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Validation of 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response After COVID-19 or Vaccination

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ClinicalTrials.gov Identifier: NCT05165719
Recruitment Status : Completed
First Posted : December 21, 2021
Last Update Posted : December 21, 2021
Sponsor:
Collaborators:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
DNKOM LLC
Information provided by (Responsible Party):
National Research Center for Hematology, Russia

Study Description
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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
SARS-CoV-2 Infection SARS-CoV-2 Vaccination Diagnostic Test: Corona-T-test

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
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Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Specificity, Sensitivity, and Accuracy for an ELISpot-based In-vitro Diagnostic (IVD) Kit 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response
Actual Study Start Date : July 7, 2021
Actual Primary Completion Date : September 21, 2021
Actual Study Completion Date : November 20, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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
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Primary Outcome Measures :
  1. The result of Corona-T-test [ Time Frame: 1 week ]
    positive, negative, or inconclusive (gray-zone)


Biospecimen Retention:   Samples With DNA
frozen blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The attendees of the LTT 'DNKOM' were screened for the inclusion/exclusion criteria with a questionnaire and the above-mentioned serology tests.
Criteria

Non-specific inclusion criteria

  • Participants aged 18 and above
  • Participants agreeing to follow the study procedures
  • Participants able to understand the purpose, nature, and methodology of the study
  • Participants having signed the informed consent

Healthy donors inclusion criteria

  • No self-reported COVID-19 infection
  • No vaccination against COVID-19
  • 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

  • Self-reported COVID-19 infection
  • PCR confirmed COVID-19 in a period 14-45 days before recruitment
  • 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

  • SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05165719


Locations
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Russian Federation
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
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Principal Investigator: Grigory A Efimov, MD PhD National Research Center for Hematology
More Information
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Responsible Party: National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT05165719    
Other Study ID Numbers: Corona-T-test
First Posted: December 21, 2021    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases