Validation of 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response After COVID-19 or Vaccination
Study Details
Study Description
Brief Summary
Accuracy validation of the designed and manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' for detection of SARS-CoV-2-specific T cells.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The investigators enrolled three independent cohorts of vaccinated (n = 69), convalescent (n = 50), and healthy but unvaccinated individuals (n = 101). Further, they estimated the T cell response to the designed peptide antigen panel, as measured by the manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' to detect SARS-CoV-2-specific T cells.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Vaccinated SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment |
Diagnostic Test: Corona-T-test
Corona-T-test - a single-color enzymatic ELISpot kit for the detection of interferon-gamma (IFNɣ), produced by the National Research Center for Hematology aiming detection of SARS-CoV-2-specific T cells
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Convalescents PCR (polymerase chain reaction) confirmed COVID-19 in a period 14-45 days before recruitment |
Diagnostic Test: Corona-T-test
Corona-T-test - a single-color enzymatic ELISpot kit for the detection of interferon-gamma (IFNɣ), produced by the National Research Center for Hematology aiming detection of SARS-CoV-2-specific T cells
|
Healthy donors No self-reported COVID-19 infection |
Diagnostic Test: Corona-T-test
Corona-T-test - a single-color enzymatic ELISpot kit for the detection of interferon-gamma (IFNɣ), produced by the National Research Center for Hematology aiming detection of SARS-CoV-2-specific T cells
|
Outcome Measures
Primary Outcome Measures
- The result of Corona-T-test [1 week]
positive, negative, or inconclusive (gray-zone)
Eligibility Criteria
Criteria
Non-specific inclusion criteria
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Participants aged 18 and above
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Participants agreeing to follow the study procedures
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Participants able to understand the purpose, nature, and methodology of the study
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Participants having signed the informed consent
Healthy donors inclusion criteria
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No self-reported COVID-19 infection
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No vaccination against COVID-19
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No immunoglobulin (Ig) IgM or IgG antibodies against SARS-CoV-2 by three tests (IgM to SARS-CoV-2 detection: "SARS-CoV-2-IgМ-ELISA-BEST", Ref #D-5502, IgG to SARS-CoV-2 S protein detection: "SARS-CoV-2-IgG-quantity-ELISA-BEST", "Vector-Best", Ref #D-5505), IgG to SARS-CoV-2 N protein detection: "SARS-CoV-2 IgG Reagent Kit", ARCHITECT, Abbott Laboratories, EU)
Convalescents inclusion criteria
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Self-reported COVID-19 infection
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PCR confirmed COVID-19 in a period 14-45 days before recruitment
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Detectable IgG antibodies against SARS-CoV-2 (IgG to RBD domain of SARS-CoV-2 S protein detection: "SARS-CoV-2-IgG-ELISA", "National Medical Research Center for Hematology", Moscow, Russia. Ref #K153G)
Vaccinated inclusion criteria
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SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment
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Detectable IgG antibodies against SARS-CoV-2 (IgG to receptor-binding domain (RBD) domain of SARS-CoV-2 S protein: "SARS-CoV-2-IgG-ELISA", "National Medical Research Center for Hematology", Moscow, Russia. Ref #K153G)
Exclusion criteria
- Age under 18 y.o.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | National Research Center for Hematology | Moscow | Russian Federation | 125167 |
Sponsors and Collaborators
- National Research Center for Hematology, Russia
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- DNKOM LLC
Investigators
- Principal Investigator: Grigory A Efimov, MD PhD, National Research Center for Hematology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Corona-T-test