Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Vaccination Varicella-zoster Virus, Immune-mediated Systemic Inflammatory Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Vaccination with the recombinant anti-VZV vaccine (Shingrix) is carried out as part of treatment in all immunocompromised patients over 18 years of age, in accordance with HAS recommendations (the vaccination schedule requires 2 doses 2 months apart).
The vaccine response will be measured during hospitalisation and/or follow-up consultations, using the same sample as that used to monitor MIMI in the same laboratory (Immunology Laboratory, CHU Bichat).
Clinical and biological data will be collected to study factors associated with vaccine response, vaccine tolerance and MIMI activity.
Information relating to diagnosis, examinations and follow-up will be collated in the patient's medical file.
Patients are systematically seen every 6 months for follow-up consultations as part of their MIMI.
No additional visits are planned for research purposes.
Primary outcome measures
- Levels of antibodies specific to VZV gE glycoprotein and levels of specific T lymphocytes after stimulation with peptides contained in the vaccine (in SFC/106 PBMC) [Time frame: at 3 and/or 6 month]
- level of antibodies specific to the VZV gE glycoprotein after stimulation with peptides contained in the vaccine (in SFC/106 PBMC) [Time frame: at 3 and/or 6 month]
Secondary outcome measures (4)
- Frequency of specific T cells [Time frame: before vaccination, at 3 and/or 6 month]
- Tolerance of the VZV vaccine [Time frame: at 3 and/or 6 month]
- Safety of the VZV vaccine [Time frame: at 3 and/or 6 month]
- measuring change in IMID (Immune mediated inflammatory disease) activity. The data collected will be aggregated into a composite score. [Time frame: at 3 and/or 6 month]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Bichat — Paris
Identifiers
NCT: NCT07047053 · APHP250443 · 2025-A00547-42