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

Yale University

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Biological: Vaccination to prevent hepatitis B virus infection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01259453

5R01DA014502 (U.S. NIH Grant/Contract)

0005011791

Details and patient eligibility

About

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.

Enrollment: 595 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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595 participants in 2 patient groups

Standard vaccination schedule

Active Comparator group

Description:

Standard dosing at 0, 1, and 6 months

Treatment:

Biological: Vaccination to prevent hepatitis B virus infection

Accelerated Schedule

Active Comparator group

Description:

Accelerated dosing at 0, 1, and 2 months

Treatment:

Biological: Vaccination to prevent hepatitis B virus infection