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 as a booster dose in pre-dialysis, peritoneal dialysis and haemodialysis subjects (above or equal to 15 years of age) who previously responded to hepatitis B primary vaccination but have lost antibody. - HN018/HBV-004

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

- pre-dialysis patients, peritoneal dialysis patients and patients on haemodialysis. Pre-dialysis 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 licensed vaccine (the cumulative dose for primary vaccination being at least 160 ug of hepatitis B vaccine) with or without subsequent booster. The last primary dose should have been administered at least two months before the planned first dose of study vaccine in this study
- documented response to previous hepatitis B vaccination (anti-HBs concentrations at least 10 mIU/ml) with or without subsequent booster but for whom there is a documented loss of anti-HBs antibody concentrations below 10 mIU/ml at the time of inclusion into the study; patients who have antobody concentration below 50mIU/ml at the inclusion, will also be recruited provided that these antibodies concentration is less than a half of the highest documented antibody response achieved after primary vaccination or booster(s).

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

- patients who have participated in the HNO-HBV-001 or -003 studies
- use of any registered vaccine other than the study vaccine(s) within 7 days preceding the dose of study vaccine, or planned use during the study period.
- 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
- 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)

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 in terms of increase in GMCs from month 0 to month 1;Secondary Objective: To evaluate the safety and reactogenicity of the HB-AS02V vaccine and of HBVAXPRO vaccine;Primary end point(s): - anti-HBs antibody concentrations at Month 0 and Month 1<br>- anti-HBs GMCs at Month 0 and Month 1 on all subjects

Secondary Outcome Measures