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

NCT ID: NCT04898140

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Covid19 Respiratory Viral Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers

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

SARS-CoV-2 specific IgM and IgG detection

Intervention Type 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

Intervention Type 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

Intervention Type 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

Recovered

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

SARS-CoV-2 specific IgM and IgG detection

Intervention Type 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

Intervention Type 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

Intervention Type 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

Vaccinated

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

SARS-CoV-2 specific IgM and IgG detection

Intervention Type 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

Intervention Type 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

Intervention Type 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

Special group

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

SARS-CoV-2 specific IgM and IgG detection

Intervention Type 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

Intervention Type 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

Intervention Type 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

Interventions

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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).

Intervention Type 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.

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NETWORK

Sponsor Role collaborator

Moscow State University of Medicine and Dentistry

OTHER

Sponsor Role collaborator

Moscow Institute of Physics and Technology

UNKNOWN

Sponsor Role collaborator

National Research Center for Hematology, Russia

NETWORK

Sponsor Role collaborator

State Research Center Institute of Immunology, Russia

UNKNOWN

Sponsor Role collaborator

Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAS

UNKNOWN

Sponsor Role collaborator

National Medical Research Center of Phthisiopulmonology and Infectious Diseases

OTHER_GOV

Sponsor Role collaborator

Moscow Department of Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Moscow, , Russia

Site Status

Countries

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Russia

References

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Molodtsov IA, Kegeles E, Mitin AN, Mityaeva O, Musatova OE, Panova AE, Pashenkov MV, Peshkova IO, Alsalloum A, Asaad W, Budikhina AS, Deryabin AS, Dolzhikova IV, Filimonova IN, Gracheva AN, Ivanova OI, Kizilova A, Komogorova VV, Komova A, Kompantseva NI, Kucheryavykh E, Lagutkin Dcapital A, Cyrillic, Lomakin YA, Maleeva AV, Maryukhnich EV, Mohammad A, Murugin VV, Murugina NE, Navoikova A, Nikonova MF, Ovchinnikova LA, Panarina Y, Pinegina NV, Potashnikova DM, Romanova EV, Saidova AA, Sakr N, Samoilova AG, Serdyuk Y, Shakirova NT, Sharova NI, Sheetikov SA, Shemetova AF, Shevkova LV, Shpektor AV, Trufanova A, Tvorogova AV, Ukrainskaya VM, Vinokurov AS, Vorobyeva DA, Zornikova KV, Efimov GA, Khaitov MR, Kofiadi IA, Komissarov AA, Logunov DY, Naigovzina NB, Rubtsov YP, Vasilyeva IA, Volchkov P, Vasilieva E. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific T Cells and Antibodies in Coronavirus Disease 2019 (COVID-19) Protection: A Prospective Study. Clin Infect Dis. 2022 Aug 24;75(1):e1-e9. doi: 10.1093/cid/ciac278.

Reference Type RESULT
PMID: 35435222 (View on PubMed)

Komissarov AA, Dolzhikova IV, Efimov GA, Logunov DY, Mityaeva O, Molodtsov IA, Naigovzina NB, Peshkova IO, Shcheblyakov DV, Volchkov P, Gintsburg AL, Vasilieva E. Boosting of the SARS-CoV-2-Specific Immune Response after Vaccination with Single-Dose Sputnik Light Vaccine. J Immunol. 2022 Mar 1;208(5):1139-1145. doi: 10.4049/jimmunol.2101052. Epub 2022 Jan 31.

Reference Type RESULT
PMID: 35101893 (View on PubMed)

Related Links

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http://gkb-23.ru

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

Other Identifiers

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1027739482649/0908/4_9

Identifier Type: -

Identifier Source: org_study_id

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