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
1 other identifier
observational
5,340
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2020
CompletedFirst Submitted
Initial submission to the registry
May 21, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 14, 2022
September 1, 2022
1.2 years
May 21, 2021
September 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
IgM/IgG titer
The level of SARS-CoV-2 specific IgM/IgG antibodies in blood serum.
At the moment of inclusion and for 1-2 years after inclusion in the study.
Peripheral blood T cells specific to different SARS-CoV-2 proteins
The number of peripheral blood T cells specific to N, M or S protein of SARS-CoV-2.
At the moment of inclusion and for 1-2 years after inclusion in the study.
Subpopulations of SARS-CoV-2 specific peripheral blood T lymphocytes
The number of peripheral blood T-helpers and cytotoxic T cells specific to SARS-CoV-2 coronavirus antigens.
At the moment of inclusion and for 1-2 years after inclusion in the study.
Primary or repeated COVID-19 cases
Monitoring of the SARS-CoV-2 infection cases, severity of symptoms, outcomes and recovery period among participants included into the study.
1-2 years after inclusion in the study.
Study Arms (4)
Healthy volunteers
Individuals who were not infected and not having been demonstrated COVID-19 symptoms since December 2019.
Recovered
Individuals who were recovered from COVID-19 with different severity.
Vaccinated
Individuals who were vaccinated against SARS-CoV-2 with "Sputnik V" vaccine.
Special group
Individuals who recovered from COVID-19 concomitant with other immune-related comorbidities (tuberculosis, chronic obstructive pulmonary disease, HIV infection, hematological neoplasia).
Interventions
Detection of IgM and IgG antibodies specific to the SARS-CoV-2 antigens in the blood serum using enzyme-linked immunosorbent assay (ELISA).
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.
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
Residents of Moscow city over 18 years old
You may qualify if:
- residents of the Moscow city (registered in Moscow);
- years old or above;
- signed informed consent.
You may not qualify if:
- citizenship of a foreign state;
- refusal to sign the informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moscow Department of Healthlead
- Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcarecollaborator
- Moscow State University of Medicine and Dentistrycollaborator
- Moscow Institute of Physics and Technologycollaborator
- National Research Center for Hematology, Russiacollaborator
- State Research Center Institute of Immunology, Russiacollaborator
- Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAScollaborator
- National Medical Research Center of Phthisiopulmonology and Infectious Diseasescollaborator
Study Sites (1)
Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
Moscow, Russia
Related Publications (2)
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.
PMID: 35435222RESULTKomissarov 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.
PMID: 35101893RESULT
Related Links
Biospecimen
Peripheral blood plasma and serum. Peripheral blood mononuclear cells.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2021
First Posted
May 24, 2021
Study Start
October 20, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
September 14, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share