1. Systemic lupus erythematosus
Conditions
Interventions
Sponsors
University Medical Center Groningen, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 criteria
Exclusion criteria: SLE 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody response to vaccination: seroprotection rate, fourfold titre rises and geometric mean titres. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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) | — |
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