Hôpital Bichat
Paris, 75018, France
Location status: Recruiting
NCT Number: NCT07047053
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, 75018, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at 3 and/or 6 month
Time frame: at 3 and/or 6 month
Time frame: before vaccination, at 3 and/or 6 month
Time frame: at 3 and/or 6 month
occurrence of non-serious adverse events
Time frame: at 3 and/or 6 month
occurrence of serious adverse events
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.
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: ZONAMID
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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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