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

NCT ID: NCT05165719

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-07

Study Completion Date

2021-11-20

Brief Summary

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Accuracy validation of the designed and manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' for detection of SARS-CoV-2-specific T cells.

Detailed Description

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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.

Conditions

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SARS-CoV-2 Infection SARS-CoV-2 Vaccination

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Corona-T-test

Intervention Type DIAGNOSTIC_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

Corona-T-test

Intervention Type DIAGNOSTIC_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

Corona-T-test

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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


* 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)


* 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)


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal Research Institute of Pediatric Hematology, Oncology and Immunology

OTHER

Sponsor Role collaborator

DNKOM LLC

OTHER

Sponsor Role collaborator

National Research Center for Hematology, Russia

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grigory A Efimov, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National Research Center for Hematology

Locations

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National Research Center for Hematology

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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Corona-T-test

Identifier Type: -

Identifier Source: org_study_id