How well the shingles vaccine works for adults with immune-mediated systemic inflammatory diseases
Evaluation of the Anti-VZV Vaccine Response of Patients With Immune-mediated Systemic Inflammatory Diseases Vaccinated in the Care Setting
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 type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT07047053 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris
- Hôpital Bichat — Paris, France (Recruiting)
Study contacts
- Study coordinator: Tiphaine Goulenok, MD
- Email: tiphaine.goulenok@aphp.fr
- Phone: 0140257289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.