RT Journal Article
SR Electronic
T1 SARS-CoV-2 Subunit Virus-Like Vaccine Demonstrates High Safety Profile and Protective Efficacy: Preclinical Study
JF bioRxiv
FD Cold Spring Harbor Laboratory
SP 2022.05.18.492452
DO 10.1101/2022.05.18.492452
A1 A.V. Vakhrusheva
A1 A.V. Kudriavtsev
A1 N.A. Kryuchkov
A1 R.V. Deev
A1 M.E. Frolova
A1 K.A. Blagodatskikh
A1 M. Djonovic
A1 A.A. Nedorubov
A1 E. Odintsova
A1 A.V. Ivanov
A1 E.A. Romanovskaya-Romanko
A1 M.A. Stukova
A1 A.A. Isaev
A1 I.V. Krasilnikov
YR 2022
UL http://biorxiv.org/content/early/2022/05/18/2022.05.18.492452.abstract
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.