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

NCT ID: NCT01259453

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

595 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-08-31

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.

Detailed Description

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Conditions

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Hepatitis B

Keywords

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Hepatitis B vaccination Syringe exchange programs Injection drug users Hepatitis B prevention through vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard vaccination schedule

Standard dosing at 0, 1, and 6 months

Group Type ACTIVE_COMPARATOR

Vaccination to prevent hepatitis B virus infection

Intervention Type BIOLOGICAL

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

Accelerated Schedule

Accelerated dosing at 0, 1, and 2 months

Group Type ACTIVE_COMPARATOR

Vaccination to prevent hepatitis B virus infection

Intervention Type BIOLOGICAL

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

Interventions

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Vaccination to prevent hepatitis B virus infection

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

Intervention Type BIOLOGICAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DePaul University

OTHER

Sponsor Role collaborator

Hispanic Health Council, Inc.

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Yale University

Principal Investigators

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Robert Heimer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Hispanic Health Council

Hartford, Connecticut, United States

Site Status

DePaul University

Chicago, Illinois, United States

Site Status

Case Western Reserve Universtiy

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Hu Y, Grau LE, Scott G, Seal KH, Marshall PA, Singer M, Heimer R. Economic evaluation of delivering hepatitis B vaccine to injection drug users. Am J Prev Med. 2008 Jul;35(1):25-32. doi: 10.1016/j.amepre.2008.03.028.

Reference Type RESULT
PMID: 18541174 (View on PubMed)

Other Identifiers

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5R01DA014502

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0005011791

Identifier Type: -

Identifier Source: org_study_id