Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04

• Published in: Vaccine Vol. 23; no. 3; pp. 316 - 320
• Main Authors: Boland, G., Beran, J., Lievens, M., Sasadeusz, J., Dentico, P., Nothdurft, H., Zuckerman, J.N., Genton, B., Steffen, R., Loutan, L., Hattum, J. Van, Stoffel, M.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 02.12.2004; Elsevier; Elsevier Limited
• Subjects: Adjuvant AS04; Adjuvants, Immunologic - adverse effects; Adolescent; Adult; Aged; Antigens; Applied microbiology; Biological and medical sciences; Female; Fever; Fundamental and applied biological sciences. Psychology; Hepatitis; Hepatitis B - immunology; Hepatitis B Antibodies - biosynthesis; Hepatitis B Antibodies - blood; Hepatitis B vaccine; Hepatitis B Vaccines - adverse effects; Hepatitis B Vaccines - immunology; Human viral diseases; Humans; Immunogenicity; Infections; Infectious diseases; Laboratories; Lipids; Male; Medical sciences; Microbiology; Middle Aged; Pain; Prospective Studies; Radioimmunoassay; Safety; Single-Blind Method; Studies; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Viral diseases; Viral hepatitis; Viral infections; Hepatitis B vaccine; Adjuvant AS04; Safety; Infection; Viral hepatitis B; Immunogenicity; Toxicity; Viral disease; Immunological adjuvant; Digestive diseases; Hepatic disease; Vaccine
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2004.06.006

The reactogenicity and safety of an experimental hepatitis B (HB) vaccine containing adjuvant system (AS04) was compared with a licensed vaccine in a phase III, single-blind, randomised study in healthy volunteers ≥15 years of age. A total of 1303 subjects were enrolled to receive either two doses of HB-AS04 (0, 6 months) or three doses of the comparator vaccine (0, 1, 6 months). Two doses of HB-AS04 elicited seroprotection rates close to 100% and two-fold higher GMTs than the comparator vaccine. Results showed that both vaccines were well tolerated and the general safety profile of HB-AS04 was similar to that of the comparator vaccine.