Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

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.

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.

Eligibility

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

Study details
    Vaccination Varicella-zoster Virus
    Immune-mediated Systemic Inflammatory Diseases

NCT07047053

Assistance Publique - Hôpitaux de Paris

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.