Hepatitis B
Conditions
Keywords
Hepatitis B, Engerix™-B, Recombinant Hepatitis B vaccine, Adjuvant
Brief summary
The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population
Detailed description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Interventions
BIOLOGICALRecombinant MPL- adjuvanted hepatitis B vaccine
Intramuscular injection, 3 doses
BIOLOGICALEngerix™-B
Intramuscular injection, 3 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age: older than 18 years of age. * Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine * Good physical condition as established by clinical examination and history taking at the time of entry. * Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. * Written informed consent obtained from the subjects
Exclusion criteria
* Positive at screening for anti-HBV antibodies * Elevated serum liver enzymes. * History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * Any acute disease at the moment of entry. * Chronic alcohol consumption. * Hepatomegaly, right upper quadrant abdominal pain or tenderness. * Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. * History of allergic disease likely to be stimulated by any component of the vaccine. * Simultaneous participation in any other clinical trial. * Previous vaccination with an MPL containing vaccine. * Administration of immunoglobulins 6 months before and during the whole study period * Vaccination one month before and one month after each dose of the study vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs antibody concentrations | At month 7 |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HBs antibody concentrations | At months 2, 6, 7 and 12 |
| Occurrence and intensity of solicited local symptoms | 4-day follow-up after vaccination |
| Occurrence, intensity and relationship of solicited general symptoms | 4-day follow-up after vaccination |
| Incidence of serious AEs | Throughout the entire study up to and including 30 days after the last vaccination |
| Cell mediated immunity | At months 0, 2, 6, 7, 12 |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms | Within 30 days after vaccination |
Countries
Belgium
Outcome results
None listed