Immune response to the recombinant Zoster Vaccine in people living with HIV over 50 years of age compared to non-HIV age- and gender-matched controls - Shingr'HIV
- Conditions
- Human Immunodeficiency Virus (HIV)MedDRA version: 20.1Level: PTClassification code: 10020161Term: HIV infection Class: 100000004862Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-504482-23-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Bordeaux
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 225
For PLWH: Be registered in the SHCS or in the ANRS CO3 Aquitaine Cohort, For PLWH + Controls : Age >50 YOA, For PLWH: Time since cART initiation > 10 years, For PLWH + Controls : Not already vaccinated with RZV, For PLWH: HIV viral load <50 copies/ml (within 6 months from the last blood sampling), For PLWH + Controls : Informed consent as documented by signature, For PLWH + Controls : (France) : Person affiliated with or beneficiary of the French social security scheme
Ongoing signs of febrile or non-febrile infection at the time of the first vaccination, Participation in another study with investigational drug within the 30 days preceding and during the present study, Administration of immunoglobulins or any blood products within 3 months preceding the first dose of vaccine or planned administration during the study period, (France) Patient governed by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)., Immunosuppression from the following: Current malignant neoplasm; primary immunodeficiency; recent (<2 years) solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy; Intake of drugs which suppress the immune system (e.g. glucocorticoids for a long time [an equivalent dose of prednisone >20 mg/day > 3 months], monoclonal antibodies, cytostatics, biological products, etc.) within 6 months before screening, Having received a vaccine in the last month or is expected to receive a vaccine in the next month, Having received a shingles vaccine within one year, Presented with herpes zoster in the previous year, Contra-indication to RZV due to hypersensitivity to the active substances or to any of the excipients, Hospitalized patients, Unable to provide informed consent or inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method