Descripción del proyecto
Una nueva vacuna contra el virus del SARS-CoV-2
La carrera para desarrollar una vacuna contra el coronavirus del síndrome respiratorio agudo grave de tipo 2 (SARS-CoV-2, por sus siglas en inglés) está en marcha. El proyecto financiado con fondos europeos Prevent-nCoV utilizará una tecnología patentada para diseñar una nueva vacuna escalable con eficacia probada en un modelo animal. La tecnología combina de manera excepcional partículas similares a virus y el antígeno de elección producido por cualquier sistema de expresión. Los dos componentes se mezclan en condiciones naturales, lo que favorece la exposición con una alta densidad del antígeno en la superficie de las partículas similares a virus. Las vacunas candidatas se evaluarán primero para determinar su capacidad de neutralización del virus «in vitro» y en modelos de infección preclínica antes de proceder con un ensayo clínico de fase I / IIa.
Objetivo
Our aim is to perform pre-clinical and clinical evaluation of a potential Wuhan Coronavirus vaccine candidate. The vaccine will be based on Virus-Like Particle (VLP) display of the SARS-CoV-2 Spike protein antigen. AdaptVac's VLP display technology has been shown to significantly improve vaccine immunogenicity, longevity and efficacy, for a wide range of viral and parasite diseases in pre-clinical studies (including flu and malaria). A unique feature of the technology is its two-component approach. The VLP is generic to all vaccines, and produced at >1g/L yields using E. coli. The disease antigen is produced in any expression system, allowing the most challenging antigens to be successfully produced. The VLP and antigen is then simply mixed, and a spontaneous, irreversible, conjugation
occurs under physiological conditions. This results in site-specific, directional, and high-density display of the antigen on the VLP surface. The antigen will be produced using ExpreS2ion's Drosophila S2 insect cells based on the trimetric spike antigen. Furthermore, E. coli and baculovirus will be tested for Spike protein variants. The vaccine candidates will be tested pre-clinically using in vitro viral neutralization assays and possibly animal challenge
models as they become available at LUMC. ExpreS2ion will develop the production processes and transfer these for GMP manufacture of the VLP and vaccine antigen, outsourced, to AGC Biologics. Finally, a phase I/IIa study will be performed at Radboud University Medical Center in the Netherlands. A surrogate marker of protection will be established by showing protection in animal models using passive transfer of participant sera, or by in vitro SARS-CoV-2 viral neutralization. This project is focused on delivering a scalable vaccine, ready for testing in the field, which has been shown to be safe in humans and effective in in vitro or animal models.
Ámbito científico
Palabras clave
Programa(s)
Convocatoria de propuestas
H2020-SC1-PHE-CORONAVIRUS-2020
Consulte otros proyectos de esta convocatoriaRégimen de financiación
RIA - Research and Innovation actionCoordinador
1165 Kobenhavn
Dinamarca