NCT01259453|CompletedPhase 4DMC
Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
HVS
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Sponsor study identifier
Secondary identifiers
NIH
interventional
595
1 country
3
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2006
Actual (reported)Study Completion
August 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
August 2006
Actual (reported)August 2006
Actual (reported)December 10, 2010
Actual (reported)December 14, 2010
Actual (reported)Vaccine Efficacy
8 months from study enrollment
Vaccine completion rate
8 months from study enrollment
Association of exchange status with completion
8 months from study enrollment
Standard dosing at 0, 1, and 6 months
Accelerated dosing at 0, 1, and 2 months
Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hispanic Health Council
Hartford, Connecticut, 06106, United States
DePaul University
Chicago, Illinois, 60614, United States
Case Western Reserve Universtiy
Cleveland, Ohio, 44106, United States
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.
Robert Heimer, Ph.D.
Yale University
595 participants (actual enrollment reported by the registry).
First Submitted
December 10, 2010
First Posted
December 14, 2010
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2006
Actual (reported)Study Completion
August 2006
Actual (reported)Last Updated
December 14, 2010
Record last verified: 2010-12
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Source: ClinicalTrials.gov.
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