Resumen

NUNEZ, Juan F et al. Study of toxicity by single dose and local tolerance of a meningococcal vaccine type B in Sprague Dawley rats. Vaccimonitor [online]. 2006, vol.15, n.2, pp. 18-21. ISSN 1025-0298.

The meningococcal B vaccine contains purified outer membrane vesicles of serogroup B meningococcus of strain (Cu- 385 - 83) B: 4:P1.19, 15. The vaccination scheme proposed for humans consists in three doses of 0.5 mL, separated by an optimal interval of eight weeks. The objective of this toxicity study in Sprague Dawley (SD) rats was to determine potential toxicity, lethality, sensitive organs and systems and other adverse events as well as toxicity at the inoculation site after administration of one dose of the vaccine under study. Results indicated that,under the study conditions and according to the criteria established to evaluate results, the meningococcal B vaccine does not produce toxic effects in the animal model used. Only granulomatous formations at the level of the inoculation site were observed. These formations have been reported tocharacteristic of deposit adjuvants like aluminium hydroxide used in other parenteral vaccines. It is concluded that the meningococcal B vaccine resulted to be satisfactory in the tests of toxicity by single dose and local tolerance carried out in rats.

Palabras clave : Toxicity,; single dose; local Tolerance; meningococcal B vaccine; rats.

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