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Influenza vaccination in patients with systemic lupus erythematosus and Wegener's granulomatosis.


- candidate number2882
- NTR NumberNTR1130
- ISRCTNWordt niet aangevraagd/retrospectief onderzoek
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-nov-2007
- Secondary IDs2005-147 Medical Ethics Committee - University Medical Center Groningen
- Public TitleInfluenza vaccination in patients with systemic lupus erythematosus and Wegener's granulomatosis.
- Scientific TitleInfluenza vaccination in patients with systemic lupus erythematosus and Wegener's granulomatosis.
- ACRONYMN/A
- hypothesis1. a. Does influenza vaccination in SLE and Wegener patients result in a decreased humoral immune response compared to healthy age-matched controls?;
b. Does influenza vaccination in SLE and Wegener patients result in a decreased cellular immune respons compared to healthy age-matched controls?;
c. Do different immuno-suppressive therapies in these patients influence the immune responses after vaccination?;
2. Does influenza vaccination in SLE and Wegener patients increase disease activity?
- Healt Condition(s) or Problem(s) studiedSystemic lupus erythematosus (SLE), Wegener's granulomatosis
- Inclusion criteria1. Patients have to fulfil international disease criteria of SLE or WG;
2. quiescent disease, defined as SLEDAI under 6 or BVAS under 2;
3. informed consent.
- Exclusion criteriaSLE patients are not eligible for the study in case of:
1. active disease, defined as SLEDAI >5;
2. a yearly influenza vaccination is concerned mandatory by the patient's physician;
3. use of prednisone >30 mg/day;
4. pregnancy;
5. no informed consent.


WG patients are not eligible for the study in case of:
1. active disease, defined as BVAS >1;
2. a yearly influenza vaccination is concerned mandatory by the patient's physician;
3. use of prednisone >30 mg/day;
4. use of cyclofosfamide >100 mg/day;
5. pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2005
- planned closingdate1-mei-2006
- Target number of participants240
- InterventionsInfluenza vaccination.
- Primary outcomeAntibody response to vaccination:
seroprotection rate, fourfold titre rises and geometric mean titres.
- Secondary outcome1. safety: changes in disease activity in terms of SLEDAI (systemic lupus erythematosus) or BVAS (Wegener's granulomatosis). 2. Effect of immunosuppressive drugs on antibody responses to vaccination 3. cell-mediated responses to influenza (vaccination)
- Timepointst = 0
t = 1 month
t = 3-4 months
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES A. Holvast
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Marc Bijl
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Solvay Pharmaceuticals GMBH, J.k. de Cock Foundation
- PublicationsAnn Rheum Dis. 2008 Jul 14. [Epub ahead of print].
- Brief summaryInfluenza vaccination in patients with systemic lupus erythematosus (SLE) and Wegener's granulomatosis (WG) seems indicated, as they are at increased risk for infections and have a higher risk of morbidity and mortality following influenza infection. However, questions regarding safety and efficacy of vaccination remain.


In this study we will address the questions concerning safety and immunogenicity of influenza vaccination in our (immuno-suppressed) cohorts of SLE and WG patients. Patients with different immuno-suppressive regimes will be vaccinated and disease activity and antibody response will be monitored thereafter.


Patients will be randomized to receive either a vaccination or to participate as patient control. Furthermore a group of healthy controls will be vaccinated. Follow-up will be at 1 month and 3-4 months following vaccination.


Primary outcomes is the antibody response to vaccination, secondary outcomes are disease activity as measured by disease activity indexes and cell-mediated immune responses to influenza.
- Main changes (audit trail)
- RECORD14-nov-2007 - 11-nov-2008


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