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 - The Shingr'HIV Phase IV Multicenter Study

2022-01314

The purpose of this study is to evaluate the efficacy and safety of the adjuvanted recombinant Zoster vaccine (RZV, or Shingrix®) in older people (\> 50 years) living with HIV (PLWH) compared to age-matched healthy adults over a 1-year period.

2022-12-14

2024-09-30

2025-09-30

Recruiting

Early phase I

225

Inclusion Criteria: For PLWH: * Be registered in the SHCS or in the ANRS CO3 Aquitaine Cohort * Age \>50 YOA * Time since cART initiation \> 10 years * Not already vaccinated with RZV * HIV viral load \<50 copies/ml (within 6 months from the last blood sampling) * Informed consent as documented by signature * (France) : Person affiliated with or beneficiary of the French social security scheme For aged/gender-matched controls * Age \>50 YOA * Not already vaccinated with RZV * Informed consent as documented by signature * (France) Not HIV infected * (France) Person affiliated with or beneficiary of the French social security scheme Exclusion Criteria: * Ongoing signs of febrile or non-febrile infection at the time of the first vaccination * 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 \[an equivalent dose of prednisolone \>20 mg/day \> 3 months\], monoclonal antibodies, cytostatics, biological products, etc.) within 6 months before screening. * Administration of immunoglobulins or any blood products within 3 months preceding the first dose of vaccine or planned administration during the study period * 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 * 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 * Participation in another study with investigational drug within the 30 days preceding and during the present study. * (France) Pregnant or breastfeeding woman * (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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 225, 'type': 'ESTIMATED'}}

2023-11-08