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.

Conditions: Hepatitis B

Summary: 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.

Eligibility criteria:
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

Keywords: dialysis pre-dialysis hepatitis b vaccine prophylaxis hepatitis b infection