VII Simposio Internacional de Ciencias Farmacéuticas 2019 "VII SICF" -VII Simposio "Diseño, Obtención y Desarrollo de Fármacos"

VII Simposio Internacional de Ciencias Farmacéuticas 2019

VII SICF

SAFETY ASSESSMENT OF THE NASVAC, A FORMULATION OF ANTIGENS AS VIRUS-LIKE PARTICLES.

Resumen [ES]

Developing an effective vaccine need a development of a technological framework and compliant with established regulatory and safety requirements. A novel vaccine formulation was designed with mucosal/parenteral simultaneous administration (NASVAC) was obtained at the Center for Genetic Engineering and Biotechnology. The present work describes the preclinical safety strategy based on acute toxicity and repeated doses assays using F1 rabbits and Sprague Dawley rats. The results revealed NASVAC do not produce effects that may alter the normal weight gain of the species used. The clinical signs observed were considered independent from the treatments applied. In biochemistry, values of creatinine (in males) and phosphorus (in females) were higher in all groups treated with NASVAC; these values were also verified to be above the reference values given by the supplier. The determination of the organs relative weight of interest demonstrated the lack of incidence of the dose levels and the frequency of the administration of the formulation evaluated in this parameter. The histopathological evaluation showed that the repeated administration of the product or its components does not produce adverse or toxic effects in the animals evaluated. The irritation indexes in all groups treated with NASVAC was the same and lowers to the minimum category of the used scale. The results allowed us to conclude that NASVAC formulation does not cause toxic and irritating effects even at repeated parenteral/nasal administrations. The No Adverse Effects Level was 71 mg/kg in rats and 24 µg/kg in rabbits. NASVAC is safe for its application in humans.

Resumen [EN]

Developing an effective vaccine need a development of a technological framework and compliant with established regulatory and safety requirements. A novel vaccine formulation was designed with mucosal/parenteral simultaneous administration (NASVAC) was obtained at the Center for Genetic Engineering and Biotechnology. The present work describes the preclinical safety strategy based on acute toxicity and repeated doses assays using F1 rabbits and Sprague Dawley rats. The results revealed NASVAC do not produce effects that may alter the normal weight gain of the species used. The clinical signs observed were considered independent from the treatments applied. In biochemistry, values of creatinine (in males) and phosphorus (in females) were higher in all groups treated with NASVAC; these values were also verified to be above the reference values given by the supplier. The determination of the organs relative weight of interest demonstrated the lack of incidence of the dose levels and the frequency of the administration of the formulation evaluated in this parameter. The histopathological evaluation showed that the repeated administration of the product or its components does not produce adverse or toxic effects in the animals evaluated. The irritation indexes in all groups treated with NASVAC was the same and lowers to the minimum category of the used scale. The results allowed us to conclude that NASVAC formulation does not cause toxic and irritating effects even at repeated parenteral/nasal administrations. The No Adverse Effects Level was 71 mg/kg in rats and 24 µg/kg in rabbits. NASVAC is safe for its application in humans.

Sobre el ponente

Dania Bacardí Fernández

Dr. Dania Bacardí Fernández

CIGB Flag of Cuba
Información Práctica
Spanish / Español
No definido
30 minutos
No definido
Autores
Julio Ancizar Fragoso
Hainer Martínez Cabrera
Julio Aguilar Rubido.
Karelia Cosme Díaz
Dioslaida Urquiza Noa Juan Carlos Romero Chamizo
Jose Suárez Alba
Ana Valdés Esquijarosa
Leticia Martínez Ruíz
Dr. Dania Bacardí Fernández
Palabras clave
nasvac
safety assessment
virus-like particles