|- candidate number||2894|
|- NTR Number||NTR1147|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-nov-2007|
|- Secondary IDs||2007/172 Medical Ethics Committee University Medical Center Groningen|
|- Public Title||Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?|
|- Scientific Title||Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Systemic lupus erythematosus (SLE)|
|- Inclusion criteria||Patients:|
1. patients have to fulfil international disease criteria of SLE;
2. quiescent disease, defined as SLEDAI ¡Ü5;
3. informed consent;
1. informed consent.
|- Exclusion criteria||Patients:|
1. active disease, defined as SLEDAI >5;
2. use of prednisone >30 mg/day;
5. no informed consent.
1. use of immunosuppressives;
4. no informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||27-sep-2007|
|- planned closingdate||1-mrt-2008|
|- Target number of participants||82|
|- Interventions||Influenza vaccination, followed by a second influenza vaccination in SLE patients after 4 weeks.|
|- Primary outcome||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.|
|- Secondary outcome||Within SLE patients:|
1. Seroconversions and fourfold titre rises at t = 8 weeks versus at t = 4 weeks;
2. Geometric mean titres at t = 8 weeks versus at t = 4 weeks.
Between SLE patients and healthy controls:
1. Seroprotection rate in SLE patients at t = 4 weeks versus seroprotection rate in healthy controls at t = 4 weeks;
2. Seroprotection rate in SLE patients at t = 8 weeks versus seroprotection rate in healthy controls at t = 4 weeks.
|- Timepoints||1. inclusion, t = 0;|
2. t = 4 weeks;
3. t = 8 weeks (only for SLE patients).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| A. Holvast|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Marc Bijl|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Solvay Pharmaceuticals GMBH|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||19-nov-2007 - 4-jun-2008|