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

SARS-CoV-2 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05165719
• Other study ID #: Corona-T-test
• Status: Completed
• Start date: July 7, 2021
• Est. completion date: November 20, 2021

Study information

• Verified date: December 2021
• Source: National Research Center for Hematology, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: November 20, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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-Ig?-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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Diagnostic Test:
• Corona-T-test
Corona-T-test - a single-color enzymatic ELISpot kit for the detection of interferon-gamma (IFN?), produced by the National Research Center for Hematology aiming detection of SARS-CoV-2-specific T cells

Locations

Country	Name	City	State
Russian Federation	National Research Center for Hematology	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
National Research Center for Hematology, Russia	DNKOM LLC, Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The result of Corona-T-test	positive, negative, or inconclusive (gray-zone)	1 week