An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users
1 other identifier
interventional
1,260
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2004
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 10, 2009
CompletedFirst Posted
Study publicly available on registry
February 11, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 11, 2017
April 1, 2015
3.4 years
February 10, 2009
January 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
compliance (adherence) for 3 doses hepatitis vaccination
Jan, 2004 - June 2008
Secondary Outcomes (2)
incidence of HIV and HCV infection and change of risk behaviors
Jan, 2004- June 2009
immunological response
Feb 2004 - June 2008
Study Arms (4)
A1
NO INTERVENTIONstandard behavioral intervention, standard HB vaccine schedule (0,1,6month)
A2
ACTIVE COMPARATORstandard behavioral intervention, accelerated HB vaccine schedule (0,1,2month)
B1
ACTIVE COMPARATORenhanced behavioral intervention, standard vaccine schedule
B2
ACTIVE COMPARATORenhanced behavioral intervention, accelerated vaccine schedule (0,1,2MONTH)
Interventions
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)
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
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas-HSC at Houston, School of Public Health
Houston, Texas, 77030, United States
Related Publications (6)
Hwang LY, Grimes CZ, Tran TQ, Clark A, Xia R, Lai D, Troisi C, Williams M. Accelerated hepatitis B vaccination schedule among drug users: a randomized controlled trial. J Infect Dis. 2010 Nov 15;202(10):1500-9. doi: 10.1086/656776. Epub 2010 Oct 11.
PMID: 20936979RESULTTran TQ, Grimes CZ, Lai D, Troisi CL, Hwang LY. Effect of age and frequency of injections on immune response to hepatitis B vaccination in drug users. Vaccine. 2012 Jan 5;30(2):342-9. doi: 10.1016/j.vaccine.2011.10.084. Epub 2011 Nov 8.
PMID: 22075088RESULTShah DP, Grimes CZ, Brown E, Hwang LY. Demographics, socio-behavioral factors, and drug use patterns: what matters in spontaneous HCV clearance? J Med Virol. 2012 Feb;84(2):235-41. doi: 10.1002/jmv.22271.
PMID: 22170543RESULTGrimes CZ, Hwang LY, Wei P, Shah DP, Volcik KA, Brown EL. Differentially regulated gene expression associated with hepatitis C virus clearance. J Gen Virol. 2013 Mar;94(Pt 3):534-542. doi: 10.1099/vir.0.047738-0. Epub 2012 Nov 14.
PMID: 23152368RESULTKamath GR, Shah DP, Hwang LY. Immune response to hepatitis B vaccination in drug using populations: a systematic review and meta-regression analysis. Vaccine. 2014 Apr 25;32(20):2265-74. doi: 10.1016/j.vaccine.2014.02.072. Epub 2014 Mar 12.
PMID: 24631093RESULTLu-Yu. Hwang*, Carolyn. Grimes "Human Immunodeficiency Virus, hepatitis B and C Virus infections among injecting and non-injecting drug users from inner city neighborhoods " Insight and Control of Infectious Disease in Global Scenario, Priti Kumar Roy (Ed), ISBN 978-953-51-0319-6, 2012, p45-60 InTech, Available from http://www.intechopen.com/articles/show/title/immunodeficiency-virus-hepatitis-b-and-hepatitis-c-virus-infections-among-injecting-and-non-injectin
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lu-Yu Hwang, MD
University of Texas-HSC at Houston
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Epidemiology
Study Record Dates
First Submitted
February 10, 2009
First Posted
February 11, 2009
Study Start
January 1, 2004
Primary Completion
June 1, 2007
Study Completion
December 1, 2009
Last Updated
January 11, 2017
Record last verified: 2015-04