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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04898140
Recruitment Status : Completed
First Posted : May 24, 2021
Last Update Posted : September 14, 2022
Sponsor:
Collaborators:
Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
Moscow State University of Medicine and Dentistry
Moscow Institute of Physics and Technology
National Research Center for Hematology, Russia
State Research Center Institute of Immunology, Russia
Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAS
National Medical Research Center of Phthisiopulmonology and Infectious Diseases
Information provided by (Responsible Party):
Moscow Department of Health

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Covid19 Respiratory Viral Infection Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes

Study Design
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Study Type : Observational
Actual Enrollment : 5340 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Evaluation of the Intensity of Cellular and Humoral Immunity to COVID-19 Causative Agent in Moscow Residents
Actual Study Start Date : October 20, 2020
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy volunteers
Individuals who were not infected and not having been demonstrated COVID-19 symptoms since December 2019.
 Diagnostic Test: 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).

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.

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
Recovered
Individuals who were recovered from COVID-19 with different severity.
 Diagnostic Test: 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).

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.

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
Vaccinated
Individuals who were vaccinated against SARS-CoV-2 with "Sputnik V" vaccine.
 Diagnostic Test: 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).

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.

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

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.

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


Outcome Measures
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Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Peripheral blood plasma and serum. Peripheral blood mononuclear cells.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Residents of Moscow city over 18 years old
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04898140


Locations
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Russian Federation
Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
Moscow, Russian Federation
Sponsors and Collaborators
Moscow Department of Health
Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
Moscow State University of Medicine and Dentistry
Moscow Institute of Physics and Technology
National Research Center for Hematology, Russia
State Research Center Institute of Immunology, Russia
Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAS
National Medical Research Center of Phthisiopulmonology and Infectious Diseases
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:
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.

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Responsible Party: Moscow Department of Health
ClinicalTrials.gov Identifier: NCT04898140    
Other Study ID Numbers: 1027739482649/0908/4_9
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moscow Department of Health:
Covid19
T cell immunity
virus-specific antibodies
 protective immunity
flow cytometry
ELISpot
Additional relevant MeSH terms:
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COVID-19
Virus Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases