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
Estudio de Tratamiento
Resumen
Fecha de inicio: 14 de diciembre de 2022
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 225 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 50 a 95 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
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)
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 10 ubicaciones
Hôpital Saint-André, CHU de Bordeaux
Bordeaux, FranceAbrir Hôpital Saint-André, CHU de Bordeaux en 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