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Completed

NCT Number: NCT04898140

The Evaluation of Cellular and Humoral Immunity to COVID-19 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Respiratory Viral Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Moscow, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SARS-CoV-2 specific IgM and IgG detection

Diagnostic Test

Detection of IgM and IgG antibodies specific to the SARS-CoV-2 antigens in the blood serum using enzyme-linked immunosorbent assay (ELISA).

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

Diagnostic Test

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.

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

Diagnostic Test

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

Primary outcomes

  1. IgM/IgG titer

    Time frame: 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.

  2. Peripheral blood T cells specific to different SARS-CoV-2 proteins

    Time frame: 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.

  3. Subpopulations of SARS-CoV-2 specific peripheral blood T lymphocytes

    Time frame: 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.

  4. Primary or repeated COVID-19 cases

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Moscow Department of Health

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 24, 2021
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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