comparator

Accelerated dosing at 0, 1, and 2 months

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.
No Results Posted