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AzTrials

Hepatitis BPhase 4NCT00186836

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

A Phase 4 study testing Engerix-B and Twinrix in people with Hepatitis B, run by St. Joseph's Health Care London at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hepatitis B
What is being tested?
Engerix-B and Twinrix
How many people
200 participants
Where
1 siteCanada
Study dates
Nov 2004to Nov 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Healthcare

    Hamilton, Ontario

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Hepatitis B
Being tested
Engerix-B and Twinrix
Keywords
Hepatitis A, Hepatitis B, Hemodialysis, Vaccine
Medical subject headings
Hepatitis B, Hepatitis A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Engerix-B and TwinrixBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00186836
Sponsor's protocol ID
2400
Status last verified
Apr 2007
First submitted
13 Sep 2005
Last updated
20 Apr 2007
Results posted
No

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.

    PubMed 14636084

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

    PubMed 11349873

  • 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.

    PubMed 10706965

  • 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.

    PubMed 8898425

  • 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.

    PubMed 10590328

  • 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.

    PubMed 11684316

  • 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.

    PubMed 1335647

  • 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.

    PubMed 10924782

  • 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.

    PubMed 12800994

  • 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.

    PubMed 20630640

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Engerix-B and Twinrix in people with Hepatitis B, run by St. Joseph's Health Care London at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hepatitis B antibody response at month 7 (Significant antibody response defined as anti-HBs Ab greater than or equal to 10mIU/mL ).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00186836, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.

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