Over a decade of experience with a yeast recombinant hepatitis B vaccine

Experience with the yeast recombinant hepatitis B vaccine Engerix(TM)-B now exceeds 10 years. We reviewed published studies on this vaccine. These sho w the vaccine to be safe, causing mostly only minor local symptoms and to b e highly immunogenic both in monitored clinical trials and under field cond itions. Engerix(TM)-B consistently elicits high geometric mean antibody tit res and a high protective efficacy has been established in three groups at high-risk of hepatitis B infection, homosexual men, institutionalised menta lly handicapped subjects and neonates of chronic carrier mothers. The profi le of the recombinant hepatitis B vaccine in certain high-risk groups and i mmune compromised people is discussed. Finally we present updated post mark eting surveillance data based on 496 million distributed doses of vaccine. (C) 1999 Elsevier Science Ltd. All rights reserved.