Descrizione del progetto
Una piattaforma di vaccini a base di DNA contro la SARS-CoV-2
L’accumulo di evidenza genetica sul nuovo virus SARS-CoV-2 mostra che il suo inviluppo e il suo dominio di legame con il recettore condividono solo il 75 % di omologia con altri coronavirus umani. Ciò indica che le immunoterapie esistenti e i vaccini candidati contro altri coronavirus probabilmente non funzioneranno contro la SARS-CoV-2. Per generare e selezionare i candidati più potenti in grado di proteggere dall’infezione da SARS-CoV-2, il progetto OPENCORONA, finanziato dall’UE, utilizzerà una piattaforma di vaccini a base di DNA. I composti guida più promettenti saranno inizialmente convalidati in modelli animali di infezione da coronavirus e successivamente testati in una sperimentazione clinica di fase I per la sicurezza in volontari sani.
Obiettivo
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.
Campo scientifico
Parole chiave
Programma(i)
Argomento(i)
Meccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
17177 Stockholm
Svezia