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

Completed

• Conditions: SARS-CoV-2 Vaccination; SARS-CoV-2 Infection
• Interventions: Diagnostic Test: Corona-T-test

• Registration Number: NCT05165719
• Lead Sponsor: National Research Center for Hematology, Russia

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.

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 Timeline

• Study Start: 2021-07-07
• Primary Completion: 2021-09-21
• Study Completion: 2021-11-20
• Status Verified: 2021-12
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-17
• Last Update Submitted: 2021-12-17
• Study First Posted: 2021-12-21
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinated	Corona-T-test	SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment
Convalescents	Corona-T-test	PCR (polymerase chain reaction) confirmed COVID-19 in a period 14-45 days before recruitment
Healthy donors	Corona-T-test	No self-reported COVID-19 infection

Primary Outcome Measures

Name	Time	Method
The result of Corona-T-test	1 week	positive, negative, or inconclusive (gray-zone)

Trial Locations

Locations (1)

National Research Center for Hematology; 🇷🇺 Moscow, Russian Federation