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

December 13, 2010 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

595

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hispanic Health Council
    • Illinois
      • Chicago, Illinois, United States, 60614
        • DePaul University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Universtiy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vaccine Efficacy
Time Frame: 8 months from study enrollment
8 months from study enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Vaccine completion rate
Time Frame: 8 months from study enrollment
8 months from study enrollment
Association of exchange status with completion
Time Frame: 8 months from study enrollment
8 months from study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)
Case Western Reserve University
DePaul University
Hispanic Health Council, Inc.

Investigators

  • Principal Investigator: Robert Heimer, Ph.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

December 14, 2010

Last Update Submitted That Met QC Criteria

December 13, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0005011791
  • 5R01DA014502 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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