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

The COVID-19-associated mortality remains high. Studying the features of the COVID-19 course in vaccinated patients, who have got ill on different dates after vaccination, compared to unvaccinated individuals is relevant. The study was aimed to assess clinical and immunological features of the COVID-19 course, as well as to assess humoral immunity (virus neutralizing activity, VNA) and SARS-CoV-2 S protein RBD domain variation in the groups of patients, previously vaccinated with Sputnik V, and unvaccinated patients. A total of 251 patients with confirmed diagnosis of COVID-19 were enrolled, of them 116 individuals were previously vaccinated with one or two Sputnik V vaccine components, and 135 patients were not vaccinated (comparison group). Individuals over 50 years of age prevailed (82.8%). The patients, who received two vaccine components, had mild to moderate COVID-19 (92.1%). In the group of unvaccinated patients, 11 individuals received treatment in the ICU, 10 of them died. The viral load was significantly lower in vaccinated patients. Mutations of SARS-CoV-2, such as S477N, S477N+A522S, E484K and E484K+S494P, were identified both in vaccinated and unvaccinated patients. Assessment of the neutralizing activity of sera revealed no significant differences in VNA against different variants of SARS-CoV-2 mutations. The data obtained demonstrate that the lack of vaccination is an aggravating factor and is capable of increasing the risk of severe course and death in patients with COVID-19.

Keywords: vaccine, COVID-19, Sputnik V, vaccination, patients