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Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules (HVS)

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ClinicalTrials.gov Identifier: NCT01259453
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : December 14, 2010
Sponsor:
Collaborators:
DePaul University
Hispanic Health Council
Case Western Reserve University
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University

Brief Summary:
The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The primary purpose of the study is to compare the standard schedule of hepatitis B vaccination at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The investigators hypothesize that the accelerated scheduling will result in improved completion rates without significant loss in vaccine efficacy.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Vaccination to prevent hepatitis B virus infection Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 595 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
Study Start Date : May 2003
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard vaccination schedule
Standard dosing at 0, 1, and 6 months
Biological: Vaccination to prevent hepatitis B virus infection
Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule

Active Comparator: Accelerated Schedule
Accelerated dosing at 0, 1, and 2 months
Biological: Vaccination to prevent hepatitis B virus infection
Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule




Primary Outcome Measures :
  1. Vaccine Efficacy [ Time Frame: 8 months from study enrollment ]

Secondary Outcome Measures :
  1. Vaccine completion rate [ Time Frame: 8 months from study enrollment ]
  2. Association of exchange status with completion [ Time Frame: 8 months from study enrollment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Demonstrate evidence of recent injection drug use (injection stigmata),
  • 18 years of age or older,
  • Screened for and found susceptible to HBV
  • Able to provide informed consent.

Exclusion Criteria:

  • Evidence of intoxication that prevented provision of informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259453


Locations
United States, Connecticut
Hispanic Health Council
Hartford, Connecticut, United States, 06106
United States, Illinois
DePaul University
Chicago, Illinois, United States, 60614
United States, Ohio
Case Western Reserve Universtiy
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Yale University
DePaul University
Hispanic Health Council
Case Western Reserve University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Robert Heimer, Ph.D. Yale University

Publications of Results:
Responsible Party: Robert Heimer, Yale University
ClinicalTrials.gov Identifier: NCT01259453     History of Changes
Other Study ID Numbers: 0005011791
5R01DA014502 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: December 14, 2010
Last Verified: December 2010

Keywords provided by Yale University:
Hepatitis B vaccination
Syringe exchange programs
Injection drug users
Hepatitis B prevention through vaccination

Additional relevant MeSH terms:
Vaccines
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs