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

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Engerix-B and Twinrix

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Christine H Lee, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare and McMaster University

Locations

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St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND

PMID: 14636084 (View on PubMed)

Recommendations for preventing transmission of infections among chronic hemodialysis patients. MMWR Recomm Rep. 2001 Apr 27;50(RR-5):1-43.

Reference Type BACKGROUND

PMID: 11349873 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10706965 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 8898425 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10590328 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11684316 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 1335647 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10924782 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12800994 (View on PubMed)

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.

Reference Type DERIVED

PMID: 20630640 (View on PubMed)

Other Identifiers

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2400

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Interventions

Engerix-B and Twinrix

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

St. Joseph's Health Care London

Principal Investigators

Christine H Lee, MD

Locations

St. Joseph's Healthcare

Countries

References

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.

Other Identifiers

2400