The objective of the current study is to evaluate the performance of two new formats of the IGRA using pre-filled antigen formulations in a cohort of Dutch individuals with known prior exposure to Cb.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Background-corrected Cb-specific IFNgamma production in the different test
formats, and percentage of IGRA+ individuals in the different test formats
based on pre-established cut-offs.
Secondary outcome
Background-corrected Cb-specific production of mediators induced down-stream of
IFNgamma.
Background summary
The highly infectious coccobacillus Coxiella burnetii (Cb) is the causative
agent of both acute and chronic Q fever disease in humans. Vaccination using an
inactivated whole cell vaccine requires screening for prior exposure to Cb to
mitigate adverse reactions to vaccination, but the combination of current
pre-screening measures (serology and skin-prick test) is time consuming and
insufficiently sensitive. Prior studies indicate that cytokine release by
circulating immune cells in response to heat-killed whole cell Cb antigen
(IFNgamma release assay, IGRA) is a more sensitive tool to assess pre-existing
immune responses to Cb. To improve the usability of the current IGRA in
high-volume central laboratory settings and in remote/resource austere
settings, two new formats using pre-filled antigen formulations in microtubes
(stage 1 adaptation) and cartridges for stimulation directly at the point of
blood collection (stage 2 adaptation) are being developed.
Study objective
The objective of the current study is to evaluate the performance of two new
formats of the IGRA using pre-filled antigen formulations in a cohort of Dutch
individuals with known prior exposure to Cb.
Study design
Hundred-forty subjects with known exposure history and clinical Q fever status
will be recruited for this single site observational study. All subjects will
be asked to donate blood at least three, but no more than five times for the
separate evaluation of each of the two new IGRA assay formats (all subjects)
and the assessment of parameters such as batch-to-batch and run-to-run
reproducibility and storage stability of the pre-filled antigen formulations
(in subgroups of up to 10 individuals each).
Study burden and risks
Venipunctures are performed by trained phlebotomists and pose a negligible
risk. Participation will require three to five visits of max. 20 minutes.
Fruit Street 55
Boston MA 02114-2621
US
Fruit Street 55
Boston MA 02114-2621
US
Listed location countries
Age
Inclusion criteria
- At least 18 years old;
- Able and willing to sign the informed consent form;
- Coxiella IGRA testing previously performed at Innatoss as part of research or
diagnostic activities
Exclusion criteria
There are no specific criteria for subjects to be excluded from participation
in this study.
Design
Recruitment
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 | NL74801.028.20 |