Comparative Analysis of the Neutralizing Capacity of Monovalent and Bivalent Formulations of Betuvax-CoV-2, a Subunit Recombinant COVID-19 Vaccine, Against Various Strains of SARS-CoV-2.

Autor:	Vakhrusheva AV; Betuvax, 119571 Moscow, Russia., Romanovskaya-Romanko EA; Department of Vaccinology, Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 Saint Petersburg, Russia., Stukova MA; Department of Vaccinology, Smorodintsev Research Institute of Influenza, Ministry of Health of the Russian Federation, 197376 Saint Petersburg, Russia., Sukhova MM; Betuvax, 119571 Moscow, Russia., Kuznetsova KS; Betuvax, 119571 Moscow, Russia., Kudriavtsev AV; Research Institute for Systems Biology and Medicine, 117246 Moscow, Russia., Frolova ME; Artgen Biotech, 119571 Moscow, Russia., Ivanishin TV; Betuvax, 119571 Moscow, Russia., Krasilnikov IV; Biotechnology Developments, 119571 Moscow, Russia., Isaev AA; Artgen Biotech, 119571 Moscow, Russia.
Jazyk:	angličtina
Zdroj:	Vaccines [Vaccines (Basel)] 2024 Oct 21; Vol. 12 (10). Date of Electronic Publication: 2024 Oct 21.
DOI:	10.3390/vaccines12101200
Abstrakt:	SARS-CoV-2, the causal agent of the COVID-19 pandemic, is characterized by rapid evolution, which poses a significant public health challenge. Effective vaccines that provide robust protection, elicit strong immune responses, exhibit favorable safety profiles, and enable cost-effective large-scale production are crucial. The RBD-Fc-based Betuvax-CoV-2 vaccine has previously demonstrated a favorable safety profile and induced a significant anti-SARS-CoV-2 humoral immune response in clinical trials. Due to the rapid evolution and emergence of new SARS-CoV-2 strains, the relevance of bivalent vaccine formulations has increased. Methods: This study compared the neutralizing capacity of monovalent and bivalent vaccine formulations against different SARS-CoV-2 strains detected with a SARS-CoV-2 microneutralization assay (MNT). Findings: The monovalent Wuhan-based vaccine generated neutralizing antibodies against the Wuhan and Omicron BA.2 variants but not the distinct Omicron BQ.1 strain. Conversely, the monovalent BA.2-based vaccine induced neutralizing antibodies against both Omicron strains but not Wuhan. While the bivalent Wuhan and BA.2-based vaccine was effective against strains containing the same antigens, it was insufficient to neutralize the distinctive BQ.1 strain at a small dosage. Interpretation: These findings suggest that the vaccine composition should closely match the circulating SARS-CoV-2 strain to elicit the optimal neutralizing antibody response and include the appropriate dosage. Moreover, this study did not find additional advantages of using the bivalent form over the monovalent form for the vaccination against a single prevailing SARS-CoV-2 strain. Competing Interests: A.A.I., I.V.K., M.E.F., A.V.K., and A.V.V. have author’s rights to the patents RU2749193 and RU2795160 (registered by Betuvax). E.A.R.-R. and M.A.S. had received payment from the company Betuvax for providing the experiment. A.A.I., I.V.K., M.E.F., A.V.K., A.V.V., and T.V.I. are shareholders of Betuvax. A.V.V., T.V.I., M.M.S., and K.S.K. are employees of Betuvax. A.A.I., as the founder of Artgen Biotech, provided the funding, participated in the design of this study, and in the decision to publish the results. The funders participated in the design of this study, the writing of the manuscript, and the decision to publish the results.
Databáze:	MEDLINE
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