Evidence map›Paper›PMID 38504173›Full record

ArticleBMC infectious diseases2024

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.

Maxime Hentzien, Fabrice Bonnet, Enos Bernasconi, Emmanuel Biver, Dominique L Braun, Aline Munting, Karoline Leuzinger, Olivier Leleux, Stefano Musardo, Virginie Prendki and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05575830 (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), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05575830 phase4active not recruitingnot on this map

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

TypeinterventionalSponsorCalmy AlexandraRan2022 to 2026Enrolled225ConditionsRZV Vaccine (Shingrix ®)ArmsRecombinant Zoster Vaccine
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 2 countries.

Maxime Hentzien *HIV/AIDS Unit, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.
Fabrice Bonnet *CHU de Bordeaux, Hôpital Saint-André, Service de Médecine Interne et Maladies Infectieuses, Bordeaux, France.
Enos BernasconiDepartment of Infectious Diseases, Ente Ospedaliero Cantonale, Lugano, Switzerland.
Emmanuel BiverDivision of Bone Diseases, Geneva University Hospitals, Geneva, Switzerland.
Dominique L BraunDivision Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Aline MuntingService of Infectious Diseases, Centre Hospitalier Universitaire Vaudoise (CHUV), Lausanne, Switzerland.
Karoline LeuzingerClinical Virology, University Hospital Basel, Basel, Switzerland.
Olivier LeleuxUniversité de Bordeaux, INSERM, Institut Bergonié, BPH, U1219, CIC-EC 1401, Bordeaux, F-33000, France.
Stefano MusardoHIV/AIDS Unit, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.
Virginie PrendkiDivision of Infectious Disease, Geneva University Hospital, Geneva, Switzerland.
Patrick SchmidDivision of Infectious Diseases and Hospital Epidemiology, Kantonsspital, St Gallen, Switzerland.
Cornelia StaehelinDepartment of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.
Marcel StoeckleDivision of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.
Carla S WaltiDivision of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.
Linda WittkopCHU de Bordeaux, Hôpital Saint-André, Service de Médecine Interne et Maladies Infectieuses, Bordeaux, France.
Victor AppayUniversité de Bordeaux, CNRS UMR 5164, INSERM ERL 1303, ImmunoConcEpT, Bordeaux, 33000, France.
Arnaud M DidierlaurentDepartment of Pathology and Immunology, Center of Vaccinology, Faculty of Medicine, University of Geneva, Geneva, Switzerland. arnaud.didierlaurent@unige.ch.
Alexandra CalmyHIV/AIDS Unit, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland. Alexandra.Calmy@hug.ch.
University Hospital of Geneva · CHUniversity Hospital of Basel · CHUniversité de Bordeaux · FRCentre National de la Recherche Scientifique · FREnte Ospedaliero Cantonale · CHInstitut national de recherche en sciences et technologies du numérique · FRKantonsspital St. Gallen · CHUniversity Hospital of Lausanne · CHUniversity of Bern · CHUniversity of Geneva · CHUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsWe 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 registrationClinicalTrials.gov NCT05575830. Registered on 12 October 2022. Eu Clinical Trial Register (EUCT number 2023-504482-23-00).

Indexed as

Herpes ZosterHerpes Zoster VaccineHIV InfectionsNeuralgia, PostherpeticAgedHerpesvirus 3, HumanHumansImmunityMiddle AgedMulticenter Studies as TopicNon-Randomized Controlled Trials as TopicQuality of LifeVaccines, SyntheticHerpes Zoster VaccineVaccines, SyntheticAgingAS01Herpes zosterHIV infectionImmunogenicityPreventionRecombinant zoster vaccineShingrix®Varicella-zoster virus

Identifiers

PMID38504173
PMCPMC10949601
OpenAlexW4392956172

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.