Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

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