Last updated: 11/07/2018 12:57:58

Immunogenicity and safety of a novel adjuvanted HBV vaccine in pre-liver transplant patients 18 years of age

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GSK study ID
208129/036
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Clinicaltrials.gov ID
NCT00697554
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Study to compare the immunogenicity and safety of GSK Biologicals’ novel adjuvanted HBV vaccine (0, 21-day schedule) to a double dose of Engerix™ -B (0, 7, 21-day schedule), in pre-liver transplant patients ≥ 18 y, boosted at month 6-12
Trial description: The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as the control vaccine
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Anti-HBs antibody concentrations

Timeframe: At Day 28

Secondary outcomes:

Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms

Timeframe: During a 4 day follow-up period after vaccination

Occurrence, intensity and relationship to vaccination of unsolicited symptoms

Timeframe: During a 30 day follow-up period after vaccination

Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)

Timeframe: During the study period

Anti-HBs antibody concentrations

Timeframe: At d21, d28, d56, M6-12, 1M after booster dose

Interventions:
  • Biological/vaccine: HBV-MPL vaccine 208129
  • Biological/vaccine: Engerix™-B
    • Enrollment:
    93
    Primary completion date:
    2002-31-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Nevens F et al. (2006) Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients. Liver Transplantation. 12(10):1489-1495.
    Nevens F et al. Immunogenicity and safety of a novel adjuvanted hepatitis B candidate vaccine in liver transplant patients. Abstract presented at the 39th Annual Meeting of the European Association for the Study of Liver (EASL), Berlin, Germany, 14-18 April 2004.
    Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
    Medical condition
    Hepatitis B
    Product
    Hepatitis B Vaccine, Recombinant
    Collaborators
    Not applicable
    Study date(s)
    January 2000 to May 2002
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • A male or female ≥ 18 years of age at the time of the first vaccination.
    • Written informed consent obtained from the subject.
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
    • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A male or female ≥ 18 years of age at the time of the first vaccination.
    • Written informed consent obtained from the subject.
    • Seronegative for anti-HBs-antibodies, anti-HBc-antibodies & HBsAg.
    • If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
    • Documented case of liver failure, such that the patient will require an eventual liver transplant
    Exclusion criteria:
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
    • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
    • Previous vaccination against hepatitis B (whether or not a non-responder to vaccination).
    • Previous vaccination with an adjuvant system containing MPL®.
    • History of hepatitis B infection.
    • Known exposure to hepatitis B virus within 6 weeks.
    • Previously confirmed human immunodeficiency virus (HIV) infection.
    • A family history of congenital or hereditary immunodeficiency.
    • Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
    • Suspected or confirmed multiple sclerosis in the subject (applicable to Centres 011, 012, 013 and 014/ France only).
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • Acute, intercurrent disease at the time of enrollment.
    • Oral/axillary temperature of ≥ 37.5°C (≥ 99.5°F).
    • Administration of immunoglobulins and/or any blood products within one month preceding the first dose of study vaccine or planned administration/ administration during the study period.
    • Pregnant or lactating female

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2002-31-05
    Actual study completion date
    2002-31-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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