The Evaluation of Cellular and Humoral Immunity to COVID-19 in Moscow Residents

The Evaluation of the Intensity of Cellular and Humoral Immunity to COVID-19 Causative Agent in Moscow Residents

The aim of the research is to estimate the levels of cellular and humoral immunity to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among Moscow residents over 18 years old. During the study, participants will be divided into four groups: healthy volunteers; individuals recovered from coronavirus disease 2019 (COVID-19) with different severity; individuals vaccinated against SARS-CoV-2; individuals who have had COVID-19 concomitantly with comorbidities that characterized by the impact on the immune system (tuberculosis, chronic obstructive pulmonary disease, HIV infection, hematological neoplasia). For all participants included into the study peripheral blood will be collected and the titers of SARS-CoV-2 specific immunoglobulins M (IgM) and immunoglobulins G (IgG), frequencies of the T cells specific to nucleocapsid (N), membrane (M), and spike (S) proteins of SARS-CoV-2 in peripheral blood, as well as the fractions of virus specific T helpers and cytotoxic T cells will be estimated. For smaller cohorts of the participants in all groups the antibody titers and T cell response levels will be examined in dynamics. All participants will be monitored for the incidence of primary or repeated COVID-19 for 1-2 years after inclusion in the study.

Based on the results of the study, the relationship between the formation of humoral and cellular immunity against COVID-19, the duration of these types of immunity, as well as their individual contribution to protection against primary or secondary SARS-CoV-2 infection will be analyzed. Additionally, data concerning patients recovered from COVID-19 and having concomitant diseases will provide a valuable information that may help to understand in more details the mechanisms of the development of the SARS-CoV-2 specific immune response.

Study Overview

• Status: Completed
• Conditions: Covid19; Respiratory Viral Infection
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 specific IgM and IgG detection; Diagnostic test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins; Diagnostic test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes

• Study Type: Observational
• Enrollment (Actual): 5340

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Residents of Moscow city over 18 years old

Description

Inclusion Criteria:

• residents of the Moscow city (registered in Moscow);
• 18 years old or above;
• signed informed consent.

Exclusion Criteria:

• citizenship of a foreign state;
• refusal to sign the informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers; Individuals who were not infected and not having been demonstrated COVID-19 symptoms since December 2019.	Diagnostic test: SARS-CoV-2 specific IgM and IgG detection; Detection of IgM and IgG antibodies specific to the SARS-CoV-2 antigens in the blood serum using enzyme-linked immunosorbent assay (ELISA).; Diagnostic test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins; Detection of peripheral blood T lymphocytes which are activated and secrete interferon gamma (IFNgamma) upon stimulation with peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, or spike glycoprotein S proteins of SARS-CoV-2 coronavirus.; Diagnostic test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes; Detection of peripheral blood T-helpers (CD45+CD3+CD4+)* and cytotoxic T cells (CD45+CD3+CD8+)* which are activated and secrete IFNgamma and/or interleukin-2 (IL2) upon stimulation with mixture of peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, and spike glycoprotein S proteins of SARS-CoV-2 coronavirus. * CD, cluster of differentiation
Recovered; Individuals who were recovered from COVID-19 with different severity.	Diagnostic test: SARS-CoV-2 specific IgM and IgG detection; Detection of IgM and IgG antibodies specific to the SARS-CoV-2 antigens in the blood serum using enzyme-linked immunosorbent assay (ELISA).; Diagnostic test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins; Detection of peripheral blood T lymphocytes which are activated and secrete interferon gamma (IFNgamma) upon stimulation with peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, or spike glycoprotein S proteins of SARS-CoV-2 coronavirus.; Diagnostic test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes; Detection of peripheral blood T-helpers (CD45+CD3+CD4+)* and cytotoxic T cells (CD45+CD3+CD8+)* which are activated and secrete IFNgamma and/or interleukin-2 (IL2) upon stimulation with mixture of peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, and spike glycoprotein S proteins of SARS-CoV-2 coronavirus. * CD, cluster of differentiation
Vaccinated; Individuals who were vaccinated against SARS-CoV-2 with "Sputnik V" vaccine.	Diagnostic test: SARS-CoV-2 specific IgM and IgG detection; Detection of IgM and IgG antibodies specific to the SARS-CoV-2 antigens in the blood serum using enzyme-linked immunosorbent assay (ELISA).; Diagnostic test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins; Detection of peripheral blood T lymphocytes which are activated and secrete interferon gamma (IFNgamma) upon stimulation with peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, or spike glycoprotein S proteins of SARS-CoV-2 coronavirus.; Diagnostic test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes; Detection of peripheral blood T-helpers (CD45+CD3+CD4+)* and cytotoxic T cells (CD45+CD3+CD8+)* which are activated and secrete IFNgamma and/or interleukin-2 (IL2) upon stimulation with mixture of peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, and spike glycoprotein S proteins of SARS-CoV-2 coronavirus. * CD, cluster of differentiation
Special group; Individuals who recovered from COVID-19 concomitant with other immune-related comorbidities (tuberculosis, chronic obstructive pulmonary disease, HIV infection, hematological neoplasia).	Diagnostic test: SARS-CoV-2 specific IgM and IgG detection; Detection of IgM and IgG antibodies specific to the SARS-CoV-2 antigens in the blood serum using enzyme-linked immunosorbent assay (ELISA).; Diagnostic test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins; Detection of peripheral blood T lymphocytes which are activated and secrete interferon gamma (IFNgamma) upon stimulation with peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, or spike glycoprotein S proteins of SARS-CoV-2 coronavirus.; Diagnostic test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes; Detection of peripheral blood T-helpers (CD45+CD3+CD4+)* and cytotoxic T cells (CD45+CD3+CD8+)* which are activated and secrete IFNgamma and/or interleukin-2 (IL2) upon stimulation with mixture of peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, and spike glycoprotein S proteins of SARS-CoV-2 coronavirus. * CD, cluster of differentiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgM/IgG titer	The level of SARS-CoV-2 specific IgM/IgG antibodies in blood serum.	At the moment of inclusion and for 1-2 years after inclusion in the study.
Peripheral blood T cells specific to different SARS-CoV-2 proteins	The number of peripheral blood T cells specific to N, M or S protein of SARS-CoV-2.	At the moment of inclusion and for 1-2 years after inclusion in the study.
Subpopulations of SARS-CoV-2 specific peripheral blood T lymphocytes	The number of peripheral blood T-helpers and cytotoxic T cells specific to SARS-CoV-2 coronavirus antigens.	At the moment of inclusion and for 1-2 years after inclusion in the study.
Primary or repeated COVID-19 cases	Monitoring of the SARS-CoV-2 infection cases, severity of symptoms, outcomes and recovery period among participants included into the study.	1-2 years after inclusion in the study.

Collaborators and Investigators

• Sponsor: Moscow Department of Health
• Collaborators: Moscow State University of Medicine and Dentistry; National Research Center for Hematology, Russia; National Medical Research Center of Phthisiopulmonology and Infectious Diseases; Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare; Moscow Institute of Physics and Technology; State Research Center Institute of Immunology, Russia; Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAS

Publications and helpful links

General Publications

• Molodtsov IA, Kegeles E, Mitin AN, Mityaeva O, Musatova OE, Panova AE, Pashenkov MV, Peshkova IO, Alsalloum A, Asaad W, Budikhina AS, Deryabin AS, Dolzhikova IV, Filimonova IN, Gracheva AN, Ivanova OI, Kizilova A, Komogorova VV, Komova A, Kompantseva NI, Kucheryavykh E, Lagutkin Dcapital A, Cyrillic, Lomakin YA, Maleeva AV, Maryukhnich EV, Mohammad A, Murugin VV, Murugina NE, Navoikova A, Nikonova MF, Ovchinnikova LA, Panarina Y, Pinegina NV, Potashnikova DM, Romanova EV, Saidova AA, Sakr N, Samoilova AG, Serdyuk Y, Shakirova NT, Sharova NI, Sheetikov SA, Shemetova AF, Shevkova LV, Shpektor AV, Trufanova A, Tvorogova AV, Ukrainskaya VM, Vinokurov AS, Vorobyeva DA, Zornikova KV, Efimov GA, Khaitov MR, Kofiadi IA, Komissarov AA, Logunov DY, Naigovzina NB, Rubtsov YP, Vasilyeva IA, Volchkov P, Vasilieva E. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific T Cells and Antibodies in Coronavirus Disease 2019 (COVID-19) Protection: A Prospective Study. Clin Infect Dis. 2022 Aug 24;75(1):e1-e9. doi: 10.1093/cid/ciac278.
• Komissarov AA, Dolzhikova IV, Efimov GA, Logunov DY, Mityaeva O, Molodtsov IA, Naigovzina NB, Peshkova IO, Shcheblyakov DV, Volchkov P, Gintsburg AL, Vasilieva E. Boosting of the SARS-CoV-2-Specific Immune Response after Vaccination with Single-Dose Sputnik Light Vaccine. J Immunol. 2022 Mar 1;208(5):1139-1145. doi: 10.4049/jimmunol.2101052. Epub 2022 Jan 31.

Helpful Links

• Official website of Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Covid19; flow cytometry; T cell immunity; ELISpot; virus-specific antibodies; protective immunity
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Virus Diseases
• Other Study ID Numbers: 1027739482649/0908/4_9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No