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

Sponsor

Moscow Department of Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT04898140

Collaborator

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

6,500

Enrollment

Location

14.4

Anticipated Duration (Months)

452.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Respiratory Viral Infection	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 Design

Study Type:

Observational

Anticipated Enrollment :

6500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 20, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare	Moscow		Russian Federation

Sponsors and Collaborators

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