drugset / Trial / NCT00841477

An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users

NCT00841477

Phase 3 Completed 1260 enrolled National Institute on Drug Abuse (NIDA)
RandomizedFactorialSingle-blindPrevention

Summary

The goal of the proposed study is to use the HBV vaccine as a model for a future HIV vaccine trial, examining the efficacy of community-based outreach intervention as well as an accelerated vaccine schedule as a method for increasing acceptance/adherence with HBV vaccination protocols among not-in-treatment drug users. This study will also examine the effect of HBV vaccination coupled with community-based outreach intervention on reducing the incidence of HIV, HBV and HCV infections and the frequency of needle use and sexual risk behaviors related to these viral transmissions. A secondary purpose will be to assess the antibody response after HBV vaccination as a measurement of immunological response in drug users.

Timeline

Start
2004-01
Primary completion
2007-06
Completion
2009-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Engerix-B Vaccine 20 ug