Shingr'HIVImmune 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
Recombinant Zoster Vaccine
Treatment Study
Summary
Study start date: December 14, 2022
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.225 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 50 to 95 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
Hôpital Saint-André, CHU de Bordeaux
Bordeaux, FranceOpen Hôpital Saint-André, CHU de Bordeaux in Google MapsSMIT - Service de Maladies Infectieuses et Tropicales Le Tripode -Groupe Hospitalier Pellegrin
Bordeaux, FranceCHU de Bordeaux - Hôpital Haut-Lévèque
Pessac, FranceUniversity Hospital Basel
Basel, Switzerland