Hepatitis B
Conditions
Keywords
Hepatitis B, Adjuvanted hepatitis B vaccine
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
Interventions
BIOLOGICALHBV-MPL vaccine 208129
2-dose primary vaccination followed by 1 booster vaccination by intramuscular injection
BIOLOGICALEngerix™-B
3-dose primary vaccination followed by 1 booster vaccination by intramuscular injection of double doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs antibody concentrations | At Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms | During a 4 day follow-up period after vaccination |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms | During a 30 day follow-up period after vaccination |
| Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) | During the study period |
| Anti-HBs antibody concentrations | At d21, d28, d56, M6-12, 1M after booster dose |
Outcome results
None listed