Evidence map›Paper›PMID 28068212›Full record

Trial reportHuman vaccines & immunotherapeutics2017

Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial.

Olivier Godeaux, Martina Kovac, Daniel Shu, Katrijn Grupping, Laura Campora, Martine Douha, Thomas C Heineman, Himal Lal

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01827839 (Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster), which is not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
4.7field-weighted citation impact, top 5% 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.

NCT01827839 phase3completednot on this map

Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2014Enrolled96ConditionsHerpes ZosterArmsHerpes Zoster vaccine (GSK1437173A)
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
  2. Current status of immunisation for herpes zoster.Human vaccines & immunotherapeutics · 2025
    Review
  3. A Survey on Knowledge and Attitudes Towards Vaccination Against Herpes Zoster Virus Among Medical Oncologists for Patients with Solid Tumors.Journal of cancer education : the official journal of the American Association for Cancer Education · 2025
    Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Immunization in women's lives: present and future.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2024
    Article
  11. Review
  12. [Vaccination in old age: an overview].Zeitschrift fur Gerontologie und Geriatrie · 2023
    Article
  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. Article
  15. Review
  16. Article
  17. Article
  18. Article
  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

8 authors at 2 institutions in 2 countries.

Olivier Godeauxa GSK Vaccines , Wavre , Belgium.
Martina Kovaca GSK Vaccines , Wavre , Belgium.
Daniel Shub Gain Medical Centre , Coquitlam , BC , Canada.
Katrijn Gruppinga GSK Vaccines , Wavre , Belgium.
Laura Camporaa GSK Vaccines , Wavre , Belgium.
Martine Douhaa GSK Vaccines , Wavre , Belgium.
Thomas C Heinemanc GSK Vaccines , King of Prussia , PA , USA.
Himal Lalc GSK Vaccines , King of Prussia , PA , USA.
GlaxoSmithKline (Belgium) · BECoquitlam College · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase III, non-randomized, open-label, multi-center study (NCT01827839) evaluated the immunogenicity and safety of an adjuvanted recombinant subunit herpes zoster (HZ) vaccine (HZ/su) in adults aged ≥ 50 y with prior physician-documented history of HZ. Participants (stratified by age: 50-59, 60-69 and ≥ 70 y) received 2 doses of HZ/su 2 months apart and were followed-up for another 12 months. Anti-glycoprotein E (gE) antibodies were measured by enzyme-linked immunosorbent assay before vaccination and 1 month after the second dose (Month 3). Solicited local and general adverse events (AEs) were recorded for 7 d and unsolicited AEs for 30 d after each vaccination. Serious AEs were recorded until study end. The primary immunogenicity objective was met if the lower limit of the 95% confidence interval (CI) of the vaccine response rate (VRR), defined as a 4-fold increase in anti-gE over baseline, at Month 3 was ≥ 60%. 96 participants (32/age group) were enrolled. The primary immunogenicity objective was met, as the VRR at Month 3 was 90.2% (95% CI: 81.7-95.7). Geometric mean anti-gE antibody concentrations at Month 3 were similar across age groups. 77.9% and 71.6% of participants reported local and general solicited AEs, respectively. The most frequent solicited AEs were pain at injection site, fatigue, headache, myalgia and shivering. The HZ/su vaccine was immunogenic in adults aged ≥ 50 y with a physician-documented history of HZ, and no safety concerns were identified.

Indexed as

Adjuvants, ImmunologicImmunogenicity, VaccineAgedAntibodies, ViralAntibody FormationCD4-Positive T-LymphocytesDrug-Related Side Effects and Adverse ReactionsEnzyme-Linked Immunosorbent AssayFemaleHerpesvirus 3, HumanHerpes ZosterHerpes Zoster VaccineHumansMaleMiddle AgedVaccines, SubunitAdjuvants, ImmunologicAntibodies, Viralglycoprotein E, varicella-zoster virusHerpes Zoster VaccineVaccines, SubunitViral Envelope Proteinsherpes zosterimmunogenicitysafetyvaricella-zoster viruszoster vaccine

Identifiers

PMID28068212
PMCPMC5443374
OpenAlexW2569903330

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.