An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users
Completed · Phase 3
Conditions studied: Hepatitis B Infection, Hepatitis C Infection, HIV Infection
In brief
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.
Key facts
- Study ID
- NCT00841477
- Run by
- National Institute on Drug Abuse (NIDA)
- People needed
- 1260
- Starts
- 2004-01-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2017-01-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- using cocaine/heroin in last 7 days, age over 18 years old from two matched in population size, income and demographic communities, known with high rate of drug using and STD; competent to consent for urine drug screening and viral markers (anti-HIV, HBsAg/anti-HBs, anti-HCV) testing; those negative for HIV/HBV will be contacted for HB vaccination study.
You may not qualify if…
- age under 18 or not from the target communities, negative for urine drug test.
Where it is running
- University of Texas-HSC at Houston, School of Public Health — Houston, Texas, United States
Full record on ClinicalTrials.gov
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