NCT04898140

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

Completed Last updated 14 September 2022

What this trial tests

trial testing SARS-CoV-2 specific IgM and IgG detection in Covid19 in 5,340 participants. Completed in 31 December 2021.

Timeline

20 October 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Moscow Department of Health
Status	Completed
Study type	OBSERVATIONAL
Enrollment	5,340
Start date	20 October 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across Russia

Drugs / interventions tested

• SARS-CoV-2 specific IgM and IgG detection
• ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins
• Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes

Conditions studied

• Covid19 — all drugs for Covid19 →
• Respiratory Viral Infection — all drugs for Respiratory Viral Infection →

Sponsor

Moscow Department of Health

Who can join

18 and older, any sex, with Covid19 or Respiratory Viral Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific T Cells and Antibodies in Coronavirus Disease 2019 (COVID-19) Protection: A Prospective Study.
   Molodtsov IA, Kegeles E, Mitin AN, Mityaeva O, et al · · 2022 · cited 31× · PMID 35435222 · DOI 10.1093/cid/ciac278
2. Boosting of the SARS-CoV-2-Specific Immune Response after Vaccination with Single-Dose Sputnik Light Vaccine.
   Komissarov AA, Dolzhikova IV, Efimov GA, Logunov DY, et al · · 2022 · cited 10× · PMID 35101893 · DOI 10.4049/jimmunol.2101052
3. Coronavirus-Specific Antibody and T Cell Responses Developed after Sputnik V Vaccination in Patients with Chronic Lymphocytic Leukemia.
   Komissarov AA, Kislova M, Molodtsov IA, Petrenko AA, et al · · 2022 · cited 5× · PMID 36613860 · DOI 10.3390/ijms24010416
4. Boosting of the SARS-CoV-2-specific immune response after vaccination with single-dose Sputnik Light vaccine
   Komissarov AA, Dolzhikova IV, Efimov GA, Logunov DY, et al · · 2021 · cited 1× · DOI 10.1101/2021.10.26.21265531
5. SARS-CoV-2 specific T cells and antibodies in COVID-19 protection: a prospective study
   Molodtsov IA, Kegeles E, Mitin AN, Mityaeva O, et al · · 2021 · cited 1× · DOI 10.1101/2021.08.19.21262278