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

Covid19 Clinical Trial

Official title:

The Evaluation of the Intensity of Cellular and Humoral Immunity to COVID-19 Causative Agent in Moscow Residents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04898140
• Other study ID #: 1027739482649/0908/4_9
• Status: Completed
• Start date: October 20, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2022
• Source: Moscow Department of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Respiratory Viral Infection
• Virus Diseases

Intervention

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).
• 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

Locations

Country	Name	City	State
Russian Federation	Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare	Moscow

Sponsors (8)

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

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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

Outcome

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.

External Links

•   Official website of Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare