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Immunogenicity of hepatitis B vaccine in guinea-pigs, mice and man
Authors:M C Mazert  L Rabier  M Girard  A Goudeau
Abstract:The immunogenicity of the hepatitis B vaccine Hevac B Pasteur was assayed in guinea-pigs. The reproducibility of the test was determined by comparing the ImD50 of two samples of vaccine in 12 and eight groups of 40 animals each. The variation coefficient between groups was approximately 30%, similar to that found for other vaccines assayed in biological tests in vivo. The sensitivity of the test was determined by comparing the dose response curves in mice, guinea-pigs and humans. The results showed that one ImD50 in man (after one injection) was approximately equivalent to 3 ImD50 in guinea pigs and to 100 ImD50 in Balb/C mice. Stability of Hevac B at 37 degrees C was assayed by determining in guinea-pigs the ImD50 of a series of samples of vaccine that had been incubated at 37 degrees C for varying amounts of time. The immunogenicity of the vaccine was found to decay with a half-life of ten to 15 days at 37 degrees C.
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