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

Completed

• Conditions: Covid19; Respiratory Viral Infection
• Interventions: Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection

• Registration Number: NCT04898140
• Lead Sponsor: Moscow Department of Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-20
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5340

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	SARS-CoV-2 specific IgM and IgG detection	Individuals who were not infected and not having been demonstrated COVID-19 symptoms since December 2019.
Recovered	SARS-CoV-2 specific IgM and IgG detection	Individuals who were recovered from COVID-19 with different severity.
Vaccinated	SARS-CoV-2 specific IgM and IgG detection	Individuals who were vaccinated against SARS-CoV-2 with "Sputnik V" vaccine.
Special group	SARS-CoV-2 specific IgM and IgG detection	Individuals who recovered from COVID-19 concomitant with other immune-related comorbidities (tuberculosis, chronic obstructive pulmonary disease, HIV infection, hematological neoplasia).

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

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