Descripción del proyecto
Una vacuna de ADN recombinante contra el SARS-CoV-2
Numerosos indicios genéticos sobre el coronavirus del síndrome respiratorio agudo grave de tipo 2 (SARS-CoV-2, por sus siglas en inglés) revelan que su envoltura y dominio de unión a ligando solo comparten un 75 % de homología con otros coronavirus humanos. Esto pone de manifiesto que las inmunoterapias existentes y las vacunas candidatas contra otros coronavirus probablemente no sean eficaces contra el SARS-CoV-2. Para generar y seleccionar los candidatos más eficaces para proteger contra la infección por el SARS-CoV-2, el proyecto financiado con fondos europeos OPENCORONO empleará una vacuna de ADN recombinante. Las vacunas prototipo más prometedoras se validarán primero en modelos animales de infección por coronavirus y, seguidamente, se evaluarán mediante un ensayo clínico de fase I en voluntarios sanos para determinar su seguridad.
Objetivo
The OPENCORONA consortia will test a therapy that protects against 2019-nCoV infection and/or disease in a phase I clinical trial in 24 months. The spread of the 2019-nCoV (or SARS-CoV-2) between the Jan 21 and Feb 11 has expanded alarmingly. There are >43000 confirmed cases of which >1000 has died. Around 7000 have a severe disease. The infection still mainly affect mainland China, although an increasing number of cases are seen outside China. The major question is what will happen when China halts its massive isolation campaign. No approved human coronavirus immunotherapy or vaccine exists. Thus, speed in therapy and vaccine development is critical. Genetic analysis shows that the 2019-nCoV envelope and receptor binding domain only has a 75% homology with other human coronaviruses. Thus, existing immunotherapies and vaccine candidates against other coronaviruses, such as SARS, will not be useful against 2019-nCoV. We will use the DNA vaccine platform as this is currently the most rapid and robust vaccine platform today. We will generate chimeric 2019-nCoV genes (Figure 1) and select the most potent DNA vaccine/immunotherapy candidate delivered by in vivo electroporation that protects against 2019-nCoV infection and/or disease in animal models and take this to phase I clinical testing. The partners in the consortium have done this before and all know-how for reliable development is present. KI and FoHM will develop vaccine candidates and infectious models, JLU will test candidates for over-activation of innate immunity, IGEA will provide a CE marked device for in vivo electroporation in humans. Cobra will produce plasmid according to GMP, Adlego will perform toxicological testing according to GLP, and Karolinska will write the (Investigator’s brochure) and IMPD (Investigational Medicinal Products Dossier), file with ethics comitty and EMA, and perform a phase I clinical trial of the immunotherapy/vaccine in healthy volunteers. All these tasks are within the expertise that the partners do every day. Thus, this is truly realistic.
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
17177 Stockholm
Suecia