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

About authors

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

About paper

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.

Received: 2021-09-29 Accepted: 2021-10-13 Published online: 2021-10-17
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Fig. 1. Patients' distribution based on the disease severity for the assessed checkpoints (bed-days)
Fig. 2. Distribution of mutations in the RBD domain of SARS-CoV-2 viruses
Fig. 3. Comparative assessment of viral load in biological samples of vaccinated and unvaccinated patients, carrying mutations in the RBD domain
Fig. 4. Comparative assessment of the titers of neutralizing antibodies against different SARS-CoV-2 variants. * — upper row is represented by p-values with 95% confidence interval (Wilcoxon test)
Table 1. General characteristics of patients
Note: * — significant differences between groups (p < 0.05).
Table 2. Assessment of dynamic changes in COVID-19 course severity in vaccinated and unvaccinated patients
Table 3. Viral load in vaccinated and unvaccinated patients
Note: * — significant differences for the sample (vaccinated n = 22, unvaccinated n = 35) (p < 0.05).
Table 4. Comparison of anti-RBD antibody levels in vaccinated and unvaccinated patients
Note: * — significant differences (p < 0.05).
Table 5. RBD domain mutation rate in the groups being compared
Note: * — р = 0.020 (Fisher's exact test).
Table 6. Levels of virus neutralizing antibodies (VNA) against the variants of SARS-CoV-2 mutations