Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting
Recruiting now
Conditions studied: Vaccination Varicella-zoster Virus, Immune-mediated Systemic Inflammatory Diseases
In brief
Patients with immune-mediated systemic inflammatory diseases (IMID) are at increased risk of shingles due to treatment-induced immunosuppression. In line with international recommendations, the French National Authority for Health (HAS) updated the varicella-zoster virus (VZV) vaccination strategy in March 2024. The HAS now recommends that immunocompromised people aged 18 and over be vaccinated with the recombinant VZV vaccine. However, due to the immunosuppressive treatment received, the vaccine response in MIMI patients is often suboptimal, and the protection induced by the herpes zoster vaccine in this context is unknown. The aim of our study is to determine the rate of anti-VZV seroconversion after vaccination with recombinant anti-VZV vaccine, in patients followed up for MIMI.
Key facts
- Study ID
- NCT07047053
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 50
- Starts
- 2025-06-10
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2025-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient over 18 years of age being managed for MIMI, including
- Systemic lupus
- Gougerot-Sjögren's syndrome
- Systemic scleroderma
- Mixed connectivitis
- Inflammatory myositis
- Systemic sarcoidosis
- Systemic vasculitis (necrotizing vasculitis and giant cell arteritis)
- Behçet's disease
- Adult Still's disease
- IgG4-associated disease
- Autoimmune cytopenias (autoimmune hemolytic anemia, immunological thrombocytopenic purpura, Evans syndrome)
- Susac syndrome
- Followed in the internal medicine department of Hôpital Bichat, Paris
- Justifying VZV vaccination due to immunosuppression or age over 65.
- Vaccinated as part of care between June 2025 and June 2026
- Regardless of history of shingles
- With a serum sample available for analysis
- Having received at least the first dose of the vaccine regimen (in hospital or in the community)
You may not qualify if…
- Evolving cancer, with or without treatment (chemotherapy, immunotherapy, etc.)
- History of VZV vaccination (live or recombinant)
- Patient who has had an allergic reaction to a vaccine
- Pregnancy
- Patient under legal protection, guardianship or trusteeship
- Not affiliated to a social security scheme (general or CMU)
- Patient unable to understand research information
- Absence of non-opposition
Where it is running
- Hôpital Bichat — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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