PT  - JOURNAL ARTICLE
AU  - A.V. Vakhrusheva
AU  - A.V. Kudriavtsev
AU  - N.A. Kryuchkov
AU  - R.V. Deev
AU  - M.E. Frolova
AU  - K.A. Blagodatskikh
AU  - M. Djonovic
AU  - A.A. Nedorubov
AU  - E. Odintsova
AU  - A.V. Ivanov
AU  - E.A. Romanovskaya-Romanko
AU  - M.A. Stukova
AU  - A.A. Isaev
AU  - I.V. Krasilnikov
TI  - SARS-CoV-2 Subunit Virus-Like Vaccine Demonstrates High Safety Profile and Protective Efficacy: Preclinical Study
AID  - 10.1101/2022.05.18.492452
DP  - 2022 Jan 01
TA  - bioRxiv
PG  - 2022.05.18.492452
4099  - http://biorxiv.org/content/early/2022/05/18/2022.05.18.492452.short
4100  - http://biorxiv.org/content/early/2022/05/18/2022.05.18.492452.full
AB  - Public health threat coming from a rapidly developing COVID-19 pandemic calls for developing safe and effective vaccines with innovative designs. This paper presents preclinical trial results of “Betuvax-CoV-2”, a vaccine developed as a subunit vaccine containing a recombinant RBD-Fc fusion protein and betulin-based spherical virus-like nanoparticles as an adjuvant (“Betuspheres”). The aim of the study was to demonstrate vaccine safety in mice, rats, and Chinchilla rabbits through acute, subchronic, and reproductive toxicity studies. Along with safety, the vaccine demonstrated protective efficacy through SARS-CoV-2-neutralizing antibody production in mice, rats, hamsters, rabbits, and primates (rhesus macaque), and lung damage and infection protection in hamsters and rhesus macaque model. Eventually, “Betuvax-CoV-2” was proved to confer superior efficacy and protection against the SARS-CoV-2 in preclinical studies. Based on the above results, the vaccine was enabled to enter clinical trials that are currently underway.Competing Interest StatementA.A.I., I.V.K., M.E.F., A.V.K., A.V.V., A.V.I. have author's rights to the patent RU2749193 "Method for preparation of betulin for use as adjuvant in vaccine against SARS-CoV-2 coronavirus" (registered by Betuvax). N.A.K., R.V.D., A.A.N., E.O., A.V.I., E.A.R-R., M.A.S., K.A.B., M.D. had received financial support from company Betuvax for provided scientific work. A.A.I., I.V.K., M.E.F., A.V.K., A.V.V. are shareholders of Betuvax. A.V.V. is an employee of Betuvax.