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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Mount Sinai Hospital, Canada.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Toronto
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01126853
First received: April 15, 2010
Last updated: May 18, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Hepatitis B
Biological: Twinrix
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Protective immunity to Hepatitis B [ Time Frame: up to 7 months (average) ] [ Designated as safety issue: No ]
    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:
  • Adverse Events [ Time Frame: up to 7 months (average) ] [ Designated as safety issue: Yes ]
    The number and description of adverse events.

  • Rate of Recruitment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Partial immunity to Hepatitis B [ Time Frame: up to 7 months (average) ] [ Designated as safety issue: No ]
    The number of patients who develop antibodies against hepatitis B surface antibody at titres of 1-10 IU/ml.


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126853

Contacts
Contact: Todd C Lee, MD 4165864800 ext 5133 todd.lee@utoronto.ca

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

Publications:

Responsible Party: Allison McGeer, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01126853     History of Changes
Other Study ID Numbers: MSH 09-0220-E, R09-15
Study First Received: April 15, 2010
Last Updated: May 18, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Mount Sinai Hospital, Canada:
Immunization
Immunity
Prevention

Additional relevant MeSH terms:
Hepatitis
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

ClinicalTrials.gov processed this record on April 15, 2014