QuantiFERON-SARS-CoV-2: performance of an Interferon-Gamma Release Assay for COVID-19 before and after vaccination against SARS-CoV-2

Recruiting

• Conditions: corona; COVID-19; 10047438

• Registration Number: NL-OMON51150
• Lead Sponsor: Qiagen Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 950

Inclusion Criteria

Group 1:
- no known prior exposure to SARS-CoV-2 (based on PCR, antigen, antibody
testing)
- no signs and symptoms associated with COVID-19 in the 4 weeks prior to testing
- no vaccination against corona
Group 2:
- no known prior exposure to SARS-CoV-2 (preferably Group 1 participants)
- fully vaccinated against SARS-CoV-2 (last dose at least 14 days and maximally
24 weeks before testing)
Group 3:
- proven infection with SARS-CoV-2 14 days-24 weeks prior to testing
- no vaccination against corona
Group 4:
- Proven infection with SARS-CoV-2 14 days-16 weeks prior to testing (=Group 3
participants)
- Follow-up test 14 days-24 weeks after completion of vaccination

All groups: 18 year or older
Applicable consent has been given
Preferably willing and able to travel to Oss for testing

Exclusion Criteria

- Subject does meet the inclusion criteria.
- Groups 3 and 4 only: Subject has received convalescent plasma or monoclonal
antibodies as therapy for COVID-19
- Subject is a transplant recipient (solid organ or cell) or currently on any
treatment for cancer.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are<br /><br>(1) Corona-specific induction of IFN-&gamma; levels in blood cells of unexposed<br /><br>non-vaccinated subjects, measured by QFN-SARS (Group 1).<br /><br>(2) Corona-specific induction of IFN-&gamma; levels in blood cells of subjects<br /><br>without prior exposure to SARS-CoV-2, 14 days to 24 weeks after completion of<br /><br>vaccination (Group 2).<br /><br>(3) Antibodies against SARS-CoV-2 before and after vaccination<br /><br><br /><br>The study parameters will allow determination of specificity and sensitivity of<br /><br>QuantiFERON SARS-CoV-2 during vaccination. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(3) IFN-&gamma; levels in subjects with prior exposure to SARS-CoV-2 before (Group 3)<br /><br>and after vaccination (Group 4). </p><br>