Abstract

INFANTE, Juan F et al. Single dose toxicity and local tolerance evaluation of the vax-SPIRAL® vaccine in Sprague Dawley rats. Vaccimonitor [online]. 2004, vol.13, n.2, pp. 11-16. ISSN 1025-0298.

The pre-clinical toxicity tests in single dose and repeated doses give valuable information on the safety of the product, since they include the pathological and histopathological study of important organs, as well as the evaluation of the administration route and the dosage regime. At present, Cuba is Developing a polyvalent vaccine (vax-SPIRAL®) from chemically inactivated cells, with an aluminium hydroxide adjuvant. This vaccine has advantages vis a vis other vaccines, as for example, the vaccine from the former Soviet Union. The vaccination schedule for humans consists in two doses of 0.5 mL, separated by an optimal interval of six weeks. The objective of this toxicity study in Sprague Dawley rats was to determine the potential toxicity, lethality, susceptible organs and other adverse events, as well as toxicity in the inoculation site after administering one dose of the vaccine under study. The results indicated that, under the conditions of the study and according to the established criteria for evaluating the data obtained, the antileptospirosic trivalent vaccine dose did not produce toxic effects in the animal model used. The only alterations found were granuloma formations at the inoculation site. These formations have been reported as belonging to the deposit adjuvant (aluminum hydroxide), also used in the other parenteral vaccines.

Keywords : Leptospirosis; Rat; Single Dose; Toxicology; Vaccine,; vax-SPIRAL.

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