Hepatitis B
Conditions
Keywords
Hepatitis B vaccination, Syringe exchange programs, Injection drug users, Hepatitis B prevention through vaccination
Brief 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.
Interventions
BIOLOGICALVaccination to prevent hepatitis B virus infection
Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule
Sponsors
DePaul University
Hispanic Health Council, Inc.
Case Western Reserve University
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaccine Efficacy | 8 months from study enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Vaccine completion rate | 8 months from study enrollment |
| Association of exchange status with completion | 8 months from study enrollment |
Countries
United States
Outcome results
None listed