Project description DEENESFRITPL A DNA vaccine platform against SARS-CoV-2 Accumulating genetic evidence on the new SARS-CoV-2 virus shows that its envelope and receptor binding domain only share 75 % homology with other human coronaviruses. This indicates that existing immunotherapies and vaccine candidates against other coronaviruses will probably not work against SARS-CoV-2. To generate and select the most potent candidates that protect against SARS-CoV-2 infection, the EU-funded OPENCORONA project will use a DNA vaccine platform. The most promising leads will initially be validated in animal models of coronavirus infection and then tested in a phase I clinical trial for safety in healthy volunteers. Show the project objective Hide the project objective Objective 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. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health scienceshealth sciencesinfectious diseasesRNA virusescoronavirusesmedical and health sciencesbasic medicineimmunologyimmunotherapy Keywords 2019-nCoV SARS-CoV-2 therapy vaccine Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Topic(s) SC1-PHE-CORONAVIRUS-2020 - Advancing knowledge for the clinical and public health response to the 2019-nCoV epidemic Call for proposal H2020-SC1-PHE-CORONAVIRUS-2020 See other projects for this call Funding Scheme RIA - Research and Innovation action Coordinator KAROLINSKA INSTITUTET Net EU contribution € 423 067,89 Address Nobels Vag 5 17177 Stockholm Sweden See on map Region Östra Sverige Stockholm Stockholms län Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 423 067,89 Participants (6) Sort alphabetically Sort by Net EU contribution Expand all Collapse all JUSTUS-LIEBIG-UNIVERSITAET GIESSEN Germany Net EU contribution € 185 860,00 Address LUDWIGSTRASSE 23 35390 Giessen See on map Region Hessen Gießen Gießen, Landkreis Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 185 860,00 FOLKHALSOMYNDIGHETEN Sweden Net EU contribution € 391 072,11 Address NOBELS VAG 18 171 82 Solna See on map Region Östra Sverige Stockholm Stockholms län Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 391 072,11 IGEA SPA Italy Net EU contribution € 200 000,00 Address VIA PARMENIDE 10a 41012 Carpi Mo See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Nord-Est Emilia-Romagna Modena Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 200 000,00 NORTHX BIOLOGICS MATFORS AB Sweden Net EU contribution € 1 200 000,00 Address BOX 219 864 23 Matfors See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Norra Sverige Mellersta Norrland Västernorrlands län Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 1 200 000,00 ADLEGO BIOMEDICAL AB Sweden Net EU contribution € 200 000,00 Address BOX 42 751 03 Uppsala See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Östra Sverige Östra Mellansverige Uppsala län Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 200 000,00 REGION STOCKHOLM Sweden Net EU contribution € 400 000,00 Address HANTVERKARGATAN 45 104 22 Stockholm See on map Region Östra Sverige Stockholm Stockholms län Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 400 000,00