A phase III multicentric, multinational, controlled, randomised, open study comparing the immunogenicity, reactogenicity and safety of Henogen’s new adjuvanted hepatitis B vaccine, HB-AS02V, to that of Aventis Pasteur MSD’s hepatitis B vaccine, HBVAXPRO®, administered according to a 0, 1 months schedule, in pre-dialysis, peritoneal dialysis and haemodialysis patients (above or equal to 15 years of age), who did not respond to previous hepatitis B vaccination. - HN017/HBV-003

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

A male or female subject = 15 years of age at the time of the first vaccination.

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 < 10mIU/ml) after at least one to maximum three months after the last vaccine dose.
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

Subjects who have been included in the HN014/HBV-001 study.

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.

Pregnant or lactating female

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the superiority of HB-AS02V compared to HBVAXPRO® (40 µg) in<br>terms of seroprotection rates (defined as percentage of subjects with anti-HBs<br>antibody concentrations = 10 mIU/ml) achieved at Month 2.;Secondary Objective: To explore the superiority of HB-AS02V vaccine compared to HBVAXPRO® (40 µg)<br>vaccine in terms of seroprotection rates achieved at Month 1.<br><br>To describe the immunogenicity of HB-AS02V and HBVAXPRO® (40 µg) vaccines<br>at all time points, in terms of anti-HBs seropositivity rate (defined as percentage of<br>subjects with anti-HBs antibody concentrations = 3.3 mIU/ml), seroprotection rates,<br>percentage of subjects with anti-HBs concentrations = 100 mIU/ml and GMCs.<br><br>To evaluate the safety and reactogenicity of the HB-AS02V and HBVAXPRO® (40<br>µg) vaccines after each dose and per subject.<br>;Primary end point(s): Anti-HBs antibody concentrations at Month 2.<br>Anti-HBs seroprotection (SP) rate at Month 2.

Secondary Outcome Measures