No registrations found.
ID
Source
Brief title
Health condition
1. Systemic lupus erythematosus (SLE);
2. influenza vaccination;
3. booster;
4. antibody response.
Sponsors and support
P.O. Box 30001
9700 RB
Groningen
The Netherlands
+31 (0)50 3616161
Weesp, the Netherlands
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
1. inclusion, t = 0;
2. t = 4 weeks;
3. t = 8 weeks (only for SLE patients).
Intervention
Influenza vaccination, followed by a second influenza vaccination in SLE patients after 4 weeks.
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
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
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1112 |
| NTR-old | NTR1147 |
| Other | Medical Ethics Committee University Medical Center Groningen : 2007/172 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |