RZV Vaccine (Shingrix ®) Clinical Trial
Official title:
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
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.
This is a prospective multicentric phase IV study, aiming at evaluating the immunogenicity and safety profile of RZV in PLWH over 50 years of age (YOA) on long term antiretroviral therapy (ART) (>10 years) compared to non-HIV age-matched adult controls to address the combined effect of aging and immunosuppression from HIV disease. Inclusion will be stratified as follow: HIV+ groups: - Group 1: PLWH registered in the SHCS or ANRS CO3, >75 YOA and under cART for more than 10 years - N=50 - Group 2: PLWH patients registered in the SHCS, aged between 60 and 75 and under cART for more than 10 years - N=50 - Group 3: PLWH patients registered in the SHCS, aged between 50 and 59 and under cART for more than 10 years - N=50 Control groups: - Group 4: Healthy adults aged >75 YOA- N=25 - Group 5: Healthy adults aged between 60 and 75 - N=25 - Group 6: Healthy adults aged between 50 and 59 - N=25 In addition, participants of all groups will be proposed to be included in the "Innate substudy" (target of 15 participants/group) and have two additional blood drawings 1 day after each vaccine dose to measure innate response triggered by RZV. Participants will receive Shingrix® on Day0 and Day60; immunological response will be assessed on Day 1, Day61, Day90, Day360. Unsolicited Adverse events of special intesrest (AESI) will be collected on Day 28, Day 60, Day90, Day360; patients reported outcomes (PROs) will be declared for one week after each vaccination. ;