AzTrials
AzTrials

Hepatitis B InfectionPhase 3NCT00841477

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

A Phase 3 study testing hepatitis B vaccine 3 dose schedule (0,1,2 month) and HBV Vaccination Self-Efficacy Intervention in people with Hepatitis B Infection and Hepatitis C Infection, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
hepatitis B vaccine 3 dose schedule (0,1,2 month) and HBV Vaccination Self-Efficacy Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,260 participants
Where
1 siteUnited States
Study dates
Jan 2004to Dec 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • age under 18 or not from the target communities, negative for urine drug test.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas-HSC at Houston, School of Public Health

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the 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.

Being tested
hepatitis B vaccine 3 dose schedule (0,1,2 month), HBV Vaccination Self-Efficacy Intervention
Keywords
druguser,HB vaccine adherence, HBV, HCV, HIV incidence
Medical subject headings
Hepatitis B, Hepatitis C, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hepatitis B vaccine 3 dose schedule (0,1,2 month)Biological

    Also called accelerated HB vaccine schedule

    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)

  • HBV Vaccination Self-Efficacy InterventionBehavioural

    Also called enhanced behavioral 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

Study groups in NCT00841477
Study groupRoleWhat they receive
A1No interventionstandard behavioral intervention, standard HB vaccine schedule (0,1,6month)
A2Active comparatorstandard behavioral intervention, accelerated HB vaccine schedule (0,1,2month)
Receives: Biological: hepatitis B vaccine 3 dose schedule (0,1,2 month)
B1Active comparatorenhanced behavioral intervention, standard vaccine schedule
Receives: Behavioral: HBV Vaccination Self-Efficacy Intervention
B2Active comparatorenhanced behavioral intervention, accelerated vaccine schedule (0,1,2MONTH)
Receives: Biological: hepatitis B vaccine 3 dose schedule (0,1,2 month); Behavioral: HBV Vaccination Self-Efficacy Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. compliance (adherence) for 3 doses hepatitis vaccination

    Measured: Jan, 2004 - June 2008

Secondary outcomes (2)

  1. incidence of HIV and HCV infection and change of risk behaviors

    Measured: Jan, 2004- June 2009

  2. immunological response

    Measured: Feb 2004 - June 2008

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2009 (estimated)
  2. Study startJan 2004
  3. Primary completionJun 2007
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00841477
Sponsor's protocol ID
DESPR DA017505
Status last verified
Apr 2015
First submitted
10 Feb 2009
Last updated
11 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20936979

  • Tran 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.

    PubMed 22075088

  • Shah 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.

    PubMed 22170543

  • Grimes 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.

    PubMed 23152368

  • Kamath 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.

    PubMed 24631093

  • Lu-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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hepatitis B vaccine 3 dose schedule (0,1,2 month) and HBV Vaccination Self-Efficacy Intervention in people with Hepatitis B Infection and Hepatitis C Infection, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compliance (adherence) for 3 doses hepatitis vaccination (time frame: Jan, 2004 - June 2008). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00841477, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.

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