Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 1, 2025
Trial Information
Current as of July 05, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well a shingles vaccine works in people who have certain immune system-related inflammatory diseases, like lupus, scleroderma, or vasculitis. These patients often take medications that weaken their immune system, which puts them at higher risk for shingles. The researchers want to see if the recommended vaccine helps these patients develop protection against the virus that causes shingles.
People eligible for this study are adults over 18 who are being treated for one of these immune diseases and who either need the vaccine because of their weakened immune system or because they are over 65 years old. Participants will have already received at least one dose of the vaccine between June 2025 and June 2026. The study is open to all genders, but people with cancer, previous shingles vaccination, pregnancy, or certain legal or health restrictions are not eligible. Participants can expect to have blood tests to check their immune response after vaccination, and their care will continue as usual throughout the study. This research is important because it will help doctors understand how well the vaccine protects people whose immune systems may not respond as strongly.
Gender
ALL
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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported