Evidence map›Paper›PMID 34283213›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70.

Céline Boutry, Andrew Hastie, Javier Diez-Domingo, Juan Carlos Tinoco, Chong-Jen Yu, Charles Andrews, Jean Beytout, Covadonga Caso, Huey-Shinn Cheng, Hee Jin Cheong and 32 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 59 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 1 pooled it
9.3field-weighted citation impact, top 1% 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.

NCT02723773 phase3completednot on this map

Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults

TypeinterventionalSponsorGlaxoSmithKlineRan2016 to 2024Enrolled7,539ConditionsHerpes Zoster, Herpes Zoster VaccineArmsHerpes Zoster Vaccine GSK1437173A
NCT07527247 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Using AS01 Adjuvant to Improve Immune Response in Older Adults Through Trained Immunity

TypeinterventionalSponsorSingapore General HospitalRan2025 to 2029Enrolled40ConditionsImmune System Responses and Trained Immunity After AS01 Administration, Healthy AdultArmsAS01 adjuvant (0.5 mL intramuscular), YF17D (Stamaril, Sanofi-Pasteur), Placebo (NaCl 09%, 0.5mL)
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 1 synthesis or guideline pooled it, 91 citations in OpenAlex.

  1. Pooled it
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  6. Review
  7. Article
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  10. Informing decisions in light of parameter uncertainty - an economic evaluation of the adjuvanted recombinant herpes zoster vaccine in Sweden.The European journal of health economics : HEPAC : health economics in prevention and care · 2026
    Article
  11. Article
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  14. Current status of immunisation for herpes zoster.Human vaccines & immunotherapeutics · 2025
    Review
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  18. Trends in public interest and vaccination coverage for Herpes Zoster.Public health in practice (Oxford, England) · 2025
    Article
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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

42 authors at 20 institutions in 13 countries.

Céline BoutryAixial, an Alten Company, Brussels, Belgium, C/O GSK, Wavre, Belgium.
Andrew HastieGSK, Rockville, Maryland, USA.
Javier Diez-DomingoFISABIO Fundación para el Fomento Investigación Sanitaria y Biomédica de la Comunitat Valenciana, Valencia, Spain.
Juan Carlos TinocoHospital General de Durango, Durango, Mexico.
Chong-Jen YuDepartment of Internal Medicine, National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei, Taiwan.
Charles AndrewsDiagnostics Research Group, San Antonio, Texas, USA.
Jean BeytoutService CIC, CHU Clermont-Ferrand, Clermont-Ferrand, France.
Covadonga CasoServicio de Prevención, Hospital Clínico San Carlos, Madrid, Spain.
Huey-Shinn ChengLinkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan.
Hee Jin CheongKorea University Guro Hospital, Seoul, Republic of Korea.
Eun Ju ChooSoonChunhyang University Bucheon Hospital, Bucheon-si, Republic of Korea.
Dan CuriacClinical Trial Center, SU/Sahlgrenska Universitetssjukhuset, Göteborg, Sweden.
Emmanuel Di PaoloGSK, Rixensart, Belgium.
Marc DionneCHU de Québec-Université Laval, Québec City, Canada.
Tamara EckermannPraxisgemeinschaft Heimeranplatz, München, Germany.
Meral EsenInstitute of Tropical Medicine, Universitätsklinikum Tübingen, Tübingen, Germany.
Murdo FergusonColchester Research Group, Truro, Canada.
Wayne GhesquiereDivision of Infectious Diseases, UBC, Island Health Authority, PerCuro Clinical Research Ltd., Victoria, Canada.
Shinn-Jang HwangTaipei Veterans General Hospital, Taipei City, Taiwan.
Thiago Junqueira Avelino-SilvaLaboratório de Investigação Médica em Envelhecimento (LIM-66), Serviço de Geriatria, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Pavel KosinaDepartment of Infectious Diseases, Hradec Kralove, Czechia.
Chiu-Shong LiuOccupational Medicine and Family Medicine, China Medical University Hospital, Taichung, Taiwan.
Jukka MarkkulaPori Vaccine Research Clinic, Vaccine Research Center, Tampere University, Pori, Finland.
Beate MoeckeschPraxis Dr. med. Beate Moeckesch, Weinheim, Germany.
Cláudia Murta de OliveiraAmbulatório de Pesquisa Clínica, Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte, Brazil.
Dae Won ParkKorea University Ansan Hospital, Ansan, Republic of Korea.
Karlis PauksensAkademiska sjukhuset, Infektionskliniken, Uppsala, Sweden.
Paola PirrottaGSK, Wavre, Belgium.
Georg PlassmannUHZ Klinische Forschung, Essen, Germany.
Carol PretswellSynexus Lancashire Clinical Research Centre, Chorley, United Kingdom.
Lars RomboClinical Research Centre, Eskilstuna, Sweden.
Bruno SalaunGSK, Rixensart, Belgium.
Johan Sanmartin BerglundBlekinge Institute of Technology, Department of Health, Karlstrona, Sweden.
Isabelle SchenkenbergerKFB- Klinische Forschung Berlin, Berlin, Germany.
Tino SchwarzInstitute of Laboratory Medicine and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg, Germany.
Meng ShiGSK, Rockville, Maryland, USA.
Benita UkkonenEspoo Vaccine Research Clinic, Vaccine Research Center, Tampere University, Espoo, Finland.
Toufik ZahafGSK, Wavre, Belgium.
Cristiano ZerbiniCentro Paulista de Investigação Clínica, CEPIC, São Paulo, Brazil.
Anne SchuindGSK, Rockville, Maryland, USA.
Anthony L CunninghamThe Westmead Institute for Medical Research, Westmead, NSW, Australia.
Zoster-049 Study Group
Program for Appropriate Technology in Health · USGlaxoSmithKline (Belgium) · BEBlekinge Institute of Technology · SEGlaxoSmithKline (United States) · USNational Yang Ming Chiao Tung University · TWChina Medical University · TWGesellschaft für Klinische Forschung · DEUniversity Consortium of Pori · FIUppsala University Hospital · SEBucheon University · KRCentro Paulista de Investigação Clinica · BRDiagnostics Research Group · USEskilstuna Municipality · SEFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESGrupo Santa Casa de Belo Horizonte · BRHospital Clínico San Carlos · ESHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRIsland Health · CAKlinikum Würzburg Mitte · DEKorea University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age ≥50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after ≥2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination.

methodsAnnual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing ≥2 of 4 assessed activation markers) frequencies from Y5 post-vaccination.

resultsOf 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels.

conclusionsEfficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination. Clinical Trials Registration. NCT02723773.

Indexed as

Herpes ZosterHerpes Zoster VaccineAdjuvants, ImmunologicAgedFollow-Up StudiesHerpesvirus 3, HumanHumansMiddle AgedVaccines, SyntheticAdjuvants, ImmunologicHerpes Zoster VaccineVaccines, Syntheticadjuvanted recombinant zoster vaccineimmune response persistencelong-term efficacy

Identifiers

PMID34283213
PMCPMC9049256
OpenAlexW3186328747

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.