Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?
Completed
- Conditions
- 1. Systemic lupus erythematosus (SLE)<br />2. influenza vaccination<br />3. booster<br />4. antibody response.
- Registration Number
- NL-OMON20800
- Lead Sponsor
- niversity Medical Center Groningen (UMCG)P.O. Box 300019700 RBGroningenThe Netherlands+31 (0)50 3616161
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 82
Inclusion Criteria
Patients:
1. patients have to fulfil international disease criteria of SLE;
Exclusion Criteria
Patients:
1. active disease, defined as SLEDAI >5;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Within SLE patients:<br /><br>1. Seroconversions and fourfold titre rises at t = 8 weeks versus at t = 4 weeks;<br /><br>2. Geometric mean titres at t = 8 weeks versus at t = 4 weeks.<br /> <br><br /><br /><br>Between SLE patients and healthy controls:<br /><br>1. Seroprotection rate in SLE patients at t = 4 weeks versus seroprotection rate in healthy controls at t = 4 weeks;<br /><br>2. Seroprotection rate in SLE patients at t = 8 weeks versus seroprotection rate in healthy controls at t = 4 weeks.