Evidence map›Paper›PMID 37335963›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

No Immunological Interference or Safety Concerns When Adjuvanted Recombinant Zoster Vaccine Is Coadministered With a Coronavirus Disease 2019 mRNA-1273 Booster Vaccine in Adults Aged 50 Years and Older: A Randomized Trial.

Abdi Naficy, Adrienne Kuxhausen, Paola Pirrotta, Brett Leav, Jacqueline Miller, Kate Anteyi, Jasur Danier, Thomas Breuer, Agnes Mwakingwe-Omari

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05047770 (A Phase III, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Immune Response and Safety of Both Herpes Zoster Subunit Vaccine in Healthy Adults Aged 50 Years and Older AND the Influenza Virus Vaccine in Healthy Adults Aged 18 Years and Older When Administered Sequentially or Coadministered With mRNA-1273 Booster Vaccination), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

NCT05047770 phase3completednot on this map

A Phase III, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Immune Response and Safety of Both Herpes Zoster Subunit Vaccine in Healthy Adults Aged 50 Years and Older AND the Influenza Virus Vaccine in Healthy Adults Aged 18 Years and Older When Administered Sequentially or Coadministered With mRNA-1273 Booster Vaccination

TypeinterventionalSponsorGlaxoSmithKlineRan2021 to 2022Enrolled2,013ConditionsHerpes ZosterArmsHZ/su, Flu D-QIV, mRNA-1273
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Herpes Zoster in Aging Patients: Risk Factors and Prevention Strategies.International journal of general medicine · 2026
    Review
  5. Article
  6. Review
  7. Review
  8. 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

9 authors at 2 institutions in 2 countries.

Abdi NaficyClinical Sciences, GSK, Rockville, Maryland, USA.ORCID 0000-0002-1076-5280
Adrienne KuxhausenBiostatistics, GSK, Rockville, Maryland, USA.ORCID 0000-0002-7663-7409
Paola PirrottaSafety Evaluation & Risk Management, GSK, Wavre, Belgium.ORCID 0000-0002-1465-4529
Brett LeavInfectious Disease Development, Moderna, Inc, Cambridge, Massachusetts, USA.ORCID 0000-0003-0907-0817
Jacqueline MillerInfectious Disease Development, Moderna, Inc, Cambridge, Massachusetts, USA.ORCID 0000-0002-7083-2182
Kate AnteyiClinical Safety & Pharmacovigilance, Moderna, Inc, Cambridge, Massachusetts, USA.ORCID 0000-0001-5027-4753
Jasur DanierClinical Sciences, GSK, Rockville, Maryland, USA.ORCID 0000-0002-5032-8333
Thomas BreuerGlobal Health, GSK, Tres Cantos, Spain.ORCID 0000-0003-2532-0505
Agnes Mwakingwe-OmariClinical Sciences, GSK, Rockville, Maryland, USA.ORCID 0000-0002-6576-1981
Moderna Therapeutics (United States) · USGlaxoSmithKline (Belgium) · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is growing consensus that coronavirus disease 2019 booster vaccines may be coadministered with other age-appropriate vaccines. Adding to the limited available data supporting coadministration, especially with adjuvanted vaccines, could enhance vaccine coverage in adults.

methodsIn this phase 3, randomized, open-label study, eligible adults aged ≥50 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and a first dose of recombinant zoster vaccine (RZV1) 2 weeks apart (Seq group) or concomitantly (Coad group). The second RZV dose (RZV2) was administered 2 months post-RZV1 in both groups. Primary objectives were noninferiority of anti-glycoprotein E (gE) and anti-spike protein antibody responses in the Coad group compared to the Seq group. Safety and further immunogenicity assessments were secondary objectives.

resultsIn total, 273 participants were randomized to the Seq group and 272 to the Coad group. Protocol-specified noninferiority criteria were met. The adjusted geometric mean concentration ratio (Seq/Coad) was 1.01 (95% confidence interval [CI], .89-1.13) for anti-gE antibodies 1 month post-RZV2, and 1.09 (95% CI, .90-1.32) for anti-spike antibodies 1 month post-mRNA-1273 booster. No clinically relevant differences were observed in overall frequency, intensity, or duration of adverse events between the 2 study groups. Most solicited adverse events were mild/moderate in intensity, each with median duration ≤2.5 days. Administration site pain and myalgia were the most frequently reported in both groups.

conclusionsCoadministration of mRNA-1273 booster vaccine with RZV in adults aged ≥50 years was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines administered sequentially. Clinical Trials Registration. NCT05047770.

Indexed as

COVID-19Herpes ZosterHerpes Zoster Vaccine2019-nCoV Vaccine mRNA-1273Adjuvants, ImmunologicAgedAntibodies, ViralCOVID-19 VaccinesHumansImmunogenicity, VaccineMiddle AgedVaccines, Synthetic2019-nCoV Vaccine mRNA-1273Adjuvants, ImmunologicAntibodies, ViralCOVID-19 VaccinesHerpes Zoster VaccineVaccines, SyntheticcoadministrationimmunogenicitymRNA COVID-19 vaccinerecombinant zoster vaccinesafety

Identifiers

PMID37335963
PMCPMC10640691
OpenAlexW4381308227

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.