Abstract

A method has been developed for quantitative determination of the early appearing mouse paw swelling activity of pertussis vaccine. Mice were inoculated with the vaccine into the left hind paws. The difference in the thicknesses between the inoculated and the uninoculated paws was taken as the swelling response in 16 hr after inoculation. It was transformed into logarithm as a response metameter. A linear log dose-log response regression line was obtained over a relatively wide range of doses of the vaccine. No deviation from parallelism was significant among the regression lines of different vaccines tested. The swelling activities relative to that of a reference vaccine of diphtheria-pertussis-tetanus combined (DPT) vaccines recently produced in Japan were determined. The relative activities ranged from 0.6 to 2.5, being twice the mean width of the 95% confidence interval of the relative activity. Further experiments showed that the activity significantly correlated with endotoxin and histamine-sensitizing factor (HSF) but not with lymphocytosis-promoting factor (LPF). In addition, the multiple regression analysis of such relationship suggested that the swelling activity is accounted for by the combined action of endotoxin and HSF. A model experiment with a mixture of the two toxins supported this conclusion.

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