Prueba toxicológica en ratones de una sola dosis inicial y segura de la vacuna cubana antileptospirósica Vax-SPIRAL

Toxicological Evaluation in Mice of an Initial Safe Single Dose for Vax-SPIRAL, a Cuban Vaccine against Leptospirosis. Toxicological tests on vaccines are increasingly exigent, and specific and non-specific safety tests are not considered sufficient any longer. Vax-SPIRAL is an inactivated whole-cell leptospiral vaccine adsorbed to aluminum hydroxide. The toxicity test by single dose in at least one animal species is included among the pre- clinical tests demanded to satisfactorily demonstrate the safety of vaccines against Leptospirosis. The aim of this work was to fulfill this requisite. A single dose of Vax-SPIRAL or of each component of the vaccine were inoculated to 200 OF1 mice (100 of each sex) by intramuscular or intraperitoneal routes. Mice were observed for 14 days, and body weight increases, water consumption and food intake were measured. Two weeks after inoculation all mice were sacrificed for anatomopathological examination. No clinical symptoms of toxicity were observed and differences between treatments were not biologically or statistically significant. Granulomatous processes typical of depot adjuvants, as well as incidental lesions, were found during macro- and microscopic examinations. The results demonstrated the low toxicity of a single dose of Vax-SPIRAL in mice.