Covid19 Clinical Trial
Official title:
The Evaluation of the Intensity of Cellular and Humoral Immunity to COVID-19 Causative Agent in Moscow Residents
Verified date | September 2022 |
Source | Moscow Department of Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 5340 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare | Moscow |
Lead Sponsor | Collaborator |
---|---|
Moscow Department of Health | Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare, Moscow Institute of Physics and Technology, Moscow State University of Medicine and Dentistry, National Medical Research Center of Phthisiopulmonology and Infectious Diseases, National Research Center for Hematology, Russia, Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAS, State Research Center Institute of Immunology, Russia |
Russian Federation,
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 Sputn — View 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, — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 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. |
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