PT  - JOURNAL ARTICLE
AU  - Rauch, Susanne
AU  - Gooch, Karen
AU  - Hall, Yper
AU  - Salguero, Francisco J.
AU  - Dennis, Mike J.
AU  - Gleeson, Fergus V.
AU  - Harris, Debbie
AU  - Ho, Catherine
AU  - Humphries, Holly E.
AU  - Longet, Stephanie
AU  - Ngabo, Didier
AU  - Paterson, Jemma
AU  - Rayner, Emma L.
AU  - Ryan, Kathryn A.
AU  - Sharpe, Sally
AU  - Watson, Robert J.
AU  - Mueller, Stefan O.
AU  - Petsch, Benjamin
AU  - Carroll, Miles W.
TI  - mRNA vaccine CVnCoV protects non-human primates from SARS-CoV-2 challenge infection
AID  - 10.1101/2020.12.23.424138
DP  - 2020 Jan 01
TA  - bioRxiv
PG  - 2020.12.23.424138
4099  - http://biorxiv.org/content/early/2020/12/23/2020.12.23.424138.short
4100  - http://biorxiv.org/content/early/2020/12/23/2020.12.23.424138.full
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.