Euvax-B Mechanism of Action

Pharmacology: Pharmacodynamics: Higher antibody titers and lower ED₅₀ values were observed with Euvax-B in mice than with plasma-derived HBsAg and also higher antibody titers than with commercially available rHBsAg in a comparison test to assess the potency of Euvax-B (see Tables 1 and 2).

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Relevant information for Euvax-B: In order to evaluate the immunogenicity and safety of recombinant DNA yeast-derived hepatitis B vaccine (Euvax-B) by administration at intervals of 0-, 1- and 2-months and 0-, 1-, and 6-months and to compare the antibody titres after vaccination by a plasma-derived HBV vaccine with that by the recombinant HBV vaccine, 5 clinical trials were conducted among healthy Koreans. In addition, a small-scale clinical trial was done in Vietnam to evaluate the immunogenicity and safety of Euvax-B. Several different parameters were compared in these studies: difference in age and sex distribution, seroconversion rate, geometric mean titers between the experimental vaccine group (Euvax-B) and control vaccine group (plasma-derived vaccine), as well as safety in the Euvax-B group.
When small differences in sex and age distribution were observed, they had no consequence on the ability to compare between-group immunogenicity. There was no difference in the immunogenicity between the two groups when the same vaccination schedule was compared, but the 0-, 1- and 6-month schedule was considered to be better than the 0-, 1- and 2-month schedule for long-term immunogenicity. The immunogenicity of the recombinant HBV vaccine was as good as the plasma-derived HBV vaccine, when considering the seroconversion rates and the antibody titer levels. There was no case observed of HBsAg seropositivity or episode of clinical hepatitis among study subjects during these studies. Adverse reactions observed in study groups after vaccination were mild and symptoms were temporary.
Overall, available data indicate that immunisation against hepatitis B using the yeast-derived recombinant hepatitis B vaccine produced by LG Chem, Ltd (Euvax-B) is efficacious for both the 2- and the 6-month schedules, making it possible to choose between 2- and 6-month schedule according to the vaccinee's convenience. The safety and immunogenicity of Euvax-B was documented in all age groups.