Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls
- Conditions
- RZV Vaccine (Shingrix ®)
- Interventions
- Registration Number
- NCT05575830
- Lead Sponsor
- Calmy Alexandra
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 225
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
-
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RZV or Shingrix®) Recombinant Zoster Vaccine Recombinant Zoster Vaccine
- Primary Outcome Measures
Name Time Method Geometric mean titer (GMT) of gE-specific total IgG Day 90 gE-specific total IgG titers is determined by gE-specific ELISA from sera samples
- Secondary Outcome Measures
Name Time Method Vaccine safety - AESI 7 days 7 days Incidence adverse events of special interest (AESI) in the 7 days following each vaccination (reactogenicity) collected in a diary card
Vaccine safety - PLWH Day 90 In PLWH: Percentage of PLWH with viral load \>50 copies/ml one month after the second RZV vaccination (D90)
Vaccine immunogenicity - CD4+ T cells Day 90 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
Vaccine safety - SAE 360 days 360 days Incidence of SAE throughout the study period
Vaccine safety -pIMDs 360 days Incidence of potential immune mediated disorders (pIMDs) throughout the study period
Trial Locations
- Locations (10)
CHU de Bordeaux - Hôpital Haut-Lévèque
🇫🇷Pessac, Gironde, France
SMIT - Service de Maladies Infectieuses et Tropicales Le Tripode -Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Hôpital Saint-André, CHU de Bordeaux
🇫🇷Bordeaux, France
Kantonsspital
🇨🇭St Gallen, Saint Gallen, Switzerland
Ente Ospedaliero Cantonale
🇨🇭Lugano, Ticino, Switzerland
Centre Hospitalier Universitaire Vaudoise (CHUV)
🇨🇭Lausanne, Vaud, Switzerland
University Hospital Basel
🇨🇭Basel, Switzerland
Bern University Hospital (Inselspital)
🇨🇭Bern, Switzerland
University Hospitals of Geneva
🇨🇭Geneva, Switzerland
University Hospital Zurich
🇨🇭Zurich, Switzerland