Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04.
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 >or=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.
Boland
G
G
Department of Gastroenterology, Universitair Medisch Centrum Utrecht, PB85500, 3508 GA Utrecht, The Netherlands.
Beran
J
J
Lievens
M
M
Sasadeusz
J
J
Dentico
P
P
Nothdurft
H
H
Zuckerman
J N
JN
Genton
B
B
Steffen
R
R
Loutan
L
L
Van Hattum
J
J
Stoffel
M
M
D000276:Adjuvants, Immunologic / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006509:Hepatitis B / Q000276:immunology; D006510:Hepatitis B Antibodies / Q000096:biosynthesis / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011863:Radioimmunoassay; D016037:Single-Blind Method
D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines