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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00841477
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
, National Institute on Drug Abuse (NIDA)

February 10, 2009
February 11, 2009
January 11, 2017
January 2004
June 2007   (Final data collection date for primary outcome measure)
compliance (adherence) for 3 doses hepatitis vaccination [ Time Frame: Jan, 2004 - June 2008 ]
Same as current
Complete list of historical versions of study NCT00841477 on Archive Site
  • incidence of HIV and HCV infection and change of risk behaviors [ Time Frame: Jan, 2004- June 2009 ]
  • immunological response [ Time Frame: Feb 2004 - June 2008 ]
Same as current
Not Provided
Not Provided
An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users
An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users
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.
This project will evaluate an HBV vaccination program as a model for future HIV vaccine efficacy trials in a community-based study of drug users. Two components will be analyzed in an effort to increase vaccine acceptance/adherence - behavioral intervention & an accelerated vaccine schedule. The study also will examine the effect of these variables on risk behaviors and incidence of HIV, HBV, & HCV infections. To accomplish these objectives, we propose a randomized behavioral intervention field trial. We will enroll 1600 current cocaine or heroin users negative for HBV & HIV markers from two closely matched, low-income, high drug endemic communities in Houston. All participants will be offered HBV vaccination and follow-up viral testing. One community will be randomly assigned to receive an outreach behavioral intervention designed to increase vaccine awareness and vaccine compliance. The other community will receive standard care. Participants electing to be vaccinated will be randomized to either a 0,1,6 month or a 0,1,2, month vaccine schedule. Groups will be followed for two years to determine rates of HBV vaccine acceptance/adherence to the 3-dose protocol. We also will measure any changes in risk behaviors & incidence of HIV/HBV/HCV infections as well as HBV vaccine immune response, if vaccinated. Drug users are the largest group of newly diagnosed HIV cases and so creating a model for an HIV vaccine's acceptance and adherence in this population is an important public health goal. This study will serve as a model for future HIV vaccine trials and will provide information on the effectiveness of outreach programs for increasing immunization among drug users. Unless an effective model based upon empirical experience is developed, any attempt to implement a HIV vaccination program among drug users is likely to be frustrated. If HBV vaccination coupled with outreach intervention can reduce risk behaviors and decrease the incidence of HIV/HCV infection, then this study will have a tremendous impact on the current HBV/HIV/HCV prevention strategy.
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Hepatitis B Infection
  • Hepatitis C Infection
  • HIV Infection
  • Biological: hepatitis B vaccine 3 dose schedule (0,1,2 month)
    hepatitis B (HB) vaccine: Engerix-B (GlaxoSmithKline) (20 µg/dose) accelerated HB vaccine schedule (0,1,2 month),vs, standard HB vaccine schedule (0,1,6 m)
    Other Name: accelerated HB vaccine schedule
  • Behavioral: HBV Vaccination Self-Efficacy Intervention
    HB Vaccination Intervention consists of 4 sessions - Sessions 1, 2: at screening and enrollment after intake, vs regular risk reduction education Sessions 3, 4: coincide with the vaccination schedule ions 4 before 3rd dose
    Other Name: enhanced behavioral intervention
  • No Intervention: A1
    standard behavioral intervention, standard HB vaccine schedule (0,1,6month)
  • Active Comparator: A2
    standard behavioral intervention, accelerated HB vaccine schedule (0,1,2month)
    Intervention: Biological: hepatitis B vaccine 3 dose schedule (0,1,2 month)
  • Active Comparator: B1
    enhanced behavioral intervention, standard vaccine schedule
    Intervention: Behavioral: HBV Vaccination Self-Efficacy Intervention
  • Active Comparator: B2
    enhanced behavioral intervention, accelerated vaccine schedule (0,1,2MONTH)
    • Biological: hepatitis B vaccine 3 dose schedule (0,1,2 month)
    • Behavioral: HBV Vaccination Self-Efficacy Intervention

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2009
June 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • age under 18 or not from the target communities, negative for urine drug test.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
DESPR DA017505
Not Provided
Not Provided
, National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Lu-Yu Hwang, MD University of Texas-HSC at Houston
National Institute on Drug Abuse (NIDA)
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP