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

QuantiFERON-SARS-CoV-2: performance of an Interferon-Gamma Release Assay for COVID-19 before and after vaccination against SARS-CoV-2 - QFN-SARS: T cell responses pre- and post-vaccination

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51150

Enrollment

950

Registered

2021-06-15

Start date

2021-06-23

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

corona COVID-19

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The main study parameters are (1) Corona-specific induction of IFN-γ levels in blood cells of unexposed non-vaccinated subjects, measured by QFN-SARS (Group 1). (2) Corona-specific induction of IFN-γ levels in blood cells of subjects without prior exposure to SARS-CoV-2, 14 days to 24 weeks after completion of vaccination (Group 2). (3) Antibodies against SARS-CoV-2 before and after vaccination The study parameters will allow determination of specificity and sensitivity of QuantiFERON SARS-CoV-2 during vaccination.	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
(3) IFN-γ levels in subjects with prior exposure to SARS-CoV-2 before (Group 3) and after vaccination (Group 4).	—

Countries

Netherlands

Outcome results