Abstract

OLIVA-HERNANDEZ, Reynaldo et al. Local tolerance study of the VA-MENGOC-BC^® antimeningococcal vaccine in Sprague Dawley rats. Evaluation at 24 and 36 months of shelf. Vaccimonitor [online]. 2019, vol.28, n.1, pp. 9-18. ISSN 1025-0298.

Meningococcal meningitis continues to be a health problem in different countries and different vaccines have been obtained for the prevention of this disease. VA-MENGOC-BC® vaccine has been effective and safe in the prevention of meningococcal meningitis against serogroups B and C. This has shown good stability over time without changing its quality as a product; it was stored on a shelf for 24 and 36 months at temperatures of 4 to 8 °C. Their possible toxicological potential was evaluated through a local tolerance study in Sprague Dawley rats. Immunized animals were observed daily to evaluate local and systemic toxicity symptoms. Body weight, water and feed intake, thermometry, musculometry were performed and dermal irritability by the Draize method. Anatomopathological studies to observe possible adverse effects were made. No symptoms of toxicity or deaths were observed. No differences were found between the experimental groups in terms of body weight, water and food consumption, no fever or local irritability was evident. Anatomopathologically no lesions of diagnostic value were observed, at the site of inoculation, granulomatous processes of macrophagic type characteristic in vaccines containing aluminum hydroxide were observed. These results allowed us to conclude that the VA-MENGOC-BC® vaccine that remained on the shelf for 24 and 36 months did not show any local or systemic effects in rats.

Keywords : VA-MENGOC-BC^®; local tolerance; thermometry; musculometry; dermal irritability; Sprague Dawley.

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