Evidence map›Paper›PMID 33606577›Full record

Trial reportHuman vaccines & immunotherapeutics2021

The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials.

Joon Hyung Kim, John Diaz-Decaro, Ning Jiang, Shinn-Jang Hwang, Eun Ju Choo, Maribel Co, Andrew Hastie, David Shu Cheong Hui, Junya Irimajiri, Jacob Lee and 10 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2021. 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 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.7field-weighted citation impact, top 17% 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
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 16 citations in OpenAlex.

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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

20 authors at 12 institutions in 9 countries.

Joon Hyung KimGSK, Rockville, MD, USA.ORCID 0000-0002-6014-3543
John Diaz-DecaroGSK, Rockville, MD, USA.ORCID 0000-0001-6487-2113
Ning JiangGSK, Beijing, China.
Shinn-Jang HwangDepartment of Family Medicine, Taipei Veterans General Hospital, Taipei City, Taiwan.ORCID 0000-0003-3217-6193
Eun Ju ChooDepartment of Infectious Diseases, SoonChunhyang University Bucheon Hospital, Bucheon-si, Republic of Korea.
Maribel CoGSK, Wavre, Belgium.
Andrew HastieGSK, Rockville, MD, USA.
David Shu Cheong HuiDepartment of Medicine and Therapeutics, The Chinese University of Hong Kong Prince of Wales Hospital, Sha Tin, Hong Kong.
Junya IrimajiriDepartment of Dermatology, Shonan Kamakura General Hospital, Kanagawa, Japan.
Jacob LeeDepartment of Internal Medicine, Division of Infectious Diseases, Kangnam Sacred Heart Hospital, Seoul, Republic of Korea.
Edward Man-Fuk LeungDepartment of Medicine and Geriatrics, Division of Geriatric Medicine and Rehabilitation, United Christian Hospital, Kwun Tong, Hong Kong.
Haiwen TangGSK, Shanghai, China.
Tomomi TsuruMedical CO.LTA PS Clinic, Fukuoka, Japan.
Philip WatsonGSK, Middlesex, UK.
Zhenhua WuGSK, Beijing, China.
Chong-Jen YuDepartment of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan.
Yanfei YuanGSK, Beijing, China.ORCID 0000-0002-5366-2599
Toufik ZahafGSK, Wavre, Belgium.ORCID 0000-0002-2049-5210
Anthony L CunninghamThe Westmead Institute for Medical Research, Westmead, Australia.ORCID 0000-0002-6744-5667
Anne SchuindGSK, Rockville, MD, USA.ORCID 0000-0003-3544-0682
GlaxoSmithKline (China) · CNGlaxoSmithKline (United States) · USGlaxoSmithKline (Belgium) · BEBucheon University · KRChinese University of Hong Kong · HKHallym University Kangnam Sacred Heart Hospital · KRMiddlesex University · GBNational Taiwan University Hospital · TWNational Yang Ming Chiao Tung University · TWShonan Kamakura General Hospital · JPThe University of Sydney · AUUnited Christian Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In two large clinical trials (ZOE-50 [NCT01165177] and ZOE-70 [NCT01165229]), two doses of the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy (VE) against herpes zoster (HZ) in adults ≥50 years of age (YOA). This post-hoc analysis assessed the VE against HZ and postherpetic neuralgia (PHN), in participants from Asian study sites enrolled in ZOE-50/70. Reactogenicity and safety were also assessed. Participants ≥50 YOA were randomized 1:1 to receive 2 doses of either RZV or placebo, 2 months apart. VE was evaluated for a median follow-up of 4 years post-vaccination overall and by age in the ZOE-50 Asian population ≥50 YOA and in the pooled ZOE-50/70 Asian population ≥70 YOA. Of the 2,729 participants included in the ZOE-50 Asian population ≥50 YOA, 3 RZV and 66 placebo recipients reported a confirmed HZ episode. Overall VE was 95.6% (95% confidence interval [CI]: 86.4-99.1) against HZ and 100% (95% CI: 35.44-100) against PHN. In the pooled ZOE-50/70 Asian population ≥70 YOA, 4 RZV and 75 placebo recipients out of the 2,723 participants reported a confirmed HZ episode. Overall VE was 94.7% (95% CI: 85.9-98.6) against HZ and 89.8% (95% CI: 28.39-99.77) against PHN. Pain and myalgia were the most frequent solicited local and general adverse events, respectively, in both populations. No safety concern was identified during the study periods. RZV is highly efficacious against HZ and PHN and has an acceptable safety profile in Asian populations ≥50 YOA, similar to what was observed in the general ZOE-50/70 populations.

Indexed as

Herpes ZosterHerpes Zoster VaccineNeuralgia, PostherpeticAdultCohort StudiesHerpesvirus 3, HumanHumansMiddle AgedHerpes Zoster VaccineAdjuvanted recombinant zoster vaccineAsian populationefficacyherpes zosterpostherpetic neuralgiasafety

Identifiers

PMID33606577
PMCPMC8189096
OpenAlexW3131952339

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.