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

Phase 1

Active, not recruiting

• Conditions: 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

• Registration Number: EUCTR2005-004059-37-BE
• Lead Sponsor: Henogen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-15
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

A male or female subject ³above or equal to 15 years of age at the time of the study entry.

Pre-dialysis patients, peritoneal dialysis patients and patients on haemodialysis. Pre-dialysis patients is defined as a subject with a documented creatinine clearance of
less than or equal to 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 ³ 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.

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 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 or 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.

Pregnant or lactating female

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified