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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Vaccination to prevent hepatitis B virus infection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard vaccination schedule<br>Standard dosing at 0, 1, and 6 months | Biological: Vaccination to prevent hepatitis B virus infection<br>* Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule<br>|
| Active Comparator: Accelerated Schedule<br>Accelerated dosing at 0, 1, and 2 months | Biological: Vaccination to prevent hepatitis B virus infection<br>* Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine Efficacy |  | 8 months from study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine completion rate |  | 8 months from study enrollment | 
| Association of exchange status with completion |  | 8 months from study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B vaccination, Syringe exchange programs, Injection drug users, Hepatitis B prevention through vaccination