To gain insight in the humoral and cellular immune response of people with risk factors for chronic Q-fever after vaccination against Q-fever and of people who have had a natural infection or have a chronic infection.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Humoral immune response: IgG and IgM antibodies against fase 1 and 2 antigens
of C. burnetii are measured by means of several serological tests:: immune
fluorescence assay (IFA), enzyme-linked immuno sorbent assay (ELISA),
complement binding reaction (CBR), polymerase chain reaction (PCR) and
micro-array.
Cellular immune response:
After stimulation of whole blood, the levels of interferon-gamma (IFN-gamma),
interleukine (IL)-10 and possibly IL-12 production are measured. Also a
T-helper 1 and T-helper 2 cytokine profile are measured in isolated mononuclear
cells, isolated CD14+ monocytes and isolated T-cells after stimulation, and
differentiation of the cells is studied.
Secondary outcome
not applicable
Background summary
Currently a Q-fever vaccination campaign is ongoing in The Netherlands for
people with an increased risk of a serious course or the chronic form of
Q-fever after infection with Coxiella burnetii. The risk factors are some
vascular disorders and heart valve disorders. The gevaccinated population in
The Netherlands is unique in the world; the Q-fever vaccine is used in
Australia in youngm helathy people without prior exposure to C. burnetii. In a
population with the mentioned risk the humoral or cellular immune responses are
unknown. Besides that it is unknown whether there are in the immune responses
between vaccinated people and those who have had a natural infection.
Study objective
To gain insight in the humoral and cellular immune response of people with risk
factors for chronic Q-fever after vaccination against Q-fever and of people who
have had a natural infection or have a chronic infection.
Study design
Observational study without intervention with invasive measurements (2 blood
draws). Three blood tubes (30 ml) will be drawn at 6 months and 12 months after
vaccination (or after a positive result of serological screening of skin test)
and a short questionnaire will be answered. The blood draw will be combined
with a regular visit at the outpatient clinic of the participant. If this is
not possible within 3 weeks prior to or after the planned date, the blood
drawal will be done at the participant's home.
Study burden and risks
The burden for the participants of this study is judged as low. The potential
risks of venapunction is possibly local pain or a haematoma and is considered
negligible.
postbus 1
3720 BA
NL
postbus 1
3720 BA
NL
Listed location countries
Age
Inclusion criteria
- Signed Informed Consent
- willing to adhere to blood draw schedule
- has taken part in the national Q-fever vaccination campaign
Exclusion criteria
none
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-001401-28-NL |
| CCMO | NL36319.000.11 |
| OMON | NL-OMON28463 |