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Recombinant Fc-fusion vaccine of RBD induced protection against SARS-CoV-2 in non-human primate and mice

Sun, Y.; Han, G.; Wei, W.; Hu, Z.; Sun, S.; He, L.; Zhao, Z.; Gu, H.; Wang, T.; Yang, X.; Chen, S.; Deng, Y.; Li, J.; Zhao, J.; Li, L.; Li, X.; He, P.; Li, G.; Li, H.; Gao, C.; Lang, X.; Geng, S.; Wang, X.; Fei, G.; Li, Y.; Gao, Y.; Fang, X.; Zhao, Y.

2020-11-30 immunology
10.1101/2020.11.29.402339 bioRxiv
Show abstract

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) continues to infect people globally. The increased COVID-19 cases and no licensed vaccines highlight the need to develop safe and effective vaccines against SARS-CoV-2 infection. Multiple vaccines candidates are under pre-clinical or clinical trails with different strengths and weaknesses. Here we developed a pilot scale production of a recombinant subunit vaccine (RBD-Fc Vacc) with the Receptor Binding Domain of SARS-CoV-2 S protein fused with the Fc domain of human IgG1. RBD-Fc Vacc induced SARS-CoV-2 specific neutralizing antibodies in non-human primates and human ACE2 transgenic mice. The antibodies induced in macaca fascicularis neutralized three divergent SARS-CoV2 strains, suggesting a broader neutralizing ability. Three times immunizations protected Macaca fascicularis (20ug or 40ug per dose) and mice (10ug or 20ug per dose) from SARS-CoV-2 infection respectively. These data support clinical development of SARS-CoV-2 vaccines for humans. RBD-Fc Vacc is currently being assessed in randomized controlled phase 1/II human clinical trails. SummaryThis study confirms protective efficacy of a SARS-CoV-2 RBD-Fc subunit vaccine.

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