Female and male pre-dialysis, peritoneal dialysis and haemodialysis patients with documented evidence of nonresponse to previous hepatitis B vaccination [non-response to previous hepatitis B vaccination defined as anti-HBs antibody concentrations <10 mIU/ml after at least one full course (with a minimum of four injections) of licensed vaccine as indicated for uraemic patients].
Conditions
Interventions
Product Name: Hepatitis B surface antigen
Product Code: HB-AS02V
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: HBsAg
Other descriptive name
Sponsors
Henogen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A male or female subject = 15 years of age at the time of the first vaccination. • Written informed consent obtained from the subject/ subject’s parents or guardian. • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. • Seronegative for anti-HBc antibodies and HBsAg at screening. • Pre-dialysis, peritoneal dialysis or haemodialysis patients. Pre-dialysis patient is defined as a patient with a documented creatinine clearance of = 30 ml/min as estimated by the Cockroft-Gault formula. • Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine. The last dose should have been administered at least two months before the planned first dose of study vaccine in this study. • Documented evidence of non-response to previous hepatitis B vaccination (nonresponse defined as anti-HBs antibody =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who have been included in the HN014/HBV-001 study. HN017/HBV-003 Final 18 Nov 2005 21 CARS Id : / Version : 1.16/ Modify Date : 01/02/2005 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 preceding the first dose of study vaccine. • History of hepatitis B infection. • Known exposure to hepatitis B virus within 6 months. • Use of immunoglobulins within six months preceding the first dose of study vaccine. • 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 = 37.5°C (or 37°C in Czech Republic). • Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of HB-AS02V compared to HBVAXPRO® (40 µg) in terms of seroprotection rates (defined as percentage of subjects with anti-HBs antibody concentrations = 10 mIU/ml) achieved at Month 2.;Secondary Objective: To explore the superiority of HB-AS02V vaccine compared to HBVAXPRO® (40 µg) vaccine in terms of seroprotection rates achieved at Month 1. To describe the immunogenicity of HB-AS02V and HBVAXPRO® (40 µg) vaccines at all time points, in terms of anti-HBs seropositivity rate (defined as percentage of subjects with anti-HBs antibody concentrations = 3.3 mIU/ml), seroprotection rates, percentage of subjects with anti-HBs concentrations = 100 mIU/ml and GMCs. To evaluate the safety and reactogenicity of the HBAS02V and HBVAXPRO® (40 µg) vaccines after each dose and per subject.;Primary end point(s): Observed variable • Anti-HBs antibody concentrations at Month 2. Derived variable • Anti-HBs seroprotection (SP) rate at Month 2. | — |
Countries
Belgium, Hungary, Poland
Outcome results
None listed