Toxicología de VA-DIFTET por aplicación a dosis única en ratones

A highly purified vaccine against Tetanus and Diphtheria, suitable to be applied in children and pregnant women is of great importance. Toxicological evaluations should be increasingly more comprehensive as nowadays specific and non-specific tests of safety are not considered enough. After standard toxicological tests had been carried out to VA-DIFTET (A highly purified vaccine against tetanus and diphtheria), a sounder toxicological evaluation was developed to the vaccine and their components. Male and female OF-1 mice received a single application of VA-DIFTET or each component of the vaccine by intramuscular or intraperitoneal route. Animals were observed during 14 days. Body weights increases, and daily average water and food intakes were determined. At the end of the experiment mice were sacrificed and anatomopathological evaluations were carried out. Some statistical differences were found in the variables evaluated, but not of biological importance. No symptoms of toxicity were observed. Lesions were incidental or the typical granuloma of adjuvants like Aluminum hydroxide. Results evidenced the safety of VA-DIFTET and its components and allowed to pursue similar researches in guinea pigs.