Evidence map›Paper›PMID 29529222›Full record

Trial reportThe Journal of infectious diseases2018

Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older.

Anthony L Cunningham, Thomas C Heineman, Himal Lal, Olivier Godeaux, Roman Chlibek, Shinn-Jang Hwang, Janet E McElhaney, Timo Vesikari, Charles Andrews, Won Suk Choi and 14 more

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 114 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 1 pooled it
14.1field-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.

NCT01165177 phase3completednot on this map

Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2015Enrolled16,165ConditionsHerpes ZosterArmsHerpes Zoster Vaccine GSK1437173A, Placebo
NCT01165229 phase3completednot on this map

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2015Enrolled14,819ConditionsHerpes Zoster, Herpes Zoster VaccineArmsHerpes Zoster Vaccine GSK1437173A, Placebo
NCT05879419 phase4active not recruitingnot on this mapstarted 2023, after this paper: background citation

Efficacy, Immunogenicity and Safety of Recombinant Vaccine Against Herpes Zoster (RZV or SHINGRIX®) in Patients With Autoimmune Rheumatic Diseases

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2023 to 2032Enrolled2,005ConditionsRheumatoid Arthritis, Spondylitis, Ankylosing, Spondyloarthritis, Systemic Lupus ErythematosusArmsRecombinant Herpes Zoster Vaccine (RZV), MTX Discontinuation, MMF Discontinuation, Placebo, MTX maintain
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

114 citing papers in PubMed, 1 synthesis or guideline pooled it, 192 citations in OpenAlex.

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  17. Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals.Journal of the American Geriatrics Society · 2021
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54 more citing papers are in PubMed but not listed here.

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

24 authors at 14 institutions in 11 countries.

Anthony L CunninghamThe Westmead Institute for Medical Research, University of Sydney, Australia.
Thomas C HeinemanGSK, King of Prussia, Pennsylvania.
Himal LalGSK, King of Prussia, Pennsylvania.
Olivier GodeauxGSK, Wavre, Belgium.
Roman ChlibekFaculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.
Shinn-Jang HwangDepartment of Family Medicine, Taipei Veterans General Hospital, and National Yang Ming University School of Medicine, Taiwan.
Janet E McElhaneyHealth Sciences North Research Institute, Sudbury, Ontario, Canada.
Timo VesikariVaccine Research Center, University of Tampere, Finland.
Charles AndrewsDiagnostics Research Group, San Antonio, Texas.
Won Suk ChoiDivision of Infectious Disease, Department of Internal Medicine, Korea University College of Medicine, Seoul.
Meral EsenInstitute of Tropical Medicine, University Clinic of Tuebingen, Germany.
Hideyuki IkematsuJapan Physicians Association, Kanda, Chiyoda-ku, Tokyo.
Martina Kovac ChomaGSK, Rockville, Maryland.
Karlis PauksensDepartment of Infectious Diseases, Uppsala University Hospital, Sweden.
Stéphanie RavaultGSK, Rixensart, Belgium.
Bruno SalaunGSK, Rixensart, Belgium.
Tino F SchwarzCentral Laboratory and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Germany.
Jan SmetanaFaculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.
Carline Vanden AbeeleGSK, Wavre, Belgium.
Peter Van den SteenGSK, Wavre, Belgium.
Ilse VastiauGSK, Wavre, Belgium.
Lily Yin WeckxFederal University of Sao Paulo, Brazil.
Myron J LevinDepartment of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora.
ZOE-50/70 Study Group
GlaxoSmithKline (Belgium) · BEUniversity of Defence · CZDiagnostics Research Group · USGlaxoSmithKline (United States) · USHealth Sciences North · CAKlinikum Würzburg Mitte · DEKorea University · KRTaipei Veterans General Hospital · TWTampere University · FIUniversidade Federal de São Paulo · BRUniversity of Colorado Anschutz Medical Campus · USUniversity of Tübingen · DEUppsala University Hospital · SEWestmead Institute for Medical Research · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The herpes zoster subunit vaccine (HZ/su), consisting of varicella-zoster virus glycoprotein E (gE) and AS01B Adjuvant System, was highly efficacious in preventing herpes zoster in the ZOE-50 and ZOE-70 trials. We present immunogenicity results from those trials. Methods: Participants (ZOE-50: ≥50; ZOE-70: ≥70 years of age) received 2 doses of HZ/su or placebo, 2 months apart. Serum anti-gE antibodies and CD4 T cells expressing ≥2 of 4 activation markers assessed (CD42+) after stimulation with gE-peptides were measured in subcohorts for humoral (n = 3293) and cell-mediated (n = 466) immunogenicity. Results: After vaccination, 97.8% of HZ/su and 2.0% of placebo recipients showed a humoral response. Geometric mean anti-gE antibody concentrations increased 39.1-fold and 8.3-fold over baseline in HZ/su recipients at 1 and 36 months post-dose 2, respectively. A gE-specific CD42+ T-cell response was shown in 93.3% of HZ/su and 0% of placebo recipients. Median CD42+ T-cell frequencies increased 24.6-fold (1 month) and 7.9-fold (36 months) over baseline in HZ/su recipients and remained ≥5.6-fold above baseline in all age groups at 36 months. The proportion of CD4 T cells expressing all 4 activation markers increased over time in all age groups. Conclusions: Most HZ/su recipients developed robust immune responses persisting for 3 years following vaccination. Clinical Trials Registration: NCT01165177; NCT01165229.

Indexed as

Adjuvants, ImmunologicAgedAntibodies, ViralCD4-Positive T-LymphocytesFemaleHerpesvirus 3, HumanHerpes ZosterHerpes Zoster VaccineHumansImmunity, CellularImmunity, HumoralImmunogenicity, VaccineLipid AMaleMiddle AgedSaponinsAdjuvants, ImmunologicAntibodies, ViralAS01B adjuvantglycoprotein E, varicella-zoster virusHerpes Zoster VaccineLipid ASaponinsVaccines, SubunitViral Envelope Proteins

Identifiers

PMID29529222
PMCPMC5946839
OpenAlexW2789400684

What OpenQuestion holds

Textmetadata
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.