A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.
The immune response of uraemic patients to hepatitis B vaccination is impaired compared to
 healthy subjects. After vaccination, anti-HBs peak antibody concentrations are reduced. As
 the persistence of anti-HBs is closely related to the initial anti-HBs peak, a more
 immunogenic vaccine, allowing higher antibody concentrations, would be a benefit for this
 population.
Study participants will receive either Henogen's adjuvanted hepatitis B vaccine or Aventis
 Pasteur's hepatitis B vaccine. The study involves a total of 3 visits and blood samples will
 taken at each of these visits.
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 or older 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.
 Pre-dialysis patients is defined as a subject with a documented creatinine clearance
 of les or equal to 30 ml/min.

 -  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 is at least 160 mg of hepatitis B
 vaccine) with or without subsequent boosters. The last dose should have been
 administered at least three months before the planned dose of study vaccine in this
 study.

 -  Documented response to previous hepatitis B vaccination (i.e. anti-HBs antibody
 concentrations ³ 10 mIU/ml after primary vaccination or after booster/s with licensed
 vaccine), but for whom there is a loss of anti-HBs antibody concentrations below 10
 mIU/ml at the time of inclusion into the study. Patients who have antibody
 concentrations below 50 mIU/ml at the time of inclusion will also be recruited
 provided that this antibody concentration is less than half of the highest documented
 antibody response achieved after primary vaccination or booster/s. The interval
 between the blood sample corresponding to the documented response and the hepatitis B
 vaccine dose received prior to this blood sample should be at least 25 days

 -  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.

 Exclusion Criteria:

 -  Subjects who have participated in the HN014/HBV-001 or HN017/HBV-003 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 equal or superior to 37.5 °C (or 37 °C in Czech Republic).

 -  Pregnant or lactating female