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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vaccination to prevent hepatitis B virus infection
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B vaccination, Syringe exchange programs, Injection drug users, Hepatitis B prevention through vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hispanic Health Council
  • DePaul University
  • Case Western Reserve Universtiy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard vaccination schedule

Accelerated Schedule

Arm Description

Standard dosing at 0, 1, and 6 months

Accelerated dosing at 0, 1, and 2 months

Outcomes

Primary Outcome Measures

Vaccine Efficacy

Secondary Outcome Measures

Vaccine completion rate
Association of exchange status with completion

Full Information

First Posted
December 10, 2010
Last Updated
December 13, 2010
Sponsor
Yale University
Collaborators
DePaul University, Hispanic Health Council, Inc., Case Western Reserve University, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01259453
Brief Title
Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
Acronym
HVS
Official Title
Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
DePaul University, Hispanic Health Council, Inc., Case Western Reserve University, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B vaccination, Syringe exchange programs, Injection drug users, Hepatitis B prevention through vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
595 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard vaccination schedule
Arm Type
Active Comparator
Arm Description
Standard dosing at 0, 1, and 6 months
Arm Title
Accelerated Schedule
Arm Type
Active Comparator
Arm Description
Accelerated dosing at 0, 1, and 2 months
Intervention Type
Biological
Intervention Name(s)
Vaccination to prevent hepatitis B virus infection
Intervention Description
Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule
Primary Outcome Measure Information:
Title
Vaccine Efficacy
Time Frame
8 months from study enrollment
Secondary Outcome Measure Information:
Title
Vaccine completion rate
Time Frame
8 months from study enrollment
Title
Association of exchange status with completion
Time Frame
8 months from study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Heimer, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hispanic Health Council
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
DePaul University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Case Western Reserve Universtiy
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18541174
Citation
Hu Y, Grau LE, Scott G, Seal KH, Marshall PA, Singer M, Heimer R. Economic evaluation of delivering hepatitis B vaccine to injection drug users. Am J Prev Med. 2008 Jul;35(1):25-32. doi: 10.1016/j.amepre.2008.03.028.
Results Reference
result

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

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