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Clinical Trials/NCT01259453
NCT01259453CompletedPhase 4

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

Yale University6 sites in 1 country595 target enrollmentStarted: May 2003Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
595
Locations
6
Primary Endpoint
Vaccine Efficacy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Vaccine Efficacy

Time Frame: 8 months from study enrollment

Secondary Outcomes

  • Vaccine completion rate(8 months from study enrollment)
  • Association of exchange status with completion(8 months from study enrollment)

Investigators

Sponsor Class
Other

Study Sites (6)

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Hepatitis B Vaccination Through Syringe... | Clinical Trial