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Reactogenicity and immunogenicity of a new recombinant hepatitis B vaccine containing Pre S antigens: a preliminary report
Author(s) -
Hourvitz A.,
Mosseri R.,
Solomon A.,
Yehezkelli Y.,
Atsmon J.,
Da Y. L.,
Koren R.,
Shouval D.
Publication year - 1996
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/j.1365-2893.1996.tb00079.x
Subject(s) - reactogenicity , seroconversion , immunogenicity , medicine , virology , adverse effect , population , chinese hamster ovary cell , antigen , recombinant dna , hepatitis b virus , immunology , virus , biology , pharmacology , biochemistry , receptor , environmental health , gene
SUMMARY. A new vaccine against hepatitis B virus (HBV) infection, produced in mammalian Chinese hamster ovary (CHO) cells, contains the small (s), middle (Pre S2) and large (Pre SI) surface proteins of HBV. Three injections of a 5‐μg or 10‐μg dose were administered intramuscularly (i.m.) at 0, 1 and 6 months to a group of 105 young adults, who were monitored for a period of 6 months after the third injection. Seroconversion rates were 100% after the second injection of the 5‐μg or 10‐μg dose. Geometric mean litres of HBsAb at 1 month after the third injection were 12156 mIU ml ‐1 and 13 482 mIU ml ‐1 in those receiving the 5‐μg and 10‐μg dose respectively. The vaccine was well tolerated with no significant adverse events. These preliminary results suggest that the Pre S‐s recombinant vaccine, produced in mammalian cells, is highly immunogenic, leading to 100% seroconversion in the population tested after injection of only two doses of 5 μg.