Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls

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.

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)