Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting
NCT ID: NCT07047053
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-06-10
2027-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with immune-mediated systemic inflammatory diseases (IMID)
All patients treated for IMID in the internal medicine department of Hôpital Bichat, vaccinated against VZV as part of their care, in accordance with HAS recommendations.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Hôpital Bichat
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A00547-42
Identifier Type: OTHER
Identifier Source: secondary_id
APHP250443
Identifier Type: -
Identifier Source: org_study_id
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