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ESTUDIAN LA EFICACIA DE NUEVAS VACUNAS ANTIPOLIOVIRUS

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El modelo de inmunización y provocación en ratones transgénicos puede ser útil para determinar la inmunogenicidad y la protección conferidas por las nuevas vacunas con virus inactivados cuando el estudio en seres humanos no es posible.
ivanov9.jpg Autor:
Alexander Ivanov
Columnista Experto de SIIC

Institución:
Center for Biologics Evaluation and Research, US FDA

Artículos publicados por Alexander Ivanov
Coautores
Eugenia Dragunsky* Konstantin Chumakov** 
MD, PhD, Center for Biologics Evaluation and Research, US FDA, Rockville, EE.UU.*
PhD, ScD, Center for Biologics Evaluation and Research, US FDA, Rockville, EE.UU.**
Recepción del artículo
13 de Julio, 2006 		Aprobación
25 de Julio, 2006
Primera edición
21 de Diciembre, 2006 		Segunda edición, ampliada y corregida
7 de Junio, 2021

ESTUDIAN LA EFICACIA DE NUEVAS VACUNAS ANTIPOLIOVIRUS

Resumen
En esta revisión se analizan los abordajes metodológicos para valorar las propiedades protectoras de las nuevas vacunas con poliovirus inactivado (VPI) mediante el uso de ratones transgénicos susceptibles a poliovirus. Las vacunas incluyen una nueva generación de VPI elaborada a partir de cepas Sabin atenuadas (VPIs) así como una combinación de productos que consisten en otros antígenos protectores. Los autores describen sus propios resultados y los datos publicados por otros grupos con la finalidad de brindar una perspectiva completa de esta valoración. La prueba en ratones transgénicos se basa en la inmunización y la provocación (parte funcional de la prueba) e incluye determinación serológica. La comparación de la VPI convencional (VPIc) y de la VPIs de tipo I mostró que la VPIs tipo I tiene una excelente antigenicidad e induce un amplio efecto protector en ratones transgénicos. Se encontró que la VPIs tipo 2 inducía niveles más bajos de anticuerpos neutralizantes y menos protección que la VPIc tipo 2 en la prueba de provocación con el poliovirus salvaje. Los autores concluyen que la prueba en ratones transgénicos para determinar la inmunogenicidad y el efecto protector de la nueva VPIs es un método sustituto eficaz en situaciones en las cuales los trabajos de eficacia clínica en seres humanos son imposibles.

Palabras clave
vacuna contra poliovirus, modelo animal, protección, pruebas serológicas


Artículo completo
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METHODS IN ASSESSMENT OF EFFICACY OF INACTIVATED POLIOVIRUS VACCINES USING TRANSGENIC MICE SUSCEPTIBLE TO POLIOVIRUS

Abstract
This review concerns methodological approaches to assessment of protective properties of new inactivated poliovirus vaccines (IPV) using transgenic mice susceptible to poliovirus. Vaccines include a new generation of IPV that is made from attenuated Sabin strains (sIPV), as well as combination products that include other protective antigens. Authors describe their own results and data published by others in order to present comprehensive picture of this assessment. The transgenic mouse test is based on immunization-challenge (functional part of the test) and includes serological assessment. Comparison of conventional IPV (cIPV) and sIPV of type 1 showed that type 1 sIPV possesses excellent immunogenicity and protectivity in Tg-mice. It was found that sIPV of type 2 induced lower levels of neutralizing antibodies and was less protective than type 2 cIPV against challenge with wild-type poliovirus. Authors conclude that transgenic mouse test for evaluation of immunogenicity and protectivity of new IPVs is an effective surrogate method in situation when clinical efficacy trials in people are impossible.

Key words
poliovirus vaccine, animal model, protectivity, serological tests


Full text
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Especialidades
Principal: Inmunología
Relacionadas: Bioética, Bioquímica, Infectología, Medicina Interna, Neurología, Pediatría



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Enviar correspondencia a:
Alexander Ivanov, Center for Biologics Evaluation and Research, US FDA, MD 20852, 1401 Rockville Pike, Rockville, EE.UU.
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