Immunogenicity evaluation of Gam-COVID-Vac (Sputnik V)

• Published in: Biopreparaty Vol. 22; no. 4; pp. 435 - 445
• Main Authors: Kirillov, I. A., Pirozhkov, A. P., Rubtsov, V. V., Loginova, S. Ya, Saifulina, N. A., Plekhanova, T. M., Timofeev, M. A., Kutaev, D. A., Logunov, D. Y., Gintsburg, A. L., Borisevich, S. V.
• Format: Magazine Article
• Language: English
• Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products 01.12.2022
• Subjects: covid-19, sars-cov-2; elisa; gam-covid-vac; humoral immunity; immunoglobulin g; sputnik v; vaccine; virus neutralising antibodies
• ISSN: 2221-996X; 2619-1156
• DOI: 10.30895/2221-996X-2022-22-4-435-445

In November 2020, the Armed Forces of the Russian Federation began mass immunisation of the personnel with Gam-COVID-Vac (Sputnik V), the first Russia vaccine against the new coronavirus infection (COVID-19). Thus, it became necessary to assess post-vaccination antibody levels and the duration and intensity of humoral immunity to COVID-19. The aim of the study was to investigate the immunogenicity and efficacy of Gam-COVID-Vac in military medical staff after vaccination. Materials and methods: the authors determined the presence of specific antibodies in the serum of individuals immunised with Gam-COVID-Vac (477 volunteers) and COVID-19 convalescents (73 patients), using virus neutralisation (VN), enzyme-linked immunosorbent assay (ELISA) with reagent kits by several manufacturers, and immunoblotting. The results of the study were evaluated using analysis of variance. Results: VN detected virus neutralising antibodies in 90.7% of vaccinated subjects; ELISA, in 95.4%. Both VN and ELISA showed lower antibody levels in the vaccinated over 50 years of age. ELISA demonstrated a significantly higher concentration of anti-SARS-CoV-2 spike IgG in the Gam-COVID-Vac group than in the COVID-19 convalescent group. The correlation between antibody detection results by VN and ELISA was the strongest when the authors used their experimental reagent kit for quantitative detection of virus neutralising antibodies by competitive ELISA with the recombinant human ACE2 receptor. Having analysed the time course of neutralising antibody titres, the authors noted a significant, more than two-fold decrease in geometric means of the titres three months after administration of the second vaccine component. Conclusions: the subjects vaccinated with Gam-COVID-Vac gain effective humoral immunity to COVID-19. The decrease in titres indicates the need for revaccination in 6 months.