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ISSN 1027-2852 (Electronic)
ISSN 0864-4551 (Print)

2018, Number 3

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Biotecnol Apl 2018; 35 (3)

Single dose toxicity non-clinical evaluation of the anti-meningococcal vaccine VA-MENGOC-BC® in Sprague Dawley rats to extend its shelf-life to 36 months

Oliva-Hernández R, Fariñas-Medina M, Hernández-Salazar T, Infante-Bourzac JF, Núñez-Martínez D, Quintero-Pérez A, Sierra-González G

Language: English
References: 26
Page: 3212-3215
PDF size: 518.06 Kb.


ABSTRACT

VA-MENGOC-BC® is a safe and effective vaccine for the prevention of meningococcal meningitis against serogroups B and C. It has demonstrated good stability over time without losing its quality required as a product for up to two years. But stability studies have shown that the useful shelf-life of this product could be extended to three years. Therefore, this work was aimed to evaluate the possible toxic potential of VA-MENGOC-BC®, in a single dose study conducted in Sprague Dawley rats. Batches of VA-MENGOC-BC® kept at a controlled temperature of 4 to 8 ° C for 24 and 36 months were administered to animals. The experimental design included the daily observation of animals, the assessment of water and food consumption, thermometry, muscle volume and body weight. Animals were necropsied for anatomopathological studies, seeking for evidences of possible adverse effects after immunization. No symptoms of toxicity or deaths were observed during the study. No differences of toxicological interest were found among the experimental groups in terms of body weight, water and food consumption. No lesions of diagnostic value were observed in anatomopathologic analyses. At the site of inoculation, granulomatous processes as mediated by macrophage activation were found, which are characteristic of vaccines adjuvanted with aluminum hydroxide. These results indicated that the shelf-life of the VA-MENGOC-BC® vaccine can be extended from 24 to 36 months, due to the lack of local adverse or systemic toxic effects in the assayed animal model.


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