Clinical trial Recruiting at 1 site Observational Ages 18 and up

How well the shingles vaccine works for adults with immune-mediated systemic inflammatory diseases

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

Run by Assistance Publique - Hôpitaux de Paris · NCT07047053 · Data updated 2026-11-12

This will test whether the recombinant shingles vaccine (Shingrix) produces an antibody response in adults with immune-mediated systemic inflammatory diseases who are on immunosuppressive therapy.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Paris)
StatusRecruiting
StartedJune 10, 2025
Main results expectedJanuary 2027
Study endsApril 2027
Registry record updatedJuly 2, 2025
Trial IDNCT07047053 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with listed immune-mediated systemic inflammatory diseases who are followed in the internal medicine department at Hôpital Bichat, received at least the first dose of the recombinant VZV vaccine between June 2025 and June 2026, and have a serum sample available for analysis.

Probably not a fit

Patients with evolving cancer are excluded, and some patients on strong immunosuppression may not mount a detectable antibody response and therefore may not derive protective benefit from vaccination.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study measures anti-VZV seroconversion after routine vaccination with the recombinant shingles vaccine given as two doses two months apart in adults with immune-mediated systemic inflammatory diseases followed at Hôpital Bichat. Antibody response will be measured using serum samples collected during standard hospitalizations or follow-up visits in the CHU Bichat immunology laboratory, with no extra study visits required. Clinical and biological data will be collected to identify factors linked to vaccine response, vaccine tolerance, and underlying disease activity. Eligible patients include those vaccinated between June 2025 and June 2026 who have at least one available serum sample and have received the first vaccine dose.

Why it matters

Potential benefit: If successful, the results could show how well Shingrix protects IMID patients and help guide timing or additional measures to improve protection for people on immunosuppression.

How similar studies have gone: Recombinant VZV vaccines have produced good immune responses in several other immunocompromised populations, but data specifically in many IMID patients on current immunosuppressive regimens remain limited.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Hôpital Bichat
    Paris, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.