Evidence map›Paper›PMID 42054374›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026

Immunogenicity and Safety of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine When Co-administered With the Adjuvanted Recombinant Herpes Zoster Subunit Vaccine in Adults ≥ 50 Years of Age.

Jean-François Roussy, Patrick Dennis, Anil K Gupta, Garry Wallace, Alexander Abitbol, Naresh Aggarwal, Joseph G Surber, Theodore Lee, Brian A Smith, Catherine Gérard and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05966090 (A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT05966090 phase3completednot on this map

A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years and Older

TypeinterventionalSponsorGlaxoSmithKlineRan2023 to 2024Enrolled530ConditionsRespiratory Syncytial Viruses, Respiratory Syncytial Virus InfectionsArmsRSVPreF3 OA investigational vaccine, HZ/su vaccine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. AS01Drug safety · 2026
    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

15 authors.

Jean-François RoussyDIEX Research, Québec, Québec, Canada.
Patrick DennisDELRIGHT Research, New Orleans, Louisiana, USA.
Anil K GuptaAlbion Finch Medical Center, Toronto, Ontario, Canada.
Garry WallaceDawson Clinical Research, Guelph, Ontario, Canada.
Alexander AbitbolLMC Healthcare/Centricity Research, Toronto, Ontario, Canada.ORCID 0000-0001-6830-3532
Naresh AggarwalAggarwal and Associates, Brampton, Ontario, Canada.
Joseph G SurberCentricity Research Talbotton, Columbus, Georgia, USA.
Theodore LeeHeadlands Research, Orlando, Florida, USA.
Brian A SmithCCT Research, Versailles, Kentucky, USA.ORCID 0009-0009-1572-3248
Catherine GérardGSK, Rixensart, Belgium.
Hiwot Amare HailemariamGSK, Wavre, Belgium.
Marie-Pierre DavidGSK, Wavre, Belgium.
Archana M JastorffGSK, Wavre, Belgium.
Marie Van der WielenGSK, Wavre, Belgium.ORCID 0009-0006-3808-8767
RSV-020 Study Group

Funding

GSK
6 · The paper itself

Abstract

backgroundCo-administration of AS01E-adjuvanted respiratory syncytial virus vaccine (adjuvanted RSVPreF3) and AS01B-adjuvanted recombinant herpes zoster subunit vaccine (RZV), although not contraindicated, has not been previously studied in clinical trials.

methodsThis phase III, open-label, randomized (1:1) trial evaluated the immunogenicity, safety, and reactogenicity of adjuvanted RSVPreF3 when co-administered with RZV in ≥50-year-olds. The 2 vaccines were either co-administered at visit 1 (day [D] 1; Co-Ad), or were given sequentially, 1 month apart (RZV dose 1 at D1, adjuvanted RSVPreF3 at D31; Control). All participants received RZV dose-2 at D61. Non-inferiority of humoral immune responses was demonstrated if 95% confidence interval (CI) upper limits for geometric mean RSV-A/B neutralizing titers (GMT) and varicella-zoster virus anti-glycoprotein E (anti-gE) antibody concentration (GMC) ratios (Control/Co-Ad) were ≤1.5. Safety and reactogenicity were secondary endpoints.

resultsOverall, 530 participants (Co-Ad = 265; Control = 265) were vaccinated. Neutralizing GMT ratios for RSV-A (1.1 [95% CI = 1.0-1.4]) and RSV-B (1.0 [0.8-1.2]), and anti-gE antibody GMC ratio (1.2 [1.1-1.4]) met non-inferiority criteria. Within 7 days post-vaccination, 71.7% (Co-Ad: post-RZV dose 1 and adjuvanted RSVPreF3; grade [Gr] 3 = 3.9%), 58.5% (Control: post-RZV dose 1; Gr3 = 1.9%), and 47.8% (Control: post-adjuvanted RSVPreF3; Gr3 = 1.2%) of participants reported solicited administration-site adverse events (AEs). Post-visit 1, 73.6% (Gr3 = 9.3%) of Co-Ad and 60.4% (Gr3 = 6.2%) of control participants reported solicited systemic AEs. Within 30 days post-any vaccination, 23.4% (Gr3 = 0.8%) of Co-Ad and 30.2% (Gr3 = 1.1%) of control participants reported unsolicited AEs. No fatal or related serious AEs were reported.

conclusionsImmunogenicity, reactogenicity, and safety data support the co-administration of adjuvanted RSVPreF3 and RZV. CLINICAL TRIALS REGISTRATION: NCT05966090.

Indexed as

Adjuvants, ImmunologicHerpes Zoster VaccineImmunogenicity, VaccineRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesViral Fusion ProteinsAdjuvants, VaccineAgedAged, 80 and overAntibodies, NeutralizingAntibodies, ViralFemaleHerpes ZosterHumansMaleAdjuvants, ImmunologicAdjuvants, VaccineAntibodies, NeutralizingAntibodies, ViralF protein, human respiratory syncytial virusHerpes Zoster VaccineProtein Subunit VaccinesRespiratory Syncytial Virus VaccinesVaccines, SubunitVaccines, SyntheticViral Fusion Proteinsadjuvanted vaccinesco-administrationherpes zosterrespiratory syncytial virussafety

Identifiers

PMID42054374
PMCPMC13644881

What OpenQuestion holds

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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.