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NCT Number: NCT07047053

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Bichat

Paris, 75018, France

Location status: Recruiting

Location contact

Tiphaine Goulenok, MD

CONTACT

[email protected]

0140257289 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Levels of antibodies specific to VZV gE glycoprotein and levels of specific T lymphocytes after stimulation with peptides contained in the vaccine (in SFC/106 PBMC)

    Time frame: at 3 and/or 6 month

  2. level of antibodies specific to the VZV gE glycoprotein after stimulation with peptides contained in the vaccine (in SFC/106 PBMC)

    Time frame: at 3 and/or 6 month

Secondary outcomes

  1. Frequency of specific T cells

    Time frame: before vaccination, at 3 and/or 6 month

  2. Tolerance of the VZV vaccine

    Time frame: at 3 and/or 6 month

    occurrence of non-serious adverse events

  3. Safety of the VZV vaccine

    Time frame: at 3 and/or 6 month

    occurrence of serious adverse events

  4. measuring change in IMID (Immune mediated inflammatory disease) activity. The data collected will be aggregated into a composite score.

    Time frame: at 3 and/or 6 month

    The measures used depend on the scale specific to each IMID. The parameters collected will be the scales (SLEDAI for SLE, ESSDAI for Sjögren's syndrome, mRSS for systemic sclerosis, BSAS for Behcet's disease and BVAS for vasculitis), the physiological parameters collected by the referring doctor and, where appropriate, certain biological activity parameters (C-reactive protein, anti-DNA, ANCA, etc.). The data collected will be aggregated into a composite score.

Study contacts

Contact information is provided by the study sponsor or research team.

Tiphaine Goulenok, MD

CONTACT

[email protected]

0140257289 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ZONAMID

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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