The study is intended to determine the performance of a QuantiFERON SARS-CoV-2 test that QIAGEN will bring to the diagnostic market. The proposed study will contribute to establishing the diagnostic parameters such as specificity, sensitivity and…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
(3) IFN-γ levels in subjects with prior exposure to SARS-CoV-2 before (Group 3)
and after vaccination (Group 4).
Background summary
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) induces a strong
immune response leading to activation of B and T cells. In the field of
COVID-19 diagnostics, the B cell response is routinely monitored by measuring
antibodies against the nucleocapsid protein (NP), the spike protein (S1) or the
receptor-binding domain of the spike protein (RBD). In addition to binding
antibodies, neutralizing antibodies are measured in classical virus
neutralization tests and, more recently, surrogate virus neutralization tests,
such as cPass* (GenScript).
Protection against a new infection, however, is only partly conveyed by
antibodies. T cell-mediated responses are important in overcoming infection. In
addition, the T cell memory response is essential for long-term protection.
QIAGEN is the world-leader in the field of measuring T cell responses against
pathogens, with QuantiFERON-TB, an interferon-gamma-release-assay (IGRA) being
a broadly used IVD-test for the detection of (latent) tuberculosis (4). QIAGEN
has developed a QuantiFERON SARS-CoV-2 test which is currently available for
research use.
Study objective
The study is intended to determine the performance of a QuantiFERON SARS-CoV-2
test that QIAGEN will bring to the diagnostic market. The proposed study will
contribute to establishing the diagnostic parameters such as specificity,
sensitivity and positive and negative predictive value. The study will
demonstrate how well the test performs in subjects that have not been exposed
to SARS-CoV-2 and are subsequently vaccinated. In addition, the study will
explore the same parameters in subjects with a prior infection.
Study design
This is an observational study with 4 defined groups: Group 1 consists of
non-vaccinated subjects without prior exposure to SARS-CoV-2; Group 2 consists
of non-exposed, vaccinated subjects (14 days - 24 weeks after completion of
vaccination); Group 3 consists of non-vaccinated subjects with a prior natural
exposure and Group 4 consists of Group 3 participants after vaccination (14
days - 24 weeks after completion of vaccination).
Study burden and risks
The burden to participants consists of 2 visits to a blood collection site,
preceded by completion of a short questionnaire on the subject*s clinical
history of SARS-CoV-2 infection and vaccination status. Each visit consists of
a routine venepuncture during which max 20 mL blood will be collected. Visits
can be up to 4 months apart depending on the time of vaccination and the
specific vaccination schedule in the Netherlands. Tests performed will be
limited to measuring antibodies against SARS-CoV-2 and the IGRA test. Subjects
will be recruited in the Oss region, thus reducing the burden of travel.
Germantownroad 19300
Germantown MD 20874
US
Germantownroad 19300
Germantown MD 20874
US
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77844.028.21 |