- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00186836
Efficacy Study of Combined Hepatitis A and Hepatitis B Vaccine to Protect Against Hepatitis B in Hemodialysis Patients
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 Overview
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada
- St. Joseph's Healthcare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Anti-HBs geometric mean response at 7 months.
|
Efficacy of Twinrix® in achieving seroprotection against HAV in hemodialysis patients(Significant antibody response defined as at least 20mIU/mL concentration of anti-HAV.)
|
Frequency of adverse events associated with vaccine administration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine H Lee, MD, St. Joseph's Healthcare and McMaster University
Publications and helpful links
General Publications
- Murdoch DL, Goa K, Figgitt DP. Combined hepatitis A and B vaccines: a review of their immunogenicity and tolerability. Drugs. 2003;63(23):2625-49. doi: 10.2165/00003495-200363230-00008.
- Recommendations for preventing transmission of infections among chronic hemodialysis patients. MMWR Recomm Rep. 2001 Apr 27;50(RR-5):1-43.
- Knoll A, Hottentrager B, Kainz J, Bretschneider B, Jilg W. Immunogenicity of a combined hepatitis A and B vaccine in healthy young adults. Vaccine. 2000 Apr 3;18(19):2029-32. doi: 10.1016/s0264-410x(99)00524-1.
- Leroux-Roels G, Moreau W, Desombere I, Safary A. Safety and immunogenicity of a combined hepatitis A and hepatitis B vaccine in young healthy adults. Scand J Gastroenterol. 1996 Oct;31(10):1027-31. doi: 10.3109/00365529609003124.
- Czeschinski PA, Binding N, Witting U. Hepatitis A and hepatitis B vaccinations: immunogenicity of combined vaccine and of simultaneously or separately applied single vaccines. Vaccine. 2000 Jan 6;18(11-12):1074-80. doi: 10.1016/s0264-410x(99)00354-0.
- Abraham B, Baine Y, De-Clercq N, Tordeur E, Gerard PP, Manouvriez PL, Parenti DL. Magnitude and quality of antibody response to a combination hepatitis A and hepatitis B vaccine. Antiviral Res. 2002 Jan;53(1):63-73. doi: 10.1016/s0166-3542(01)00194-2.
- Ambrosch F, Andre FE, Delem A, D'Hondt E, Jonas S, Kunz C, Safary A, Wiedermann G. Simultaneous vaccination against hepatitis A and B: results of a controlled study. Vaccine. 1992;10 Suppl 1:S142-5. doi: 10.1016/0264-410x(92)90570-a.
- Kallinowski B, Knoll A, Lindner E, Sanger R, Stremmel W, Vollmar J, Zieger B, Jilg W. Can monovalent hepatitis A and B vaccines be replaced by a combined hepatitis A/B vaccine during the primary immunization course? Vaccine. 2000 Aug 15;19(1):16-22. doi: 10.1016/s0264-410x(00)00166-3.
- Lee MB, Middleton D. Enteric illness in Ontario, Canada, from 1997 to 2001. J Food Prot. 2003 Jun;66(6):953-61. doi: 10.4315/0362-028x-66.6.953.
- Tung J, Carlisle E, Smieja M, Kim PT, Lee CH. A randomized clinical trial of immunization with combined hepatitis A and B versus hepatitis B alone for hepatitis B seroprotection in hemodialysis patients. Am J Kidney Dis. 2010 Oct;56(4):713-9. doi: 10.1053/j.ajkd.2010.04.015. Epub 2010 Jul 13.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2400
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis B
-
National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu Chi... and other collaboratorsRecruitingChronic Hepatitis b | Hepatitis B ReactivationTaiwan
-
Mahidol UniversityUnknownChronic Hepatitis B, HBsAg, Hepatitis B VaccineThailand
-
Ain Shams UniversityCompleted
-
Tongji HospitalGilead SciencesRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Changhai HospitalCompleted
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
-
Chong Kun Dang PharmaceuticalCompletedChronic Hepatitis bKorea, Republic of
-
Chong Kun Dang PharmaceuticalUnknownChronic Hepatitis bKorea, Republic of
Clinical Trials on Engerix-B and Twinrix
-
University of CalgaryGlaxoSmithKline; Canadian Institutes of Health Research (CIHR)CompletedVaccine Reaction | Hepatitis B | Non-Alcoholic Fatty Liver DiseaseCanada
-
GlaxoSmithKlineCompletedHepatitis B | Hepatitis AGermany, Belgium
-
GlaxoSmithKlineCompletedHepatitis B | Hepatitis ABelgium, Czechia
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse... and other collaboratorsCompletedHIV Infection | Hepatitis BBrazil, United States, South Africa
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute on Alcohol Abuse... and other collaboratorsCompleted
-
GlaxoSmithKlineCompletedHepatitis B | Hepatitis AGermany, Belgium, Czechia
-
GlaxoSmithKlineCompletedHepatitis B | Hepatitis ABelgium
-
Soroka University Medical CenterCompletedInflammatory Bowel DiseaseIsrael
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingSickle Cell DiseaseNetherlands
-
National Institute of Allergy and Infectious Diseases...Dynavax Technologies CorporationActive, not recruitingHIV Infection | Hepatitis BUnited States, Haiti, Botswana, Philippines, Thailand, Brazil, Kenya, Malawi, South Africa, Uganda, Vietnam