Analysis of VZV immunisations on blood immune cells in patients with systemic lupus erythematodes

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031176

Enrollment

Registered

2023-02-01

Start date

2023-02-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination against Varizella Zoster M32

Interventions

Group 1: SLE patients using Belimumab Group 2: SLE patients using cDMARDs Group 3: SLE patients using anti malarials (Chloroquin, Hydroxychloroquin)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: diagnosed SLE (ACR-criteria), a vaccination against Varizella Zoster ist planned

Exclusion criteria

Exclusion criteria: malignant diseases

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 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 3) Qualitative response: Significant difference in quality of produced Anti-VZV-gE-antibodies as measured by glycosylation at day 28 after secondary vaccination.	—

Measure

Time frame

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. 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 3) Qualitative response: Significant difference in quality of produced Anti-VZV-gE-antibodies as measured by glycosylation at day 28 after secondary vaccination.

—

Countries

Germany

Contacts

Public ContactUlf Geisen

Universitätsklinikum Schleswig-Holstein Campus Kiel

ugeisen@rheuma.uni-kiel.de+49 431 500 22253

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026