Overview of a 5-year clinical experience with a yeast-derived hepatitis B vaccine.

Since February 1984, 122 clinical trials have been conducted with a rDNA yeast-derived hepatitis B vaccine (YDV) and plasma-derived vaccines (PDV), involving more than 14,800 individuals. The vaccine has proved safe and well tolerated in all age groups as well as highly immunogenic in both healthy subjects and special target populations. Antibodies elicited by the YDV were qualitatively and quantitatively similar to those induced by PDV. The protective efficacy of the recombinant vaccine has been established in three groups at high risk for hepatitis B infection: the institutionalized mentally handicapped, homosexual males and neonates of carrier mothers. The recombinant vaccine may therefore be considered to be an alternative to PDV and will be invaluable in the control of hepatitis B.