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Combination Hepatitis A and B Vaccine to Induce Immunity in Non-responders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01126853
Recruitment Status : Withdrawn
First Posted : May 20, 2010
Last Update Posted : June 1, 2020
University of Toronto
Information provided by (Responsible Party):
Allison McGeer, Mount Sinai Hospital, Canada

Brief Summary:
Hepatitis B is a vaccine preventable infection which can be transmitted through occupational exposure. Approximately 15% of patients will not respond to an initial series of vaccination. Of those re-vaccinated approximately fifty percent will respond. On the basis of poor response to a third series, repeat vaccination is not recommended and non-responders are considered vulnerable to infection. Cardell studied the use of double dose combination hepatitis A and B vaccine (Twinrix) in non responders who had received four or more doses previously and found a high response rate suggesting this vaccine and dose could be effective. The investigators study seeks to duplicate the findings of Cardell, using a more strict definition of non-responder (6 or more previous doses).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study Evaluating the Combination Hepatitis A and B Vaccine (Twinrix®) in Healthy Healthcare Workers Who Meet the CDC Definition for Non-responders.
Study Start Date : April 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vaccination
Receipt of up to 3 series of double dose combination hepatitis A/B vaccine (Twinrix)
Biological: Twinrix
Up to three intramuscular doses of 1cc of Twinrix (combined hepatitis A/B vaccine) at 0, 1, and 6 months post-enrollment

Primary Outcome Measures :
  1. Protective immunity to Hepatitis B [ Time Frame: up to 7 months (average) ]
    The number of patients who develop protective antibody titres (>10 mIU/ml) during the immunization period. This will be followed 1 month after each dose received.

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: up to 7 months (average) ]
    The number and description of adverse events.

  2. Rate of Recruitment [ Time Frame: 1 year ]
    Proportion of subjects who are eligible who agree to participate and who complete the trial. This will be used as a marker of whether a larger trial would be feasible.

  3. Partial immunity to Hepatitis B [ Time Frame: up to 7 months (average) ]
    The number of patients who develop antibodies against hepatitis B surface antibody at titres of 1-10 IU/ml.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry.
  • Available for follow-up during the study period.
  • Has had at least two complete courses of monovalent hepatitis B vaccine, and has documented antiHbS IgG titers of <10mIU/ml within 6 months of completion of the most recent course of vaccination.

Exclusion Criteria:

  • Allergic to any components of the vaccine.
  • Previous serious adverse events associated with the hepatitis B vaccine
  • Received one or more doses of Twinrix in the past
  • Chronic hepatitis B infection, defined as ever having had a positive HBSAg, HBCAb or HepB RNA test
  • Pregnant, or planning to become pregnant during the study period.
  • Received dose of hepatitis B immune globulin, or immune globulin, in last 6 months
  • Immunocompromising condition or therapy that would be expected to reduce the efficacy of vaccination, including:

    1. HIV infection;
    2. lymphoma, multiple myeloma, leukemia or other blood dyscrasia;
    3. systemic lupus erythematosis or other connective tissue disorder;
    4. renal failure (baseline serum creatinine >150uM, or requires dialysis);
    5. nephrotic syndrome;
    6. active neoplastic disease (except localized skin cancer);
    7. any requirement for corticosteroids >20mg/day for >1 week in the six months prior to randomization;
    8. cytotoxic therapy (e.g. chemotherapy for cancer) received within the six months prior to randomization
    9. radiation therapy received in the six months prior to randomization;
    10. hemoglobinopathy;
    11. any immunodeficiency disorder; or
    12. prior solid organ or allogeneic stem cell or bone marrow transplant.
  • Plans to receive cytotoxic therapy or radiation therapy during the study period.

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 identifier (NCT number): NCT01126853

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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1K5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
University of Toronto
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Principal Investigator: Todd C Lee, MD Mount Sinai Hospital, University of Toronto
Principal Investigator: Allison J McGeer, MD MSc Mount Sinai Hospital, University of Toronto

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Responsible Party: Allison McGeer, Professor, Mount Sinai Hospital, Canada Identifier: NCT01126853    
Other Study ID Numbers: MSH 09-0220-E
R09-15 ( Other Grant/Funding Number: PSI Foundation )
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Keywords provided by Allison McGeer, Mount Sinai Hospital, Canada:
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections