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

Hepatitis B Clinical Trial

— HVS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259453
• Other study ID #: 0005011791
• Secondary ID: 5R01DA014502
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2010
• Last updated: December 13, 2010
• Start date: May 2003
• Est. completion date: August 2006

Study information

• Verified date: December 2010
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Vaccination to prevent hepatitis B virus infection
Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule

Locations

Country	Name	City	State
United States	DePaul University	Chicago	Illinois
United States	Case Western Reserve Universtiy	Cleveland	Ohio
United States	Hispanic Health Council	Hartford	Connecticut

Sponsors (5)

Lead Sponsor	Collaborator
Yale University	Case Western Reserve University, DePaul University, Hispanic Health Council, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine Efficacy		8 months from study enrollment	No
Secondary	Vaccine completion rate		8 months from study enrollment	No
Secondary	Association of exchange status with completion		8 months from study enrollment	No