Covid19NCT04898140
The Evaluation of Cellular and Humoral Immunity to COVID-19 in Moscow Residents
An observational study of Covid19 and Respiratory Viral Infection, run by Moscow Department of Health at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Respiratory Viral Infection
- What is being tested?
- SARS-CoV-2 specific IgM and IgG detection, ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins and Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes
- Type of treatment
- Vaccines
- How many people
- 5,340 participants
- Where
- 1 siteRussia
- Study dates
- 20 Oct 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Moscow city over 18 years old
Who may be able to join
- residents of the Moscow city (registered in Moscow);
- 18 years old or above;
- signed informed consent.
Who cannot join
- citizenship of a foreign state;
- refusal to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare
Moscow
About this study
Official title: The Evaluation of the Intensity of Cellular and Humoral Immunity to COVID-19 Causative Agent in Moscow Residents
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.
- Conditions
- Covid19, Respiratory Viral Infection
- Being 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
- Keywords
- Covid19, T cell immunity, virus-specific antibodies, protective immunity, flow cytometry, ELISpot
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 specific IgM and IgG detectionDiagnostic test
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 proteinsDiagnostic test
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 lymphocytesDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Individuals who were not infected and not having been demonstrated COVID-19 symptoms since December 2019. Receives: Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection; Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins; Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes | |
| Recovered | Individuals who were recovered from COVID-19 with different severity. Receives: Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection; Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins; Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes | |
| Vaccinated | Individuals who were vaccinated against SARS-CoV-2 with "Sputnik V" vaccine. Receives: Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection; Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins; Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes | |
| Special group | Individuals who recovered from COVID-19 concomitant with other immune-related comorbidities (tuberculosis, chronic obstructive pulmonary disease, HIV infection, hematological neoplasia). Receives: Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection; Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins; Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgM/IgG titer
The level of SARS-CoV-2 specific IgM/IgG antibodies in blood serum.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-2 years after inclusion in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start20 Oct 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Department of Health
- Sponsor type
- Other government
- Collaborators
- Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare, Moscow State University of Medicine and Dentistry, Moscow Institute of Physics and Technology, National Research Center for Hematology, Russia, State Research Center Institute of Immunology, Russia, Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAS, National Medical Research Center of Phthisiopulmonology and Infectious Diseases
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898140
- Sponsor's protocol ID
- 1027739482649/0908/4_9
- Status last verified
- Sep 2022
- First submitted
- 21 May 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35435222Komissarov 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.
PubMed 35101893
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Intensity of Cellular and Humoral Immunity to COVID-19 Causative Agent in Moscow Residents
- ClinicalTrials.gov ID
- NCT04898140
- Acronym / sponsor ID
- 1027739482649/0908/4_9
- Conditions
- Covid19, Respiratory Viral Infection
- Keywords
- Covid19, T cell immunity, virus-specific antibodies, protective immunity, flow cytometry, ELISpot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,340 participants (actual)
- Lead sponsor
- Moscow Department of HealthOther government
- Collaborators
- Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare, Moscow State University of Medicine and Dentistry, Moscow Institute of Physics and Technology, National Research Center for Hematology, Russia, State Research Center Institute of Immunology, Russia, Shemyakin-Ovchinnikov Institute of bioorganic chemistry RAS, National Medical Research Center of Phthisiopulmonology and Infectious Diseases
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection, Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins, Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytesIndividuals who were not infected and not having been demonstrated COVID-19 symptoms since December 2019. |
| Recovered | – | Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection, Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins, Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytesIndividuals who were recovered from COVID-19 with different severity. |
| Vaccinated | – | Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection, Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins, Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytesIndividuals who were vaccinated against SARS-CoV-2 with "Sputnik V" vaccine. |
| Special group | – | Diagnostic Test: SARS-CoV-2 specific IgM and IgG detection, Diagnostic Test: ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins, Diagnostic Test: Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytesIndividuals who recovered from COVID-19 concomitant with other immune-related comorbidities (tuberculosis, chronic obstructive pulmonary disease, HIV infection, hematological neoplasia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Moscow city over 18 years old
Key inclusion criteria (3 listed)
- residents of the Moscow city (registered in Moscow);
- 18 years old or above;
- signed informed consent.
Key exclusion criteria (2 listed)
- citizenship of a foreign state;
- refusal to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 specific IgM and IgG detectionDetection of IgM and IgG antibodies specific to the SARS-CoV-2 antigens in the blood serum using enzyme-linked immunosorbent assay (ELISA). | Diagnostic test | Healthy volunteers, Recovered, Special group, Vaccinated |
| ELISpot: detection of the T cells specific to different SARS-CoV-2 proteinsDetection 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. | Diagnostic test | Healthy volunteers, Recovered, Special group, Vaccinated |
| Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytesDetection 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 | Diagnostic test | Healthy volunteers, Recovered, Special group, Vaccinated |
Primary outcome
IgM/IgG titer
Time frame: At the moment of inclusion and for 1-2 years after inclusion in the study.
The level of SARS-CoV-2 specific IgM/IgG antibodies in blood serum.
Peripheral blood T cells specific to different SARS-CoV-2 proteins
Time frame: At the moment of inclusion and for 1-2 years after inclusion in the study.
The number of peripheral blood T cells specific to N, M or S protein of SARS-CoV-2.
Subpopulations of SARS-CoV-2 specific peripheral blood T lymphocytes
Time frame: At the moment of inclusion and for 1-2 years after inclusion in the study.
The number of peripheral blood T-helpers and cytotoxic T cells specific to SARS-CoV-2 coronavirus antigens.
Primary or repeated COVID-19 cases
Time frame: 1-2 years after inclusion in the study.
Monitoring of the SARS-CoV-2 infection cases, severity of symptoms, outcomes and recovery period among participants included into the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Results publication: PubMed 35435222Molodtsov 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.
- Results publication: PubMed 35101893Komissarov 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.
- Official website of Clinical City Hospital named after I.V. Davydovsky of Moscow Department of HealthcareLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Respiratory Viral Infection, run by Moscow Department of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgM/IgG titer (time frame: At the moment of inclusion and for 1-2 years after inclusion in the study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04898140, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.