Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
HVS
2 other identifiers
interventional
595
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2003
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 10, 2010
CompletedFirst Posted
Study publicly available on registry
December 14, 2010
CompletedDecember 14, 2010
December 1, 2010
3.3 years
December 10, 2010
December 13, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vaccine Efficacy
8 months from study enrollment
Secondary Outcomes (2)
Vaccine completion rate
8 months from study enrollment
Association of exchange status with completion
8 months from study enrollment
Study Arms (2)
Standard vaccination schedule
ACTIVE COMPARATORStandard dosing at 0, 1, and 6 months
Accelerated Schedule
ACTIVE COMPARATORAccelerated dosing at 0, 1, and 2 months
Interventions
Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule
Eligibility Criteria
You may qualify if:
- Demonstrate evidence of recent injection drug use (injection stigmata),
- years of age or older,
- Screened for and found susceptible to HBV
- Able to provide informed consent.
You may not qualify if:
- Evidence of intoxication that prevented provision of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- DePaul Universitycollaborator
- Hispanic Health Council, Inc.collaborator
- Case Western Reserve Universitycollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (3)
Hispanic Health Council
Hartford, Connecticut, 06106, United States
DePaul University
Chicago, Illinois, 60614, United States
Case Western Reserve Universtiy
Cleveland, Ohio, 44106, United States
Related Publications (1)
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.
PMID: 18541174RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Heimer, Ph.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 10, 2010
First Posted
December 14, 2010
Study Start
May 1, 2003
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
December 14, 2010
Record last verified: 2010-12