Analysis of VZV immunisations on blood immune cells in patients with systemic lupus erythematodes
Recruiting
- Conditions
- Vaccination against Varizella ZosterM32Systemic lupus erythematosus
- Registration Number
- DRKS00031176
- Lead Sponsor
- niversitätsklinikum Schleswig-Holstein Campus Kiel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
diagnosed SLE (ACR-criteria), a vaccination against Varizella Zoster ist planned
Exclusion Criteria
malignant diseases
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome will be the clinical effect of the vaccination on disease activity in patients with SLE as measured by SLEDAI after the vaccinations 1 and 2 (day 28 after according vaccination) measured as a change in SLEDAI of no less than 5 points.
- Secondary Outcome Measures
Name Time Method 1)Serological response: Significant increase of VZV-gE specific antibody titers and plasma cells 7 days after the second immunization as compared to baseline and study data at day 28 after second immunization. <br>2)Cellular response: significant increase of protective (Anti-VZV-gE) and autoreactive (Anti-dsDNA) T and B cells in patients as compared to baseline and study data from healthy controls (phase 3 study data) and significant difference in migratory function at day 28 after secondary immunization<br>3)Qualitative response: Significant difference in quality of produced Anti-VZV-gE-antibodies as measured by glycosylation at day 28 after secondary vaccination.<br>