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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 \u2013 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\u2019HIV) with prospective data collection after vaccination with an adjuvant recombinant zoster vaccine (RZV) in two distinct populations: in PLWH on long-term ART (&gt;\u200910 years) over 50 years of and age\/gender matched controls.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The SHINGR\u2019HIV trial will provide robust data on the immunogenicity and safety profile of RZV in older PLWH to support vaccination guidelines in this population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT05575830. Registered on 12 October 2022. Eu Clinical Trial Register (EUCT number 2023-504482-23-00).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12879-024-09192-5","type":"journal-article","created":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T06:05:12Z","timestamp":1710828312000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["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\u2019HIV): a multicenter, international, non-randomized clinical trial study protocol"],"prefix":"10.1186","volume":"24","author":[{"given":"Maxime","family":"Hentzien","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrice","family":"Bonnet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enos","family":"Bernasconi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Biver","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique L.","family":"Braun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aline","family":"Munting","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karoline","family":"Leuzinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Leleux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Musardo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginie","family":"Prendki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Schmid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelia","family":"Staehelin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel","family":"Stoeckle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla S.","family":"Walti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Wittkop","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Appay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnaud M.","family":"Didierlaurent","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Calmy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,3,19]]},"reference":[{"issue":"2","key":"9192_CR1","doi-asserted-by":"publisher","first-page":"e0229224","DOI":"10.1371\/journal.pone.0229224","volume":"15","author":"I Matthews","year":"2020","unstructured":"Matthews I, Duong M, Parsons VL, Nozad B, Qizilbash N, Patel Y, et al. 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Available from:https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/shingrix-epar-product-information_en.pdf"}],"container-title":["BMC Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12879-024-09192-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12879-024-09192-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12879-024-09192-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T07:03:58Z","timestamp":1710831838000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcinfectdis.biomedcentral.com\/articles\/10.1186\/s12879-024-09192-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,19]]},"references-count":44,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["9192"],"URL":"https:\/\/doi.org\/10.1186\/s12879-024-09192-5","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-3955771\/v1","asserted-by":"object"}]},"ISSN":["1471-2334"],"issn-type":[{"value":"1471-2334","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,3,19]]},"assertion":[{"value":"14 February 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 March 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 March 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This trial has received ethical approval from the Geneva Cantonal Commission for Ethics and Research (CCER - BASEC 2022\u2009\u2212\u200901314) on 20 October 2022, and by the relevant ethics commissions: Kantonale Ethikkommission Bern (14 November 2022), EKNZ (Ethikkommission Nordwest- und Zentralschweiz, 20 November 2022), EKOS (Ethikkommission Ostschweiz, 2 November 2022), Ethikkommission Tessin (24 November 2022), Commission cantonale d\u2019\u00e9thique de la recherche sur l\u2019\u00eatre humain CER-VD (8 November 2022) and Ethikkommission Z\u00fcrich (1 November 2022). In France the protocol has been approved by the \u201cComit\u00e9 de Protection des Personnes\u201d and by the \u201cAgence nationale de s\u00e9curit\u00e9 du medicament et des produits de sant\u00e9\u201d on July 20, 2023. The study will be conducted in accordance with the Declaration of Helsinki and with each country\u2019s laws and regulations, as well as with Guidelines for Good Clinical Practice for biomedical research on drugs for human use and ICH Good Clinical Practice E6 (R2) 9 November 2016, European Regulation EU no. 536\/2014, and Good Clinical Laboratory Practice (World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases, 2009). Participants must provide signed and dated written informed consent prior to undergoing any study-specific procedure. Participants will have the opportunity to provide consent for the use of health-related data and samples for research purposes.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"DLB reports honoraria for advisory boards payed to himself from the companies AstraZeneca, Gilead, MSD, Pfizer and ViiV. ADM reports honoraria for participation to scientific advisory boards of Speransa, Bioaster, Sanofi, to Data Safety Monitoring Board for AMC Biosciences and speaker bureau for Roche and Merck. All the other authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"329"}}