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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2016
• Main ID: NCT00697554
• Date of registration: 12/06/2008
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age
• Scientific 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
• Date of first enrolment: January 2000
• Target sample size: 93
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00697554
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Belgium, France, Germany, Spain, United Kingdom

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis B

Intervention(s)

Biological: HBV-MPL vaccine 208129

Biological: Engerix™-B

Primary Outcome(s)

Anti-HBs antibody concentrations [Time Frame: At Day 28]

Secondary Outcome(s)

Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) [Time Frame: During the study period]

Anti-HBs antibody concentrations [Time Frame: At d21, d28, d56, M6-12, 1M after booster dose]

Occurrence, intensity and relationship to vaccination of unsolicited symptoms [Time Frame: During a 30 day follow-up period after vaccination]

Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms [Time Frame: During a 4 day follow-up period after vaccination]

Secondary ID(s)

208129/036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors