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

Henogen0 个研究点目标入组 120 人开始时间: 2005年12月5日最近更新: 2012年3月19日

试验速览

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•- 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

•- 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)

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