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

Calmy Alexandra

Status and phase

Active, not recruiting

Phase 4

Conditions

RZV Vaccine (Shingrix ®)

Treatments

Biological: Recombinant Zoster Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT05575830

2022-01314

2023-504482-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

225 estimated patients

Sex

All

Ages

50 to 95 years old

Volunteers

Accepts Healthy Volunteers

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)