SLE patients show a decreased humoral immune response to influenza vaccination, as compared to healthy controls. Furthermore the use of immunosuppressives is of influence on vaccination immunogenicity, it has been demonstrated that the use of drugs…
ID
Bron
Verkorte titel
Aandoening
1. Systemic lupus erythematosus (SLE);
2. influenza vaccination;
3. booster;
4. antibody response.
Ondersteuning
P.O. Box 30001
9700 RB
Groningen
The Netherlands
+31 (0)50 3616161
Weesp, the Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Seroprotection rate (the percentage of SLE patients with a titre equal to or greater than 40 against all three vaccine strains) in SLE patients after two influenza vaccinations as compared to a single vaccination.
Achtergrond van het onderzoek
Systemic lupus erythematosus (SLE) is an autoimmune disease, patients are often treated with immunosuppressive drugs to control disease activity. This causes patients to be susceptible for infections, like influenza. Former research showed influenza vaccination to be safe in SLE, however fewer patients reached protective titres as compared to healthy controls. It is desirable to increase this seroprotection rate. A second, booster vaccination, administered 4 weeks after the first vaccination is a possible approach to achief a higher seroprotection rate.
In this study, it will be assessed whether a second, booster, influenza vaccination leads to a higher seroprotection rate in SLE patients, as compared to a single vaccination.
Doel van het onderzoek
SLE patients show a decreased humoral immune response to influenza vaccination, as compared to healthy controls. Furthermore the use of immunosuppressives is of influence on vaccination immunogenicity, it has been demonstrated that the use of drugs like corticosteroids, azathioprine, and cyclosporin hampers the humoral immune response, reflected by a decreased antibody response after vaccination.
In liver transplant recipients a decreased humoral immune response to influenza vaccination was found as well. A second, booster, influenza vaccination improved the humoral immune response.
In this study we will investigate whether a second, booster, influenza vaccination improves the immune response in SLE patients with quiescent disease. Patients with different immunosuppressive regimes will be vaccinated and disease activity and antibody response will be monitored thereafter.
Onderzoeksopzet
1. inclusion, t = 0;
2. t = 4 weeks;
3. t = 8 weeks (only for SLE patients).
Onderzoeksproduct en/of interventie
Influenza vaccination, followed by a second influenza vaccination in SLE patients after 4 weeks.
Publiek
University Medical Center Groningen, University of Groningen
PO Box 30.001
A. Holvast
Groningen 9700 RB
The Netherlands
31) 50-3612945,
B.Holvast@int.umcg.nl
Wetenschappelijk
University Medical Center Groningen, University of Groningen
PO Box 30.001
A. Holvast
Groningen 9700 RB
The Netherlands
31) 50-3612945,
B.Holvast@int.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients:
1. patients have to fulfil international disease criteria of SLE;
2. quiescent disease, defined as SLEDAI ¡Ü5;
3. informed consent;
Healthy controls:
1. informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients:
1. active disease, defined as SLEDAI >5;
2. use of prednisone >30 mg/day;
3. pregnancy;
4. malignancy;
5. no informed consent.
Healthy controls:
1. use of immunosuppressives;
2. malignancy;
3. pregnancy;
4. no informed consent.
Opzet
Deelname
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Register | ID |
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NTR-new | NL1112 |
NTR-old | NTR1147 |
Ander register | Medical Ethics Committee University Medical Center Groningen : 2007/172 |
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