Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?
Completed
- Conditions
- systemische lupus erythematosuslupus10003816
- Registration Number
- NL-OMON31124
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 82
Inclusion Criteria
Patients
- patients have to fulfil international disease criteria of SLE
- quiescent disease, defined as SLEDAI <=5
- informed consent;Healthy controls
- informed consent
Exclusion Criteria
Patients
- active disease, defined as SLEDAI >5
- use of prednisone >30 mg/day
- pregnancy
- malignancy
- no informed consent;Healthy controls
- use of immunosuppressives
- malignancy
- pregnancy
- no informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Seroprotection rate (the percentage of SLE patients with a titre equal to or<br /><br>greater than 40 against all three vaccine strains) in SLE patients after two<br /><br>influenza vaccinations as compared to a single vaccination.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Seroconversions and fourfold titre rises after 4 weeks and after 8 weeks.<br /><br>2. Geometric mean titres after four weeks and after 8 weeks</p><br>