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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04898140
Enrollment
5340
Registered
2021-05-24
Start date
2020-10-20
Completion date
2021-12-31
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Respiratory Viral Infection

Keywords

Covid19, T cell immunity, virus-specific antibodies, protective immunity, flow cytometry, ELISpot

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.

Interventions

DIAGNOSTIC_TESTSARS-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_TESTELISpot: 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_TESTFlow 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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
IgM/IgG titerAt 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 proteinsAt 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 lymphocytesAt 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 cases1-2 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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026