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

This study has been completed.
Sponsor:
Collaborators:
DePaul University
Hispanic Health Council
Case Western Reserve University
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01259453
First received: December 10, 2010
Last updated: December 13, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Hepatitis B
 Biological: Vaccination to prevent hepatitis B virus infection
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Vaccine Efficacy [ Time Frame: 8 months from study enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaccine completion rate [ Time Frame: 8 months from study enrollment ] [ Designated as safety issue: No ]
  • Association of exchange status with completion [ Time Frame: 8 months from study enrollment ] [ Designated as safety issue: No ]

Enrollment: 595
Study Start Date: May 2003
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Description of the project and results on the website of the Yale Center for Interdisciplinary Research on AIDS  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Robert Heimer, Yale University
ClinicalTrials.gov Identifier: NCT01259453     History of Changes
Other Study ID Numbers: 0005011791, 5R01DA014502
Study First Received: December 10, 2010
Last Updated: December 13, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on June 18, 2013