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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lu-Yu Hwang, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00841477
First received: February 10, 2009
Last updated: April 13, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Hepatitis B Infection
Hepatitis C Infection
HIV Infection
Biological: hepatitis B vaccine 3 dose schedule (0,1,2 month)
Behavioral: HBV Vaccination Self-Efficacy Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • compliance (adherence) for 3 doses hepatitis vaccination [ Time Frame: Jan, 2004 - June 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of HIV and HCV infection and change of risk behaviors [ Time Frame: Jan, 2004- June 2009 ] [ Designated as safety issue: No ]
  • immunological response [ Time Frame: Feb 2004 - June 2008 ] [ Designated as safety issue: No ]

Enrollment: 1260
Study Start Date: January 2004
Study Completion Date: December 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
Active Comparator: B1
enhanced behavioral intervention, standard 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
Active Comparator: B2
enhanced behavioral intervention, accelerated vaccine schedule (0,1,2MONTH)
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00841477

Locations
United States, Texas
University of Texas-HSC at Houston, School of Public Health
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Lu-Yu Hwang, MD University of Texas-HSC at Houston
  More Information

Publications:
Responsible Party: Lu-Yu Hwang, Professor of Epidemiology, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00841477     History of Changes
Other Study ID Numbers: DESPR DA017505
Study First Received: February 10, 2009
Last Updated: April 13, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
druguser,HB vaccine adherence, HBV, HCV, HIV incidence

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Infection
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 25, 2015