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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
225
Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60
Hôpital Saint-André, CHU de Bordeaux
Bordeaux, Bordeaux, France
SMIT - Service de Maladies Infectieuses et Tropicales Le Tripode -Groupe Hospitalier Pellegrin
Bordeaux, France, France
CHU de Bordeaux - Hôpital Haut-Lévèque
Pessac, Gironde, France
Geometric mean titer (GMT) of gE-specific total IgG
gE-specific total IgG titers is determined by gE-specific ELISA from sera samples
Time frame: Day 90
Vaccine safety - AESI 7 days
Incidence adverse events of special interest (AESI) in the 7 days following each vaccination (reactogenicity) collected in a diary card
Time frame: 7 days
Vaccine safety - SAE 360 days
Incidence of SAE throughout the study period
Time frame: 360 days
Vaccine safety -pIMDs
Incidence of potential immune mediated disorders (pIMDs) throughout the study period
Time frame: 360 days
Vaccine safety - PLWH
In PLWH: Percentage of PLWH with viral load \>50 copies/ml one month after the second RZV vaccination (D90)
Time frame: Day 90
Vaccine immunogenicity - CD4+ T cells
Mean of gE-specific CD4+ T cells expressing at least 2 activation markers (i.e. CD40L, IFN-gamma, IL-2 or TNF-alpha) per million of T cells, measured at D90
Time frame: Day 90
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University Hospital Basel
Basel, Basel, Switzerland
Bern University Hospital (Inselspital)
Bern, Canton of Bern, Switzerland
University Hospitals of Geneva
Geneva, Canton of Geneva, Switzerland
Kantonsspital
Sankt Gallen, Canton of St. Gallen, Switzerland
Centre Hospitalier Universitaire Vaudoise (CHUV)
Lausanne, Canton of Vaud, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Ente Ospedaliero Cantonale
Lugano, Canton Ticino, Switzerland