RT Journal Article SR Electronic T1 mRNA vaccine CVnCoV protects non-human primates from SARS-CoV-2 challenge infection JF bioRxiv FD Cold Spring Harbor Laboratory SP 2020.12.23.424138 DO 10.1101/2020.12.23.424138 A1 Rauch, Susanne A1 Gooch, Karen A1 Hall, Yper A1 Salguero, Francisco J. A1 Dennis, Mike J. A1 Gleeson, Fergus V. A1 Harris, Debbie A1 Ho, Catherine A1 Humphries, Holly E. A1 Longet, Stephanie A1 Ngabo, Didier A1 Paterson, Jemma A1 Rayner, Emma L. A1 Ryan, Kathryn A. A1 Sharpe, Sally A1 Watson, Robert J. A1 Mueller, Stefan O. A1 Petsch, Benjamin A1 Carroll, Miles W. YR 2020 UL http://biorxiv.org/content/early/2020/12/23/2020.12.23.424138.abstract AB The ongoing severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic necessitates the fast development of vaccines to meet a worldwide need. mRNA-based vaccines are the most promising technology for rapid and safe SARS-CoV-2 vaccine development and production. We have designed CVnCoV, a lipid-nanoparticle (LNP) encapsulated, sequence optimised mRNA-based SARS-CoV-2 vaccine that encodes for full length, pre-fusion stabilised Spike protein. Unlike other mRNA-based approaches, CVnCoV exclusively consists of non-chemically modified nucleotides and can be applied at comparatively low doses. Here we demonstrate that CVnCoV induces robust humoral and cellular responses in non-human primates (NHPs). Animals vaccinated with 8 μg of CVnCoV were protected from challenge infection with SARS-CoV-2. Comprehensive analyses of pathological changes in challenged animals via lung histopathology and Computed Tomography (CT) scans gave no indication of enhanced disease upon CVnCoV vaccination. These results demonstrate safety, immunogenicity, and protective efficacy of CVnCoV in NHPs that extend our previously published preclinical data and provide strong support for further clinical testing in ongoing phase 2b/3 efficacy studies.Competing Interest StatementS.R., B.P., and S.O.M. are employees of CureVac AG, Tuebingen Germany, a publically listed company developing RNA-based vaccines and immunotherapeutics. All authors may hold shares or stock options in the company. S.R. and B.P. inventors on several patents on mRNA vaccination and use thereof.