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Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT00186836
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 20, 2007
Information provided by:
St. Joseph's Healthcare Hamilton

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 hepatitis B vaccine? Hepatitis B infection is an important cause of mortality and morbidity. Current standard vaccination practices have low efficacy levels in patients (eg. hemodialysis patients) who are most susceptible of infection. Efficacy of the two regiments will be studied.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Engerix-B and Twinrix Phase 4

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 dialysis patients can become chronic. The routes of transmission of the virus is well established; direct percutaneous inoculation of virus via exchange of contaminated blood, blood products, body fluids, and hemodialysis. The Center for Diseases Control and Prevention (CDC) recommends immunization in high-risk groups, including hemodialysis patients. Ninety to ninety five percent of healthy, immunocompent adults develop protective anti-hepatitis B surface antibody (anti-HBs) with a primary series of hepatitis B vaccination, but the overall efficacy in renal dialysis patients is much lower. The proportion of hemodialysis patients who develop a seroprotective antibody even with higher doses of vaccination is a median 64% (range: 34-88%).

Reports suggest that combined vaccination of hepatitis B and hepatitis A (Twinrix®: combination vaccine containing inactivated hepatitis A and recombinant hepatitis B) may improve immunogenicity in healthy individuals. In one study, comparing Anti-HBs geometric mean titres (GMT) at month 6 of the series, subjects receiving the combined vaccine showed a statistically significant higher response than those who obtained the monovalent vaccines. Other studies also reflect the same trend at varying points in the vaccination series.

Currently, there are 426 patients in the hemodialysis program at St. Joseph's Healthcare in Hamilton and 324(76%) patients are susceptible to HBV infection.

Our study will determine if the improved immunogenicity observed with combined HAV and HBV vaccine will increase the efficacy of HBV vaccine in hemodialysis patients.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Efficacy of Combined Hepatitis A and Hepatitis B (Twinrix) Vaccine Compared With Hepatitis B Vaccine Alone in Providing Seroprotection Against Hepatitis B in Hemodialysis Patients
Study Start Date : November 2004
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Hepatitis B antibody response at month 7 (Significant antibody response defined as anti-HBs Ab greater than or equal to 10mIU/mL ).

Secondary Outcome Measures :
  1. Anti-HBs geometric mean response at 7 months.
  2. Efficacy of Twinrix® in achieving seroprotection against HAV in hemodialysis patients(Significant antibody response defined as at least 20mIU/mL concentration of anti-HAV.)
  3. Frequency of adverse events associated with vaccine administration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Hemodialysis patients
  • Age greater than or equal to 18
  • Able and willing to give informed consent
  • Undetectable Anti-HBs Ab level

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186836

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Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Sponsors and Collaborators
St. Joseph's Health Care London
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Principal Investigator: Christine H Lee, MD St. Joseph's Healthcare and McMaster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00186836    
Other Study ID Numbers: 2400
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: April 2007
Keywords provided by St. Joseph's Healthcare Hamilton:
Hepatitis A
Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections