Single Dose Toxicity Study of the ACW135 Antimeningococcal Vaccine in Sprague Dawley Rats

The combined vaccine of purified polysaccharides of the A, C and W135 meningococcal serogroups, are of new obtaining and production among Finlay Institute, Cuba and Bio-Manguinhos/FIOCRUZ Institute, Brazil. To study the toxicological potential of this vaccine against meningococcal of these serogrupos, we were carried out a study of single dose toxicity via intramuscular in Sprague Dawley rats. Was administered 0,2 mL volume of the vaccine. Once treaties, the animals were observed daily in search of local and systemic symptoms of toxicity during 14 days. They were carried out, mensurations of water and food consumption, and the corporal weight. We performed the euthanasia to the animals fulfilling the established and subjected ethical demands to autopsy carrying out anatomopathologic studies to observe possible adverse effects after the immunization with the vaccine. Were not observed toxicity symptoms neither deaths during the study in the animals. There were not differences of toxicological interest among the experimental groups as for the corporal weight and the water and foods consumption. In the anatomopathological study lesions of value diagnosis were not observed. These results allowed to conclude that the vacunal candidate doesn't evidence to take place neither clinical symptoms, deaths, local adverse effects, neither systemic of toxicological type in the used animal model, when being applied in single dose.