Abstract

OLIVA-HERNANDEZ, Reynaldo et al. Immunogenicity and acute toxicity assay of the vaccine candidate against cholera vax-COLER^®. Vaccimonitor [online]. 2020, vol.29, n.1, pp. 22-30.  Epub Apr 01, 2020. ISSN 1025-0298.

Different strategies have been carried out for the control and prevention of human cholera. Vaccination is one of the most effective strategies. Preclinical evaluation of vaccines needs to prove their safety; whereby toxicological studies are decisive. They are mandatory and highly regulated. This study was aimed to demonstrate the relevance of Sprague Dawley rats as a biomodel, through the immunological response to vax-COLER® cholera vaccine, using the technique of determination of vibriocidal antibodies. In addition, local and systemic toxicological effects were evaluated after administration of a dose of vax-COLER®; through the evaluation of symptoms, water and food consumption, body weight and anatomopathological studies. The vax-COLER® vaccine was immunogenic and showed no symptoms or deaths. No changes in body weight were detected, and food and water consumption were similar among all groups. The anatomopathological studies showed histological changes in the mesenteric lymph nodes and Peyer's patches of the vaccinated animals, with hyperplasia of the subcapsular secondary follicles, finding that differed significantly from the rest of the groups. It is concluded that vax-COLER® vaccine is immunogenic in Sprague-Dawley rats, demonstrating the relevance of the biomodel for the evaluation of preclinical safety, as well as that the application of a single dose did not produce acute general or local toxic effects.

Keywords : vaccine immunogenicity; acute toxicity tests; cholera vaccines; Vibrio cholerae; Sprague-Dawley rats.

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