No registrations found.
ID
Source
Health condition
Q-fever infection;
post-vaccination;
humoral immune response;
cellular immune response.
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:
1. Immune fluorescence assay (IFA);
2. Enzyme-linked immuno sorbent assay (ELISA);
3. Complement binding reaction (CBR);
4. Polymerase chain reaction (PCR);
5. 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
N/A
Background summary
In The Netherlands, an unique population is vaccinated against Q-fever, namely people with risk factors for a complicated course of a Q-fever infection. In this study the humoral and cellular immune response is compared in 3 groups: vaccinated people, people screened for but not vaccinated due to serologic profile showing previous Q-fever infection, and people screened for but not vaccinated due to serologic profile showing a chronic Q-fever infection. The groups are also compared with a group of naturally infected people for which similar data have been already collected.
Study objective
To gain insight in the humoral and cellular immune response against Coxiella burnetii of people with risk factors for chronic Q-fever infection who are either vaccinated or have experienced a natural infection or have a chronic infection.
Study design
4, 8, and 12 months after vaccination (vaccination program took place prior to this study).
Intervention
N/A
R.A.J. Boxtel, van
Bilthoven 3721 MA
The Netherlands
+31 (0)30 2742755
renee.van.boxtel@rivm.nl
R.A.J. Boxtel, van
Bilthoven 3721 MA
The Netherlands
+31 (0)30 2742755
renee.van.boxtel@rivm.nl
Inclusion criteria
1. Has taken part in the national Q-fever vaccination program;
2. Willing to adhere to blood draw schedule;
3. Signed Informed Consent.
Exclusion criteria
None.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2812 |
| NTR-old | NTR2953 |
| CCMO | NL36319.000.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35763 |