Evidence map›Paper›PMID 33197294›Full record

Trial reportJournal of the American Geriatrics Society2021

Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals.

Desmond Curran, Joon H Kim, Sean Matthews, Christophe Dessart, Myron J Levin, Lidia Oostvogels, Megan E Riley, Kenneth E Schmader, Anthony L Cunningham, Shelly A McNeil and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Geriatrics Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03563183 (Observational Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022 and HZ Efficacy, Immunogenicity and Safety of HZ/su by Frailty Status), which is not on this map. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
4.7field-weighted citation impact, top 4% 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.

NCT03563183 completednot on this map

Observational Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022 and HZ Efficacy, Immunogenicity and Safety of HZ/su by Frailty Status

TypeobservationalSponsorGlaxoSmithKlineRan2018 to 2019Enrolled26,976ConditionsHerpes ZosterArmsEncoding of data collected in Zoster 006 and Zoster 022 studies
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Observational
  8. Herpes Zoster in Aging Patients: Risk Factors and Prevention Strategies.International journal of general medicine · 2026
    Review
  9. Current status of immunisation for herpes zoster.Human vaccines & immunotherapeutics · 2025
    Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Review
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

13 authors at 6 institutions in 4 countries.

Desmond CurranGSK, Wavre, Belgium.ORCID 0000-0002-7423-0111
Joon H KimGSK, Rockville, Maryland, USA.
Sean MatthewsFreelance c/o GSK, Wavre, Belgium.
Christophe DessartGSK, Wavre, Belgium.
Myron J LevinDepartments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Lidia OostvogelsGSK, Wavre, Belgium.
Megan E RileyGSK, Rockville, Maryland, USA.
Kenneth E SchmaderDivision of Geriatrics, Duke University Medical Center and GRECC, Durham Veterans Affairs Medical Center, Durham, North Carolina, USA.
Anthony L CunninghamThe Westmead Institute for Medical Research, Westmead, University of Sydney, Sydney, Australia.
Shelly A McNeilCanadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Canada.
Anne E SchuindGSK, Rockville, Maryland, USA.
Melissa K AndrewDivision of Geriatric Medicine, Department of Medicine, Dalhousie University, Halifax, Canada.
Zoster-064 Study Group
GlaxoSmithKline (Belgium) · BEGlaxoSmithKline (United States) · USDalhousie University · CAGeriatric Research Education and Clinical Center · USThe University of Sydney · AUUniversity of Colorado Anschutz Medical Campus · US

Funding

Resource Core 3 - Metabolomics CoreP30AG028716 · NIA · DUKE UNIVERSITY · PI CATHLEEN S COLON-EMERIC, Susan Nicole Hastings · 2006 to 2026
$24.6M
NIA NIH HHS P30 AG028716
6 · The paper itself

Abstract

BACKGROUND/

objectivesFrail participants are often under-represented in randomized trials, raising questions about outcomes of interventions in real-world settings. Frailty is strongly associated with vulnerability to illness and adverse health outcomes. We studied the impact of frailty on recombinant zoster vaccine (RZV) clinical outcomes. DESIGN/

settingData from two previously conducted phase III randomized trials of RZV were pooled. These two parent trials were conducted concurrently at the same study sites using the same methods. PARTICIPANTS/

interventionIn the two parent studies, participants aged ≥50 years (ZOE-50 study) and ≥70 years (ZOE-70 study), respectively, were randomized 1:1 to receive two doses of RZV or placebo. MEASUREMENTS: In the current ZOE-Frailty study (NCT03563183), a frailty index was created using previously validated methods. Clinical outcomes assessed by frailty status included vaccine efficacy, immunogenicity, reactogenicity, and safety.

resultsOf 29,305 participants from the pooled ZOE-50 and ZOE-70 total vaccinated cohort, 92% were included in this study. Mean age was 68.8 years; 58.1% were women; 45.6% were pre-frail and 11.3% frail. The percentage of frail participants increased with age from 5.7% aged 50-59 years to 22.7% aged ≥80 years. RZV vaccine efficacy against herpes zoster was >90% for all frailty subgroups (non-frail: 95.8% (95% confidence interval = 91.6-98.2), pre-frail: 90.4% (84.4-94.4), frail: 90.2% (75.4-97.0)). The RZV group demonstrated robust anti-gE antibody and gE-specific CD4

conclusionThe relatively nonrestrictive inclusion/exclusion criteria in the parent ZOE studies resulted in a range of participants that included frail and pre-frail older adults. RZV significantly reduced the risk of herpes zoster across all frailty subgroups.

Indexed as

AgedAged, 80 and overFemaleFrail ElderlyHerpes ZosterHerpes Zoster VaccineHumansMaleMiddle AgedVaccinationVaccines, SyntheticHerpes Zoster VaccineVaccines, Syntheticfrailherpes zosterolder adultsquality of lifesubunit vaccine

Identifiers

PMID33197294
PMCPMC7984267
OpenAlexW3104230834

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.