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

NCT00841477 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1260

Last updated 2017-01-11

No results posted yet for this study

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.

Conditions

  • Hepatitis B Infection
  • Hepatitis C Infection
  • HIV Infection

Interventions

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)

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Lu-Yu Hwang, MD · University of Texas-HSC at Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-06-30
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00841477 on ClinicalTrials.gov