Status:
COMPLETED
Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients
Lead Sponsor:
St. Joseph's Health Care London
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Does vaccinating hemodialysis patients with Twinrix® (combination vaccine against hepatitis A and hepatitis B) result in a difference in hepatitis B antibody response in comparison to the monovalent h...
Detailed Description
Hepatitis B virus (HBV) is a human pathogen that causes acute and chronic liver infection. Immunosuppression may be associated with more frequent persistent infection and HBV infections in renal dialy...
Eligibility Criteria
Inclusion
- Hemodialysis patients
- Age greater than or equal to 18
- Able and willing to give informed consent
- Undetectable Anti-HBs Ab level
Exclusion
- Presence of hepatitis BsAg, hepatitis BcAb
- Treatment with IVIg (intravenous immune globulin) within the last 6 months
- Hypersensitivity to components of either vaccine
- Contraindication to intramuscular injections
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00186836
Start Date
November 1 2004
End Date
November 1 2006
Last Update
April 20 2007
Active Locations (1)
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1
St. Joseph's Healthcare
Hamilton, Ontario, Canada