Female and male pre-dialysis, peritoneal dialysis and haemodialysis subjects with documented seroprotection (anti- HBs antibody concentrations = 10 mIU/ml) following previous hepatitis B vaccination (one full course of four injections of licensed vaccine, without any subsequent booster) but for whom antibody concentrations dropped below the seroprotection level.
Conditions
Interventions
Product Name: new adjuvanted Hepatitis B vaccine
Product Code: HB-AS02V
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: HBsAg
Other descript
Sponsors
Henogen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects whom the investigator believes that they 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. • A male or female subject = 15 years of age at the time of the study entry. • Written informed consent obtained from the subject/ subject’s parents or guardians. • Pre-dialysis patients, peritoneal dialysis patients and patients on haemodialysis. Predialysis patients is defined as a subject with a documented creatinine clearance of = 30 ml/min. (as estimated by the Cockroft-Gault formula). • Seronegative for anti-HBc antibodies and for HBsAg at screening. • Documented previous hepatitis B vaccination with one full primary course of four injections of licensed vaccine, without any administration of subsequent booster. The last dose should have been administered at least two months before the planned dose of study vaccine in this study. • Documented response to previous hepatitis B vaccination (anti-HBs = 10 mIU/ml after one full course of four injections of licensed vaccine, without subsequent boosters) but for whom there is a documented loss of anti-HBs antibody concentrations below 10 mIU/ml. • If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used medically-approved 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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: who have participated in the HN014/HBV-001 study. • Use of any investigational or non-registered drug or vaccine within 30 days preceding the study vaccine administration, or planned use during the study period. • Use of any registered vaccine within 7 days preceding the study vaccine administration. • History of hepatitis B infection. • Known exposure to hepatitis B virus within six 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 = 37.5 °C (or 37 °C in Czech Republic). • Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate superiority of HB-AS02V compared to HBVAXPRO® in terms of GMCs achieved at Month 1.;Secondary Objective: • To describe the immunogenicity of HB-AS02V and HBVAXPRO® in terms anti-HBs seropositivity rate (defined as percentage of subjects with anti-HBs antibody concentrations = 3.3 mIU/ml), seroprotection rate (defined as percentage of subjects with anti-HBs antibody concentrations = 10 mIU/ml) and percentage of subjects with anti-HBs antibody concentrations = 100 mIU/ml, at Month 1. • To evaluate the safety and reactogenicity of the HBAS02V vaccine and of HBVAXPRO® after one injection.;Primary end point(s): Observed variable • Anti-HBs antibody concentrations at Month 1. Derived variable • Anti-HBs geometric mean concentrations (GMCs) (calculated on all subjects) at Month 1. | — |
Countries
Czech Republic, Hungary
Outcome results
None listed