A prefusion SARS-CoV-2 spike RNA vaccine is highly immunogenic and prevents lung infection in non-human primates
Vogel, A.; Kanevsky, I.; Che, Y.; Swanson, K.; Muik, A.; Vormehr, M.; Kranz, L.; Walzer, K.; Hein, S.; Gueler, A.; Loschko, J.; Maddur, M.; Tompkins, K.; Cole, J.; Lui, B. G.; Ziegenhals, T.; Plaschke, A.; Eisel, D.; Dany, S.; Fesser, S.; Erbar, S.; Bates, f.; Schneider, D.; Jesionek, B.; Saenger, B.; Wallisch, A.-K.; Feuchter, Y.; Junginger, H.; Krumm, S.; Heinen, A.; Adams-Quack, P.; Schlereth, J.; Kroener, C.; Hall-Ursone, S.; Brasky, K.; Griffor, M. C.; Han, S.; Lees, J.; Mashalidis, E.; Sahasrabudhe, P.; Tan, C.; Pavliakova, D.; Singh, G.; Fontes-Garfias, C.; Pride, M.; Scully, I.; Ciolin
Show abstract
To contain the coronavirus disease 2019 (COVID-19) pandemic, a safe and effective vaccine against the new severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is urgently needed in quantities sufficient to immunise large populations. In this study, we report the design, preclinical development, immunogenicity and anti-viral protective effect in rhesus macaques of the BNT162b2 vaccine candidate. BNT162b2 contains an LNP-formulated nucleoside-modified mRNA that encodes the spike glycoprotein captured in its prefusion conformation. After expression of the BNT162b2 coding sequence in cells, approximately 20% of the spike molecules are in the one-RBD up, two-RBD down state. Immunisation of mice with a single dose of BNT162b2 induced dose level-dependent increases in pseudovirus neutralisation titers. Prime-boost vaccination of rhesus macaques elicited authentic SARS-CoV-2 neutralising geometric mean titers 10.2 to 18.0 times that of a SARS-CoV-2 convalescent human serum panel. BNT162b2 generated strong TH1 type CD4+ and IFN{gamma}+ CD8+ T-cell responses in mice and rhesus macaques. The BNT162b2 vaccine candidate fully protected the lungs of immunised rhesus macaques from infectious SARS-CoV-2 challenge. BNT162b2 is currently being evaluated in a global, pivotal Phase 2/3 trial (NCT04368728).
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