The Evaluation of Cellular and Humoral Immunity to COVID-19 in Moscow Residents
NCT ID: NCT04898140
Last Updated: 2022-09-14
Study Results
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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COMPLETED
5340 participants
OBSERVATIONAL
2020-10-20
2021-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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
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
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
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
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
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
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
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
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
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
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).
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.
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
Eligibility Criteria
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Inclusion Criteria
* 18 years old or above;
* signed informed consent.
Exclusion Criteria
* refusal to sign the informed consent.
18 Years
ALL
Yes
Sponsors
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Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
NETWORK
Moscow State University of Medicine and Dentistry
OTHER
Moscow Institute of Physics and Technology
UNKNOWN
National Research Center for Hematology, Russia
NETWORK
State Research Center Institute of Immunology, Russia
UNKNOWN
Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAS
UNKNOWN
National Medical Research Center of Phthisiopulmonology and Infectious Diseases
OTHER_GOV
Moscow Department of Health
OTHER_GOV
Responsible Party
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Locations
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Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
Moscow, , Russia
Countries
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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.
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.
Related Links
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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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