A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
Phase 3
Completed
- Conditions
- Hepatitis B
- Registration Number
- NCT00291941
- Lead Sponsor
- Henogen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-HBs seroprotection rate at Month 2. Month 0 and 2
- Secondary Outcome Measures
Name Time Method Anti-HBs antibody concentrations Months 0, 1, 2, 3, 6 and 7 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-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 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
Trial Locations
- Locations (24)
O.L.Vrouwziekenhuis Aalst
🇧🇪Aalst, Belgium
RHMS La Madeleine ATH
🇧🇪ATH, Belgium
RHMS Clinique Louis Caty Baudour
🇧🇪Baudour, Belgium
AZ -VUB Dienst Nefrologie
🇧🇪Bruxelles, Belgium
Cliniques universitaires Saint Luc
🇧🇪Bruxelles, Belgium
CHU Brugmann (site V Horta) Service de néphrologie
🇧🇪Bruxelles, Belgium
ULB Hôpital Erasme Département de Néphrologie
🇧🇪Bruxelles, Belgium
CHU Hôpital civil de
🇧🇪Charleroi, Belgium
UZ AntwerpenDienst nefrologie
🇧🇪Edegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
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