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

Phase 4

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Vaccination to prevent hepatitis B virus infection

• Registration Number: NCT01259453
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2010-12
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-13
• Last Update Submitted: 2010-12-13
• Study First Posted: 2010-12-14
• Last Update Posted: 2010-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 595

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.

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Exclusion Criteria

• Evidence of intoxication that prevented provision of informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard vaccination schedule	Vaccination to prevent hepatitis B virus infection	Standard dosing at 0, 1, and 6 months
Accelerated Schedule	Vaccination to prevent hepatitis B virus infection	Accelerated dosing at 0, 1, and 2 months

Primary Outcome Measures

Name	Time	Method
Vaccine Efficacy	8 months from study enrollment

Secondary Outcome Measures

Name	Time	Method
Vaccine completion rate	8 months from study enrollment
Association of exchange status with completion	8 months from study enrollment

Trial Locations

Locations (3)

Hispanic Health Council; 🇺🇸 Hartford, Connecticut, United States

Case Western Reserve Universtiy; 🇺🇸 Cleveland, Ohio, United States

DePaul University; 🇺🇸 Chicago, Illinois, United States