Determination of endotoxicity in bacterial vaccines.

Endotoxicity of bacterial vaccines was quantitated in mice by using actinomycin D as potentiating agent. The results were compared with those obtained by the mouse weight gain test. The lethality of Escherichia coli lipopolysaccharide was increased 2,140 times when 12.5 mug of actinomycin D was used. The mean lethal dose values of heated and unheated pertussis vaccines were similar in the actinomycin D enhancement assay, but the unheated vaccine was significantly more toxic in the mouse weight gain test. Acetone-inactivated typhoid vaccine was slightly less toxic than the heat-phenol-inactivated vaccine in both the actinomycin D enhancement assay and mouse weight gain test. Endotoxicity of experimental vaccines prepared by extraction of Pseudomonas aeruginosa strains was high as compared with E. coli lipopolysaccharide. The BALB/c mice were about four times more susceptible than the random bred NIH strain mice. The results indicate that the actinomycin D enhancement assay had the advantages of being more sensitive and probably more specific.