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

NCT00186836 | Completed Phase 4

• 1 other identifier: 2400
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Keywords

Hepatitis A; Hepatitis B; Hemodialysis; Vaccine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

Engerix-B and Twinrix BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Health Care London: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Related Publications (10)

• 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.

  PMID: 14636084 BACKGROUND

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

  PMID: 11349873 BACKGROUND

• 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.

  PMID: 10706965 BACKGROUND

• 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.

  PMID: 8898425 BACKGROUND

• 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.

  PMID: 10590328 BACKGROUND

• 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.

  PMID: 11684316 BACKGROUND

• 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.

  PMID: 1335647 BACKGROUND

• 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.

  PMID: 10924782 BACKGROUND

• 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.

  PMID: 12800994 BACKGROUND

• 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.

  PMID: 20630640 DERIVED

MeSH Terms

Conditions

Hepatitis B; Hepatitis A

Interventions

Engerix-B; twinrix

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections

Study Officials

• Christine H Lee, MD

  St. Joseph's Healthcare and McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2004
• Study Completion: November 1, 2006
• Last Updated: April 20, 2007

Record last verified: 2007-04

Locations

CA (1)