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: 240

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

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