Collaborative study for the validation of serological methods for potency testing of tetanus toxoid vaccines for human use.
The assayed potency of an adsorbed tetanus toxoid C(2), relative to the international standard for tetanus toxoid (adsorbed), varied significantly with the use of different strains of mice. The unitage was highest with NIH mice, and it was not significantly different from that with CFW mice. With CDF(1) and BALB/c mice, however, the assayed potency was significantly lower than with NIH mice. C3H mice failed to respond to the dose range of the toxoids employed with the other four strains. The significance of the influence of the mouse strain on the designation of a prescribed unit requirement for tetanus toxoid, adsorbed, relative to human efficacy is discussed.