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OpenTrials
Completed

NCT Number: NCT01259453

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hispanic Health Council, Hartford, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaccination to prevent hepatitis B virus infection

Biological

Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule

Primary outcomes

  1. Vaccine Efficacy

    Time frame: 8 months from study enrollment

Secondary outcomes

  1. Vaccine completion rate

    Time frame: 8 months from study enrollment

  2. Association of exchange status with completion

    Time frame: 8 months from study enrollment

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Case Western Reserve University
  • DePaul University
  • Hispanic Health Council, Inc.
  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: HVS

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Dec 14, 2010
Registry last updated
Dec 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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