NCT07047053 Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting
| NCT ID | NCT07047053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Vaccination Varicella-zoster Virus |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-06-10 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07047053 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vaccination Varicella-zoster Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07047053 currently recruiting?
Yes, NCT07047053 is actively recruiting participants. Contact the research team at tiphaine.goulenok@aphp.fr for enrollment information.
Where is the NCT07047053 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07047053 clinical trial?
NCT07047053 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 50 participants.