Evidence map›Paper›PMID 34406911›Full record

Trial reportHuman vaccines & immunotherapeutics2021

Adjuvanted recombinant zoster vaccine in adult autologous stem cell transplant recipients: polyfunctional immune responses and lessons for clinical practice.

Edward A Stadtmauer, Keith M Sullivan, Mohamed El Idrissi, Bruno Salaun, Aránzazu Alonso Alonso, Charalambos Andreadis, Veli-Jukka Anttila, Adrian Jc Bloor, Raewyn Broady, Claudia Cellini and 20 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01610414 (Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A), which is not on this map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 pooled it
3.6field-weighted citation impact, top 6% 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.

NCT01610414 phase3completednot on this map

Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2017Enrolled1,877ConditionsHerpes ZosterArmsHerpes Zoster vaccine GSK1437173A, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Vaccination of Adults With Cancer: ASCO Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
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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

30 authors at 20 institutions in 11 countries.

Edward A StadtmauerUniversity of Pennsylvania, Philadelphia, PA, USA.
Keith M SullivanDivision of Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, NC, USA.ORCID 0000-0002-1379-9216
Mohamed El IdrissiGSK, Rue de l'Institut 89, Rixensart, Belgium.ORCID 0000-0002-3306-3062
Bruno SalaunGSK, Rue de l'Institut 89, Rixensart, Belgium.ORCID 0000-0002-8927-8660
Aránzazu Alonso AlonsoHospital Quirón Madrid, Pozuelo de Alarcón, Spain.
Charalambos AndreadisUniversity of California Medical Center, San Francisco, CA, USA.ORCID 0000-0003-4681-6227
Veli-Jukka AnttilaInflammation Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Adrian Jc BloorHaematology and Transplant Unit, The Christie NHS Foundation Trust, Manchester, UK.
Raewyn BroadyVancouver General Hospital, Vancouver, BC, Canada.
Claudia CelliniU.O. di Ematologia, Ospedale Santa Maria Delle Croci, Ravenna, Italy.ORCID 0000-0002-8707-8542
Antonio CuneoUnità Operativa di Ematologia, Azienda Osp. Universitaria Arcispedale S. Anna, Cona, Italy.
Alemnew F DagnewGSK, Rockville, MD, USA.ORCID 0000-0003-4181-058X
Emmanuel Di PaoloGSK, Rue de l'Institut 89, Rixensart, Belgium.
HyeonSeok EomNational Cancer Center, Goyang-si, Republic of Korea.
Ana Pilar González-RodríguezHospital Universitario Central de Asturias, Oviedo, Spain.
Andrew GriggDepartment of Clinical Haematology, Austin Health, Heidelberg, Australia.
Andreas GuentherUniversitaetsklinikum Schleswig-Holstein, Kiel, Germany.
Thomas C HeinemanHalozyme Therapeutics, San Diego, CA, USA.ORCID 0000-0003-4500-5676
Isidro JarqueHematology Department & CIBERONC, Instituto Carlos III, Hospital Universitario y Politécnico la fe, Valencia, Spain.
Jae-Yong KwakChonbuk National University Hospital, DukJin-Gu, Republic of Korea.
Alessandro LucchesiHematology Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Lidia OostvogelsCureVac AG, Tübingen, Germany.ORCID 0000-0003-1298-0360
Marta Polo ZarzuelaHospital Clínico San Carlos, Madrid, Spain.ORCID 0000-0002-6241-1089
Anne E SchuindGSK, Rockville, MD, USA.ORCID 0000-0003-3544-0682
Thomas C SheaDivision of Hematology and Medical Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Ulla Marjatta SinisaloHematology Unit, Department of Internal Medicine, Tampere University Hospital, Tampere, Finland.
Filiz VuralEge University Medical Faculty Hospital, Izmir, Turkey.ORCID 0000-0003-3489-296X
Lucrecia Yáñez San SegundoHematology Department, Hospital Universitario Marqués De Valdecilla-IDIVAL, University of Cantabria, Santander, Spain.ORCID 0000-0001-9925-3048
Pierre ZachéeHematologie - Oncologie, Ziekenhuisnetwerk Antwerpen - ZNA Stuivenberg & ZNA Middelheim, Antwerpen, Belgium.ORCID 0000-0002-2275-5143
Adriana BastidasGSK, Wavre, Belgium.ORCID 0000-0001-5429-4022
GlaxoSmithKline (Belgium) · BEGlaxoSmithKline (United States) · USArcispedale Sant'Anna · ITAustin Health · AUCureVac (Germany) · DEDuke Medical Center · USEge University · TRHalozyme Therapeutics (United States) · USHospital Clínico San Carlos · ESHospital Universitari i Politècnic La Fe · ESHospital Universitario Central de Asturias · ESHospital Universitario Quirónsalud Madrid · ESIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITJeonbuk National University Hospital · KRNational Cancer Center · KROspedale Santa Maria · ITTampere University Hospital · FIThe Christie NHS Foundation Trust · GBUniversidad de Cantabria · ESUniversity of California San Francisco Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Immunocompromised individuals, particularly autologous hematopoietic stem cell transplant (auHSCT) recipients, are at high risk for herpes zoster (HZ). We provide an in-depth description of humoral and cell-mediated immune (CMI) responses by age (protocol-defined) or underlying disease (post-hoc) as well as efficacy by underlying disease (post-hoc) of the adjuvanted recombinant zoster vaccine (RZV) in a randomized observer-blind phase III trial (ZOE-HSCT, NCT01610414). 1846 adult auHSCT recipients were randomized to receive a first dose of either RZV or placebo 50-70 days post-auHSCT, followed by the second dose at 1-2 months (M) later. In cohorts of 114-1721 participants, at 1 M post-second vaccine dose: Anti-gE antibody geometric mean concentrations (GMCs) and median gE-specific CD4[2+] T-cell frequencies (CD4 T cells expressing ≥2 of four assessed activation markers) were similar between 18-49 and ≥50-year-olds. Despite lower anti-gE antibody GMCs in non-Hodgkin B-cell lymphoma (NHBCL) patients, CD4[2+] T-cell frequencies were similar between NHBCL and other underlying diseases. The proportion of polyfunctional CD4 T cells increased over time, accounting for 79.6% of gE-specific CD4 T cells at 24 M post-dose two. Vaccine efficacy against HZ ranged between 42.5% and 82.5% across underlying diseases and was statistically significant in NHBCL and multiple myeloma patients. In conclusion, two RZV doses administered early post-auHSCT induced robust, persistent, and polyfunctional gE-specific immune responses. Efficacy against HZ was also high in NHBCL patients despite the lower humoral response.

Indexed as

Hematopoietic Stem Cell TransplantationHerpes ZosterHerpes Zoster VaccineHerpesvirus 3, HumanHumansImmunity, CellularVaccine EfficacyHerpes Zoster Vaccineadjuvanted recombinant zoster vaccineAutologous hematopoietic stem cell transplantcell-mediated immunityhumoral immune responsepolyfunctionalityvaccine efficacy

Identifiers

PMID34406911
PMCPMC8828160
OpenAlexW3193727596

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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.