Immunogenicity of a recombinant zoster vaccine (RZV) against herpes zoster (HZ) in adults with rheumatic diseases (SECTORED)
- Conditions
- - rheumatoid arthritis- axial spondyloarthritis- giant cell arteritisM05M05.3M05.8M05.9M06.0M06.8M06.9M45.0M31.5
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Male and female patients aged 18 years and older who are at increased risk to develop HZ
- Diagnosis of an RA, axSpA or GCA
- Stable, flare-free disease status within the last 6 month prior to enrollment.
- Shingrix zoster vaccination planned in routine care based on approval of Shingrix
Exclusion Criteria
- Pregnancy
- Episode of zoster in the past 6 months
- Inability to give consent
- Previous live vaccination against shingles
- VZV vaccination within 12 months prior to start of the study
- Contraindications to vaccination: Allergies to components of the vaccine. Undesirable drug reactions in the temporal connection with the vaccination are also a contraindication against a repeated vaccination with the same vaccine until the cause is clarified.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is set as the number of patients with a cell-mediated vaccine response measured by gE-specific T cells against RZV (= CMI) at month 12 post FDV.
- Secondary Outcome Measures
Name Time Method 1.) cell-mediated vaccine response measured by gE-specific T cells against RZV (= CMI) at month 3 post FDV<br>2.) Number of gE-specific T cells at 0, 3 and 12 months post FDV<br>3.) Anti-gE IgG titer at 0, 3, 6 and 12 months post FDV<br>4.) Number, intensity and duration of injection site reactions at each follow-up visit<br>5.) Number, intensity and duration of systemic reactions, AESI, occurrence of HZ and/or HZ complications at each follow-up visit<br>6.) Number of flares at each follow-up visit