The interpretation of hepatitis B virus vaccine immunogenicity tests on mice

The "Proposed requirements for Hepatitis B vaccine" published by the W.H.O. does not contain distinct immunogenicity tests for the quality control of the HBV vaccine. In this study we focus on a number of alternatives of conducting immunogenicity tests on mice and on questions as: should the mice necessarily be of H-2q haplotype? Is it necessary to screen the mice for the presence of anti-HBs prior to injection? How should the radioimmunological anti-HBs determination be interpreted? What is the cut-off value (2.1 X N or 10 m IU/ml) that will be used in this determination. There can be concluded that ED50 rates depends upon the used alternatives. The results of the immunogenicity tests on mice are compared with in vitro activity assays of the vaccine.