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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00841477
First received: February 10, 2009
Last updated: March 12, 2009
Last verified: February 2009
  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
Using Cocaine or Heroin in the Last 7 Days,
Age Over 18 Years Old,
Competent to Sign Informed Consent for HIV/HBV/HCV Testing,
HIV/HBV Negatives Will be Randomized for HB Vaccine Study
HIV Infections
Biological: hepatitis B vaccine schedule
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
Estimated Study Completion Date: June 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 schedule
hepatitis B vaccine: Engerix-B (GlaxoSmithKline) (20 µg/dose) accelerated hepatitis B vaccine schedule (0,1,2month) vs standard hepatitis B vaccine
Other Name: vaccine dose schedules
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; 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 schedule
hepatitis B vaccine: Engerix-B (GlaxoSmithKline) (20 µg/dose) accelerated hepatitis B vaccine schedule (0,1,2month) vs standard hepatitis B vaccine
Other Name: vaccine dose schedules
Behavioral: HBV Vaccination Self-Efficacy Intervention
HB Vaccination Intervention consists of 4 sessions - Sessions 1, 2: at screening and enrollment after intake; 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Lu-Yu Hwang. M.D./Professor of Epidemiology, University of Texas Health Scienter-Houston, School of Public Health
ClinicalTrials.gov Identifier: NCT00841477     History of Changes
Other Study ID Numbers: DESPR DA017505, R01 DA017505-05
Study First Received: February 10, 2009
Last Updated: March 12, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
druguser,hepatitis B vaccine,adherence,immunity,incidence

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis B
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 18, 2014