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Q-koorts post-vaccination study.


- candidate number9827
- NTR NumberNTR2953
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2011
- Secondary IDsNL36319 CCMO
- Public TitleQ-koorts post-vaccination study.
- Scientific TitleQ-koorts post-vaccination study.
- ACRONYM
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedQ-fever infection, Post-vaccination, Humoral immune response, Cellular immune response
- Inclusion criteria1. Has taken part in the national Q-fever vaccination program;
2. Willing to adhere to blood draw schedule;
3. Signed Informed Consent.
- Exclusion criteriaNone.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2011
- planned closingdate1-jul-2012
- Target number of participants280
- InterventionsN/A
- Primary outcomeHumoral 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 outcomeN/A
- Timepoints4, 8, and 12 months after vaccination (vaccination program took place prior to this study).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.A.J. Boxtel, van
- CONTACT for SCIENTIFIC QUERIESDr. H.A. Bijlmer
- Sponsor/Initiator Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD24-jun-2011 - 30-aug-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl