MedTrace Logo

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

NCT01259453 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 595

Last updated 2010-12-14

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Vaccination to prevent hepatitis B virus infection

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

Sponsors & Collaborators

  • DePaul University

    collaborator OTHER

  • Hispanic Health Council, Inc.

    collaborator OTHER

  • Case Western Reserve University

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Robert Heimer, Ph.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259453 on ClinicalTrials.gov