immune response of shingrix vaccine in people living with hiv (> 50 y.o.) compared to age-matched controls

Conditions: RZV Vaccine (Shingrix ®)

Summary: 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.

Eligibility criteria:
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)

Keywords: rzv vaccine plwh immune response safety