Clinical trial NCT00697554: Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B
Adjuvanted hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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

Eligibility 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

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At Day 28
Secondary outcomes:
measure: Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
timeFrame: During a 4 day follow-up period after vaccination
measure: Occurrence, intensity and relationship to vaccination of unsolicited symptoms
timeFrame: During a 30 day follow-up period after vaccination
measure: Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)
timeFrame: During the study period
measure: Anti-HBs antibody concentrations
timeFrame: At d21, d28, d56, M6-12, 1M after booster dose
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Nevens F, Zuckerman JN, Burroughs AK, Jung MC, Bayas JM, Kallinowski B, Rivas EF, Duvoux C, Neuhaus P, Saliba F, Buti M, Zarski JP, Pons F, Vanlemmens C, Hamtiaux V, Stoffel M. Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients. Liver Transpl. 2006 Oct;12(10):1489-95. doi: 10.1002/lt.20836.
citation: 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.
citation: Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.