Abstract
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 Statement
A.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.
