Evidence map›Paper›PMID 32910152›Full record

SynthesisRheumatology (Oxford, England)2021

Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials.

Alemnew F Dagnew, Debora Rausch, Caroline Hervé, Toufik Zahaf, Myron J Levin, Anne Schuind, ZOE-50/70 study group

2 registry-linked trialsOpen access · hybridAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Rheumatology (Oxford, England), 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 41 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 3 pooled it
3.8field-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.

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

41 citing papers in PubMed, 3 syntheses or guidelines pooled it, 63 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

7 authors at 3 institutions in 2 countries.

Alemnew F DagnewGSK, Rockville, MD, USA.
Debora RauschGSK, Philadelphia, PA, USA.
Caroline HervéGSK, Wavre, Belgium.
Toufik ZahafGSK, Rixensart, Belgium.
Myron J LevinDepartments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Anne SchuindGSK, Rockville, MD, USA.
ZOE-50/70 study group
GlaxoSmithKline (United States) · USGlaxoSmithKline (Belgium) · BEUniversity of Colorado Anschutz Medical Campus · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ABSTRACT

objectiveIn the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials, the adjuvanted recombinant zoster vaccine (RZV) demonstrated ≥90% efficacy in preventing herpes zoster (HZ) in all age groups ≥50 years. Given the increased HZ risk associated with certain underlying autoimmune diseases or their treatment regimes, we conducted a post hoc analysis of RZV's efficacy against HZ and safety profile [specifically, the occurrence of serious adverse events (SAEs)] in ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies.

methodsAdults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomized to receive two doses of RZV or placebo 2 months apart. In this subgroup analysis of participants with at least one pIMD at enrolment, the efficacy was calculated for two-dose recipients who did not develop confirmed HZ before 30 days post-dose 2. SAE occurrence was evaluated for all participants who received at least one dose.

resultsOf the 14 645 RZV and 14 660 placebo recipients from the ZOE-50/70 studies, 983 and 960, respectively, reported at least one pre-existing pIMD at enrolment and were included in these analyses. The most frequent pre-existing conditions were psoriasis, spondyloarthropathy and RA. Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70-79-year-old age group. SAEs and fatal SAEs were similar between RZV and placebo recipients.

conclusionIn ZOE-50/70 participants with pre-existing pIMDs, RZV was highly efficacious against HZ and SAE incidence was similar between RZV and placebo recipients.

trial registrationClinicalTrials.gov, https://clinicaltrials.gov, NCT01165177 (ZOE-50), NCT01165229 (ZOE-70).

Indexed as

Herpes Zoster VaccineAgedArthritis, RheumatoidCeliac DiseaseClinical Trials, Phase III as TopicFemaleHerpes ZosterHumansMaleMiddle AgedPsoriasisRandomized Controlled Trials as TopicSpondylarthropathiesVaccines, SyntheticHerpes Zoster VaccineVaccines, Syntheticpotential immune-mediated diseasespsoriasisrheumatoid arthritisspondyloarthropathyvaccinesvaricella-zoster virus

Identifiers

PMID32910152
PMCPMC7937016
OpenAlexW3084765871

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.