Идёт набор NCT07047053

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

— Наблюдательное Vaccination Varicella-zoster Virus Immune-mediated Systemic Inflammatory Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Vaccination Varicella-zoster Virus, Immune-mediated Systemic Inflammatory Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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) [Срок оценки: at 3 and/or 6 month]
level of antibodies specific to the VZV gE glycoprotein after stimulation with peptides contained in the vaccine (in SFC/106 PBMC) [Срок оценки: at 3 and/or 6 month]

Вторичные конечные точки (4)

Frequency of specific T cells [Срок оценки: before vaccination, at 3 and/or 6 month]
Tolerance of the VZV vaccine [Срок оценки: at 3 and/or 6 month]
Safety of the VZV vaccine [Срок оценки: at 3 and/or 6 month]
measuring change in IMID (Immune mediated inflammatory disease) activity. The data collected will be aggregated into a composite score. [Срок оценки: at 3 and/or 6 month]

Критерии участия

Критерии включения

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)