Clinical trial NCT04898140: The Evaluation of Cellular and Humoral Immunity to COVID-19 in Moscow Residents
Official title: The Evaluation of the Intensity of Cellular and Humoral Immunity to COVID-19 Causative Agent in Moscow Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Respiratory Viral Infection
Keywords: Covid19
T cell immunity
virus-specific antibodies
protective immunity
flow cytometry
ELISpot
Lead sponsor: Moscow Department of Health
Sponsor class: OTHER_GOV
Collaborators: name: Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
name: Moscow State University of Medicine and Dentistry
name: Moscow Institute of Physics and Technology
name: National Research Center for Hematology, Russia
name: State Research Center Institute of Immunology, Russia
name: Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAS
name: National Medical Research Center of Phthisiopulmonology and Infectious Diseases
First posted: 2021-05-24
Enrollment: 5340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Moscow city over 18 years old

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.


Eligibility 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.

Primary outcomes:
measure: IgM/IgG titer
timeFrame: At the moment of inclusion and for 1-2 years after inclusion in the study.
measure: Peripheral blood T cells specific to different SARS-CoV-2 proteins
timeFrame: At the moment of inclusion and for 1-2 years after inclusion in the study.
measure: Subpopulations of SARS-CoV-2 specific peripheral blood T lymphocytes
timeFrame: At the moment of inclusion and for 1-2 years after inclusion in the study.
measure: Primary or repeated COVID-19 cases
timeFrame: 1-2 years after inclusion in the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
Study officials:
References:
citation: 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.
citation: 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.