NCT07047053

Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Vaccination Varicella-zoster Virus
• Immune-mediated Systemic Inflammatory Diseases

Timeline

• Start date: 2025-06-10
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2025-07-02
• Last updated: 2025-07-02

Locations

1 site across 1 country: France