1. Systemic lupus erythematosus (SLE)
Conditions
Interventions
Influenza vaccination, followed by a second influenza vaccination in SLE patients after 4 weeks.
Sponsors
University Medical Center Groningen (UMCG)
P.O. Box 30001
9700 RB
Groningen
The Netherlands
+31 (0)50 3616161
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactA. Holvast
Department of Internal Medicine, Division of Clinical Immunology University Medical Center Groningen, University of Groningen PO Box 30.001
Outcome results
None listed