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
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, see Learn About Clinical Studies.

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 August 28, 2014