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Rapid therapy development through Open nCoronavirus Vaccine Platform

Description du projet

Une plateforme de vaccin à ADN contre le SRAS-CoV-2

L’accumulation de preuves génétiques sur le nouveau virus SRAS-CoV-2 montre que son enveloppe et son domaine de liaison aux récepteurs ne partagent que 75 % d’homologie avec d’autres coronavirus humains. Cela indique que les immunothérapies et vaccins candidats existants contre d’autres coronavirus ne fonctionneront probablement pas contre le SRAS-CoV-2. Pour générer et sélectionner les candidats les plus puissants qui protègent contre l’infection par le SRAS-CoV-2, le projet OPENCORONA, financé par l’UE, utilisera une plateforme de vaccin à ADN. Les pistes les plus prometteuses seront initialement validées dans des modèles animaux d’infection à coronavirus, puis testées dans un essai clinique de phase I pour la sécurité chez des volontaires sains.

Objectif

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.

Coordinateur

KAROLINSKA INSTITUTET
Contribution nette de l'UE
€ 423 067,89
Adresse
Nobels Vag 5
17177 Stockholm
Suède

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Région
Östra Sverige Stockholm Stockholms län
Type d’activité
Higher or Secondary Education Establishments
Liens
Coût total
€ 423 067,89

Participants (6)