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

NCT05165719 | Completed

• 1 other identifier: Corona-T-test
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The result of Corona-T-test

  positive, negative, or inconclusive (gray-zone)

  1 week

Study Arms (3)

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

Convalescents

PCR (polymerase chain reaction) confirmed COVID-19 in a period 14-45 days before recruitment

Diagnostic Test: Corona-T-test

Healthy donors

No self-reported COVID-19 infection

Diagnostic Test: Corona-T-test

Interventions

Corona-T-test 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; Healthy donors; Vaccinated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• \- Age under 18 y.o.

Sponsors & Collaborators

• National Research Center for Hematology, Russia: lead
• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: collaborator
• DNKOM LLC: collaborator

Study Sites (1)

National Research Center for Hematology

Moscow, 125167, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

frozen blood

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Grigory A Efimov, MD PhD

  National Research Center for Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: July 7, 2021
• Primary Completion: September 21, 2021
• Study Completion: November 20, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)