RESUMEN
Licensed as well as candidate cholera vaccines available at the present requires the dose preparation (included buffer) at the moment of application. The aim of this work was to evaluate the presentation in oral tablets of an inactivated cholera vaccine to avoid that inconveniences during application. We have therefore compared inactivated cultures of Vibrio cholerae with tablets formulation vaccine. We obtained that antigenic activity (ELISA) and immunogenicity in animal model (ELISA and vibriocidal tests) of V. cholerae inactivated cell remained unaltered in the final tablet formulation. The results suggest that the oral tablet formulation could be a useful pharmaceutical form in order to produce a new and affordable cholera vaccine.
Asunto(s)
Vacunas contra el Cólera/administración & dosificación , Cólera/prevención & control , Administración Oral , Animales , Anticuerpos Antibacterianos/sangre , Vacunas contra el Cólera/inmunología , Recuento de Colonia Microbiana , Ensayo de Inmunoadsorción Enzimática , Modelos Animales , Conejos , Comprimidos , Vacunas de Productos Inactivados/administración & dosificación , Vacunas de Productos Inactivados/inmunología , Vibrio cholerae/inmunologíaRESUMEN
Genetically modified Vibrio cholerae strain 638 (biotype El Tor, serotype Ogawa) has previously been shown to be immunogenic in animal models and in human trials. Our objective in the work reported herein was to describe the process development methods for the production of the 638 attenuated cholera vaccine. Cell seed bank, culture of biomass, lyophilization and final formulation were processes were developed. The results show kinetics of culture that fulfils a logistical model. The microbiological properties, colonizing capability, immunogenicity and non-toxigenicity of the final product were indistinguishable from the properties of the working seed lot. We conclude that the non-reactogenic, immunogenic and protective strain 638 is robust and can withstand the fermentation processes required for large-scale production of a vaccine.
Asunto(s)
Vacunas contra el Cólera , Tecnología Farmacéutica , Vibrio cholerae/inmunología , Animales , Cólera/prevención & control , Toxina del Cólera/análisis , Vacunas contra el Cólera/efectos adversos , Vacunas contra el Cólera/inmunología , Industria Farmacéutica , Fermentación , Humanos , Ratones , Ratones Endogámicos BALB C , Modelos Animales , Vacunas Atenuadas/efectos adversos , Vacunas Atenuadas/inmunología , Vibrio cholerae/genética , Vibrio cholerae/patogenicidad , Vibrio cholerae/fisiologíaRESUMEN
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