title: A hepatitis B vaccine formulated with a novel adjuvant system.
abstract: Although more than 95% of the vaccinated population responds to the currently licensed vaccines against hepatitis B, some groups were found to be low responders. Lipid A as adjuvant, through its ability to activate macrophages, might improve humoral as well as cellular immune response. Therefore we evaluated the profile of a hepatitis B vaccine with the new adjuvant system SBAS4. 150 young adults were enrolled and randomized into three groups: one received the SBAS4 hepatitis B vaccine, the second Engerix-B(TM) and the third a hepatitis B vaccine with an alternative formulation on alum. Vaccinations were at 0 and 6 months. The vaccine was well tolerated. At month 7 all vaccinees were protected but with significant differences in GMTs between groups: 13,271 mIU/ml for the SBAS4 group versus 1203 and 1823 mIU/ml. Hence the hepatitis B vaccine with the new adjuvant system is more immunogenic compared to the other vaccines containing the same antigen and could be suitable for a two dose schedule.
authors.affiliation: Institute for Specific Prophylaxis and Tropical Medicine, University of Vienna, Kinderspitalgasse 15, A-1095, Wien, Austria.
authors.forename: F
authors.initials: F
authors.lastname: Ambrosch
authors.forename: G
authors.initials: G
authors.lastname: Wiedermann
authors.forename: M
authors.initials: M
authors.lastname: Kundi
authors.forename: G
authors.initials: G
authors.lastname: Leroux-Roels
authors.forename: I
authors.initials: I
authors.lastname: Desombere
authors.forename: N
authors.initials: N
authors.lastname: Garcon
authors.forename: C
authors.initials: C
authors.lastname: Thiriart
authors.forename: M
authors.initials: M
authors.lastname: Slaoui
authors.forename: S
authors.initials: S
authors.lastname: Thoelen
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000534:Alum Compounds / Q000009:adverse effects; D004311:Double-Blind Method; D004487:Edema / Q000209:etiology; D005221:Fatigue / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000209:etiology; D006510:Hepatitis B Antibodies / Q000096:biosynthesis / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular; D007117:Immunization, Secondary / Q000009:adverse effects; D008050:Lipid A / Q000009:adverse effects; D008213:Lymphocyte Activation; D008297:Male; D010146:Pain / Q000209:etiology; D012449:Safety; D016036:Seroepidemiologic Studies; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D000534:Alum Compounds; C075654:Engerix-B; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D008050:Lipid A; C410283:SBAS4 adjuvant system; D014614:Vaccines, Synthetic; C041524:aluminum sulfate