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Immune response to the recombinant herpes zoster vaccine in people living with HIV over 50 years of age compared to non-HIV age-/gender-matched controls (SHINGR'HIV): a multicenter, international, non-randomized clinical trial study protocol

dc.rights.licenseopenen_US
dc.contributor.authorHENTZIEN, Maxime
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorBONNET, Fabrice
dc.contributor.authorBERNASCONI, Enos
dc.contributor.authorBIVER, Emmanuel
dc.contributor.authorBRAUN, Dominique L.
dc.contributor.authorMUNTING, Aline
dc.contributor.authorLEUZINGER, Karoline
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLELEUX, Olivier
dc.contributor.authorMUSARDO, Stefano
dc.contributor.authorPRENDKI, Virginie
dc.contributor.authorSCHMID, Patrick
dc.contributor.authorSTAEHELIN, Cornelia
dc.contributor.authorSTOECKLE, Marcel
dc.contributor.authorWALTI, Carla S.
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorWITTKOP, Linda
hal.structure.identifierImmunology from Concept and Experiments to Translation = Immunologie Conceptuelle, Expérimentale et Translationnelle [ImmunoConcept]
dc.contributor.authorAPPAY, Victor
dc.contributor.authorDIDIERLAURENT, Arnaud M.
dc.contributor.authorCALMY, Alexandra
dc.date.accessioned2024-08-21T13:26:31Z
dc.date.available2024-08-21T13:26:31Z
dc.date.issued2024-03-19
dc.identifier.issn1471-2334en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/201238
dc.description.abstractEnBackground The burden of herpes zoster (shingles) virus and associated complications, such as post-herpetic neuralgia, is higher in older adults and has a significant impact on quality of life. The incidence of herpes zoster and post-herpetic neuralgia is increased in people living with HIV (PLWH) compared to an age-matched general population, including PLWH on long-term antiretroviral therapy (ART) with no detectable viremia and normal CD4 counts. PLWH - even on effective ART may- exhibit sustained immune dysfunction, as well as defects in cells involved in the response to vaccines. In the context of herpes zoster, it is therefore important to assess the immune response to varicella zoster virus vaccination in older PLWH and to determine whether it significantly differs to that of HIV-uninfected healthy adults or younger PLWH. We aim at bridging these knowledge gaps by conducting a multicentric, international, non-randomised clinical study (SHINGR'HIV) with prospective data collection after vaccination with an adjuvant recombinant zoster vaccine (RZV) in two distinct populations: in PLWH on long-term ART (> 10 years) over 50 years of and age/gender matched controls. Methods We will recruit participants from two large established HIV cohorts in Switzerland and in France in addition to age-/gender-matched HIV-uninfected controls. Participants will receive two doses of RZV two months apart. In depth-evaluation of the humoral, cellular, and innate immune responses and safety profile of the RZV will be performed to address the combined effect of aging and potential immune deficiencies due to chronic HIV infection. The primary study outcome will compare the geometric mean titer (GMT) of gE-specific total IgG measured 1 month after the second dose of RZV between different age groups of PLWH and between PLWH and age-/gender-matched HIV-uninfected controls. Discussion The SHINGR'HIV trial will provide robust data on the immunogenicity and safety profile of RZV in older PLWH to support vaccination guidelines in this population. Trial registration ClinicalTrials.gov NCT05575830. Registered on 12 October 2022. Eu Clinical Trial Register (EUCT number 2023-504482-23-00).
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enAS01
dc.subject.enAging
dc.subject.enHIV infection
dc.subject.enHerpes zoster
dc.subject.enImmunogenicity
dc.subject.enPrevention
dc.subject.enRecombinant zoster vaccine
dc.subject.enShingrix®
dc.subject.enVaricella-zoster virus
dc.title.enImmune response to the recombinant herpes zoster vaccine in people living with HIV over 50 years of age compared to non-HIV age-/gender-matched controls (SHINGR'HIV): a multicenter, international, non-randomized clinical trial study protocol
dc.title.alternativeBMC Infect Disen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s12879-024-09192-5en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed38504173en_US
bordeaux.journalBMC Infectious Diseasesen_US
bordeaux.page329en_US
bordeaux.volume24en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionINRIAen_US
bordeaux.institutionCNRS
bordeaux.teamGHIGS_BPHen_US
bordeaux.teamSISTM_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDGlaxoSmithKlineen_US
bordeaux.identifier.funderIDInstitut de Recherche pour le Développementen_US
bordeaux.identifier.funderIDAgence Nationale de Recherches sur le Sida et les Hépatites Viralesen_US
bordeaux.identifier.funderIDSidactionen_US
hal.identifierhal-04674638
hal.version1
hal.date.transferred2024-08-21T13:26:34Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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