Hepatitis B
Conditions
Keywords
Dialysis, Pre-dialysis, Hepatitis B vaccine, Prophylaxis
Brief summary
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.
Detailed description
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or GSK Biologicals' adjuvanted hepatitis B vaccine. The study involves a total of 7 visits and blood samples will taken at each of these visits.
Interventions
BIOLOGICALHenogen HBV vaccine
20µg, Month 0, 2 and 6
BIOLOGICALFENDRIX
20 µg,Months 0, 1, 2 and 6
Sponsors
GlaxoSmithKline
Henogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A male or female subject 15 years of age or older at the time of the study entry. * Written informed consent obtained from the subject/ from the parent or guardian of the subject. * Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening. * Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients. * Non-childbearing potential female
Exclusion criteria
* Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Use of any registered vaccine within 7 days before the first dose of study vaccine. * Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine). * History of hepatitis B infection. * Known exposure to hepatitis B virus within 6 months. * Use of immunoglobulins within six months preceding the first study vaccination. * Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed). * Any confirmed or suspected human immunodeficiency virus (HIV) infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/ axillary temperature \< 37.5°C (or 37 °C in Czech Republic). * Oral/axillary temperature superior or equal to 37.5°C (or 37 °C in Czech Republic). * Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs seroprotection rate at Month 2. | Month 0 and 2 |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HBs seroprotection rates for all subjects. | Months 0, 1, 2, 3, 6 and 7 |
| Anti-HBs seropositivity rates for all subjects | Months 0, 1, 2, 3, 6 and 7 |
| Percentage of subjects with anti-HBs antibody concentrations equal or greater than 100 mIU/ml for all subjects. | Months 0, 1, 2, 3, 6 and 7 |
| Anti-HBs geometric mean concentrations calculated for all subjects. | Months 0, 1, 2, 3, 6 and 7 |
| Anti-HBs antibody concentrations | Months 0, 1, 2, 3, 6 and 7 |
| Anti-RF-1 like antibody geometric mean concentration in a random subset of 50 subjects per group. | Month 0 and 7 |
| Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms during a 4-day follow-up (i.e. Day 0 to Day 3) after each vaccination and overall. | Month 0, 1, 2, 3, 6 and 7 |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported during the 31-day (Day 0 to Day 30) follow-up period after each vaccination and overall. | Month 0, 1, 2, 3, 6 and 7 |
| Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 7. | Month 0 to 7 |
| Anti-RF-1 seropositivity rates (defined as the percentage of subjects with anti-RF-1 like antibody concentrations superior or equal to 33 EU/ml, the assay cut-off) in a random subset of 50 subjects per group. | Months 0 and 7 |
Countries
Belgium, Czechia, Hungary
Outcome results
None listed