Safety and immunogenicity of betuvax-cov-2, an rbd-fc-based sars-cov-2 recombinant vaccine: preliminary results of the first-in-human, randomized, double-blind, placebo-controlled phase i/ii clinical trial

HIGHLIGHTS

SUMMARY

The "Betuvax-CoV-2" vaccine was developed as a subunit vaccine containing a recombinant RBD-Fc fusion_protein absorbed on the surface of the betulin-based spherical nanoparticles ("Betuspheres") mimicking the virus and enhancing the immune_response. The first primary outcome related to immunogenicity and efficacy was the proportion of the volunteers with an at least 4-fold increase in the level of specific humoral immune_response (titers of total anti-SARS-CoV-2 antibodies assessed by ELISA) 21 days after the second administration of the study drug/placebo and 90 ± 5 days after the first administration . . .

 



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