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

Moscow Department of Health

Status: Completed

Conditions: Covid19; Respiratory Viral Infection

Treatments: Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection; Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes; Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT04898140

1027739482649/0908/4_9

Details and patient eligibility

About

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.

Enrollment: 5,340 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

5,340 participants in 4 patient groups

Healthy volunteers

Description:

Individuals who were not infected and not having been demonstrated COVID-19 symptoms since December 2019.

Treatment:

Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection

Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes

Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins

Recovered

Description:

Individuals who were recovered from COVID-19 with different severity.

Treatment:

Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection

Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes

Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins

Vaccinated

Description:

Individuals who were vaccinated against SARS-CoV-2 with "Sputnik V" vaccine.

Treatment:

Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection

Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes

Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins

Special group

Description:

Individuals who recovered from COVID-19 concomitant with other immune-related comorbidities (tuberculosis, chronic obstructive pulmonary disease, HIV infection, hematological neoplasia).

Treatment:

Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection

Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes

Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins