Clinical trial NCT05575830: Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: RZV Vaccine (Shingrix ®)
Keywords: RZV vaccine
PLWH
Immune response
Safety
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 225
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Geometric mean titer (GMT) of gE-specific total IgG
timeFrame: Day 90
Secondary outcomes:
measure: Vaccine safety - AESI 7 days
timeFrame: 7 days
measure: Vaccine safety - SAE 360 days
timeFrame: 360 days
measure: Vaccine safety -pIMDs
timeFrame: 360 days
measure: Vaccine safety - PLWH
timeFrame: Day 90
measure: Vaccine immunogenicity - CD4+ T cells
timeFrame: Day 90
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital Haut-Lévèque
state: Gironde
city: Bordeaux
country: France
facility: SMIT - Service de Maladies Infectieuses et Tropicales Le Tripode -Groupe Hospitalier Pellegrin
city: Bordeaux
country: France
facility: Hôpital Saint-André, CHU de Bordeaux
city: Lugano
country: Switzerland
facility: Ente Ospedaliero Cantonale
state: Ticino
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudoise (CHUV)
state: Vaud
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Bern University Hospital (Inselspital)
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
city: St Gallen
country: Switzerland
facility: Kantonsspital
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospitals of Geneva, Infectious disease department,
name: Alexandra Calmy, Prof. MD
role: STUDY_DIRECTOR
References: