Evidence map›Paper›PMID 29461919›Full record

Trial reportHuman vaccines & immunotherapeutics2018

Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults.

Tino F Schwarz, Stephanie Volpe, Gregory Catteau, Roman Chlibek, Marie Pierre David, Jan Hendrik Richardus, Himal Lal, Lidia Oostvogels, Karlis Pauksens, Stephanie Ravault and 5 more

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

Trial report in Human vaccines & immunotherapeutics, 2018. 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 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
7.8field-weighted citation impact, top 2% 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.

NCT00434577 phase2completednot on this map

A Phase II, Single-blind, Randomized, Controlled, Multicentre Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine, gE/AS01B, and to Compare 3 Doses of gE With AS01B Adjuvant in Healthy Elderly Subjects, Aged 60 to 69 Years and 70 Years and Above.

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2010Enrolled715ConditionsHerpes ZosterArmsHerpes Zoster vaccine GSK1437173A Low Dose, Herpes Zoster vaccine GSK1437173A Medium Dose, Herpes Zoster vaccine GSK1437173A High Dose, Herpes Zoster vaccine GSK1437173A Modified, Placebo
NCT02735915 phase3completednot on this map

Long Term Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine 1437173A and Assessment of Re-vaccination With 2 Additional Doses, in Healthy Subjects Aged 60 Years of Age and Older

TypeinterventionalSponsorGlaxoSmithKlineRan2016 to 2018Enrolled70ConditionsHerpes ZosterArmsHerpes Zoster Vaccine GSK1437173A
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 78 citations in OpenAlex.

  1. Pooled it
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  5. Review
  6. Review
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  13. Status of Herpes Zoster and Herpes Zoster Vaccines in 2023: A position paper.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2023
    Review
  14. Challenges in the Vaccination of the Elderly and Strategies for Improvement.Pathophysiology : the official journal of the International Society for Pathophysiology · 2023
    Review
  15. Review
  16. Immune Responses to Varicella-Zoster Virus Vaccines.Current topics in microbiology and immunology · 2023
    Article
  17. Review
  18. Review
  19. Review
  20. Article
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

15 authors at 10 institutions in 6 countries.

Tino F Schwarza Laboratory Medicine and Vaccination, Klinikum Würzburg Mitte , Standort Juliusspital, Würzburg , Germany.
Stephanie Volpeb Clinical R&D, GSK , Wavre , Belgium.
Gregory Catteauc Biostatistics & Statistical Programming, Clinical Evidence Generation, R&D, GSK , Wavre , Belgium.
Roman Chlibekd Department of Epidemiology, Faculty of Military Health Sciences , University of Defense , Hradec Kralove , Czech Republic.ORCID 0000-0002-7387-3844
Marie Pierre Davide Biostatistics & Statistical Programming, Clinical Evidence Generation, R&D, GSK , Rixensart , Belgium.
Jan Hendrik Richardusf Department of Infectious Disease Control , Municipal Public Health Service Rotterdam-Rijnmond , Rotterdam , The Netherlands.
Himal Lalg Clinical R&D, Pfizer Inc. , Collegeville , PA , USA.
Lidia Oostvogelsb Clinical R&D, GSK , Wavre , Belgium.
Karlis Pauksensh Medical Sciences, Section of Infectious Diseases, Uppsala University Hospital , Uppsala , Sweden.
Stephanie Ravaulti Clinical Laboratory Sciences, GSK , Rixensart , Belgium.
Lars Romboj Department of Medical Biochemistry and Microbiology , Zoonosis Science Center, Uppsala University , Uppsala , Sweden.
Gerard Sonderk Department of Infectious Diseases , Public Health Service of Amsterdam , Amsterdam , The Netherlands.
Jan Smetanad Department of Epidemiology, Faculty of Military Health Sciences , University of Defense , Hradec Kralove , Czech Republic.ORCID 0000-0002-3770-1754
Thomas Heinemanl Clinical Development, Genocea Biosciences , Cambridge , MA , USA.
Adriana Bastidasb Clinical R&D, GSK , Wavre , Belgium.
GlaxoSmithKline (Belgium) · BEUniversity of Defence · CZGenocea (United States) · USGGD Amsterdam · NLGGD Rotterdam-Rijnmond · NLKlinikum Würzburg Mitte · DEPfizer (United States) · USStatistics Belgium · BEUppsala University · SEUppsala University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn adults aged ≥60 years, two doses of the herpes zoster subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01

methodsThis open extension study (NCT02735915) followed 70 participants who received two HZ/su doses in the initial trial (NCT00434577). Blood samples to assess the cellular (intracellular cytokine staining) and humoral (ELISA) immunity were taken at year nine post-initial vaccination.

resultsParticipants' mean age at dose 1 was 72.3 years. The fold increases over pre-vaccination in the mean frequency of gE-specific CD4+ T-cells expressing ≥2 activation markers plateaued from year four post-dose 1 until year nine. Anti-gE antibody geometric mean concentrations plateaued and remained above pre-vaccination levels from year four onwards. Immunogenicity at year nine was similar across age strata (60-69, ≥70 years) and confirmed statistical prediction model results using data for up to year six. Further modeling using all data up to year nine predicted immune responses would remain above the pre-vaccination level up to year 15.

conclusionIn adults aged ≥60 years, HZ/su-induced immunogenicity remained above pre-vaccination levels for at least nine years post-initial vaccination. SUMMARY: After vaccination with HZ/su, both cell mediated and humoral immunity remained above pre-vaccination levels up to year 9 regardless of age group. Immune responses are predicted to remain above baseline up to 15 years post initial vaccination.

Indexed as

AdultAgedAged, 80 and overAntibodies, ViralCohort StudiesCytokinesFollow-Up StudiesHerpesvirus 3, HumanHerpes Zoster VaccineHumansLipid AMiddle AgedSaponinsTime FactorsT-LymphocytesVaccines, SubunitAntibodies, ViralAS01B adjuvantCytokinesHerpes Zoster VaccineLipid ASaponinsVaccines, Subunitherpes zosterherpes zoster (shingles) vaccineimmunitypersistenceprediction modelingpreventionsubunit gE vaccinevaricella-zoster virus

Identifiers

PMID29461919
PMCPMC6037441
OpenAlexW2794364315

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.