ORIGINAL RESEARCH
Assessment of COVID-19 clinical course in patients vaccinated with Spitnik V, SARS-CoV-2 S protein RBD domain variation and serum virus neutralizing activity
1 Gamaleya National Research Center for Epidemiology and Microbiology, Moscow, Russia
2 Peoples’ Friendship University of Russia, Moscow, Russia
3 Infectious Clinical Hospital № 1, Moscow, Russia
4 Lomonosov Moscow State University, Moscow, Russia
Correspondence should be addressed: Ludmila V. Kolobukhina
Gamaleya St. 18, Moscow, 123098; ur.xednay@anihcubolokl
Acknowledgements: we would like to thank Antipyat NA, Deputy Chief Physician for Medical Affairs, and Bazarova MV, PhD, Deputy Chief Physician for Sanitary and Epidemiological Issues, Infectious Clinical Hospital № 1, for the study management and support.
Author contributions: Kolobukhina LV — study proponent, design, manuscript writing, clinical research management; Burgasova OA — literature analysis, manuscript writing and editing, clinical research data processing; Kruzhkova IS — clinical observation, literature analysis, processing of the results; Bakalin VV — clinical observation, clinical and laboratory data processing; Generalova LV — clinical data processing; Shagaev AV — monitoring of infected individuals after vaccination; Ogarkova DA — statistical analysis; Nikiforova MA — coordination of virological studies, virus isolation and VNA; Vasina DV — ELISA data processing, coordination of immunological studies; Gushchin VA — study concept, molecular biological and virological research management; Smetanina SV — clinical research general management.
Compliance with ethical standards: the study was approved by the Ethics Committee of Moscow Infectious Clinical Hospital (protocol № 11/А dated November 16, 2020). The informed consent was submitted by all patients.
- Kolobukhina LV, Burgasova OA, Kraeva LA, Gushchin VA, Burtseva EI, Kruzhkova IS, et al. Clinical and laboratory profile of patients with COVID-19 hospitalized in an infectious hospital in Moscow in the period from May to July 2020. Infectious diseases. 2021; 19 (2): 5–15. Russian.
- Rzymski P, Pazgan-Simon M, Krzysztof Simon T, ZarębskaMichaluk D, Szczepańska B, et al. Clinical Characteristics of Hospitalized COVID-19 Patients Who Received at Least One Dose of COVID-19 Vaccine. 2021; 9 (7): 78. Available from: https://www.mdpi.com/2076-393X/9/7/781.
- Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. Safety and efficacy of an RAD26 and RAD5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. The Lancet. 2021; 397 (10275): 671.
- Statistics and Research Coronavirus (COVID-19) Vaccinations. Available from: https://ourworldindata.org/covid-vaccinations.
- Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020; 20 (5): 533– 4. DOI: 10.1016/S1473-3099(20)30120-1. Erratum in: Lancet Infect Dis. 2020 Sep; 20 (9): e215.
- Haas EJ, Angulo FJ, McLaughlin JM, Anis E, Singer SR, Khan F, et al. Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data. Lancet. 2021; 397 (10287): 1819–829. DOI: 10.1016/S01406736(21)00947-8.
- Hodick G, Tene L, Rotem RS, Patalon T, Gazit S, Ben-Tov A, et al. The effectiveness of the TWO-DOSE BNT162b2 vaccine: analysis of real-world data. Clin Infect Dis. 2021; ciab438. DOI: 10.1093/ cid/ciab438. Epub ahead of print. PMID: 33999127.
- Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. The Lancet. 2020; 396 (10255): 887–97.
- Keehner J, et al. SARS-CoV-2 Infection after Vaccination in Health Care Workers in California. N Engl J Med. 2021; 384: 1774–5. DOI: 10.1056/NEJMc2101927.
- NEWS (or NEWS2) score when assessing possible COVID-19 patients in primary care. Available from: https://www.cebm. net/covid-19/should-we-use-the-news-or-news2-score-whenassessing-patients-with-possible-covid-19-in-primary-care/.
- Amanat F, White KM, Miorin L, Strohmeier S, McMahon M, Meade P, et al. An In Vitro Microneutralization Assay for SARS-CoV-2 Serology and Drug Screening. Curr Protoc Microbiol. 2020; 58 (1): e108. DOI: 10.1002/cpmc.108.
- V kakih stranah vakcina "Sputnik V" odobrena k primeneniju. Dostupno po ssylke: https://sputnik-meedia.ee/ infographics/20210607/573214/V-kakikh-stranakh-vaktsinaSputnik-V-odobrena-k-primeneniyu.html. Russian.
- Statistika vakcinacii ot koronavirusa (COVID-19) v Rossii. Dostupno po ssylke: https://index.minfin.com.ua/reference/ coronavirus/vaccination/russia/. Russian.
- Schmidt F, Weisblum Y, Muecksch F, et al. Measuring SARS-CoV-2 neutralizing antibody activity using pseudotyped and chimeric viruses. J Exp Med. 2020; 217 (11): e20201181–e20201181.
- Diamond M, Chen R, Xie X, Case J, Zhang X, VanBlargan L, et al. SARS-CoV-2 variants show resistance to neutralization by many monoclonal and serum-derived polyclonal antibodies. Res Sq. 2021; 3: 228079. DOI: 10.21203/rs.3.rs-228079/v1. Preprint.