Evidence map›Paper›PMID 41776715›Full record

Trial reportHuman vaccines & immunotherapeutics2026

A first-in-human Phase 1/1b randomized trial evaluating the safety and immunogenicity of a respiratory syncytial virus (RSV) virus-like particle subunit vaccine (IVX-121) in healthy young and older adults.

Ilse De Coster, Isabel Leroux-Roels, Kanchanamala Withanage, Leen Suykens, Valentino D'Onofrio, Geert Leroux-Roels, Pierre van Damme, Max Ciarlet, Elizabeth M Adams, Wasima Rida and 4 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

14 authors.

Ilse De CosterCentre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.ORCID 0000-0002-4847-2328
Isabel Leroux-RoelsCenter for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.ORCID 0000-0002-5084-4696
Kanchanamala WithanageCentre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
Leen SuykensCentre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
Valentino D'OnofrioCenter for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.
Geert Leroux-RoelsCenter for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.
Pierre van DammeCentre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
Max CiarletIcosavax, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Seattle, WA, USA.
Elizabeth M AdamsIcosavax, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Seattle, WA, USA.
Wasima RidaIcosavax, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Seattle, WA, USA.
Judy WenIcosavax, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Seattle, WA, USA.
Margaret MacDonaldIcosavax, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Seattle, WA, USA.
Jennifer PriceIcosavax, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Seattle, WA, USA.
Niranjan Kanesa-ThasanIcosavax, Vaccines and Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Seattle, WA, USA.ORCID 0000-0002-9346-5485

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract disease in all age groups, with substantial burden in older adults. Here, we report the safety and immunogenicity of IVX-121, an investigational virus-like particle vaccine against RSV. This Phase 1/1b trial (EudraCT number: 2020-003633-38) randomized 90 healthy young (18-45 y of age; Phase 1) and 130 older adults (60-75 y of age; Phase 1b) to receive a single intramuscular injection of IVX-121 at low (25 µg), medium (75 µg), or high (250 µg) dose, with/without the adjuvant aluminum hydroxide (Al[OH]

Indexed as

Immunogenicity, VaccineRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesVaccines, Virus-Like ParticleAdjuvants, ImmunologicAdolescentAdultAgedAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodFemaleHealthy VolunteersHumansInjections, IntramuscularAdjuvants, ImmunologicAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus VaccinesVaccines, SubunitVaccines, Virus-Like ParticleIVX-121respiratory syncytial virusRSVvaccinevirus-like particle

Identifiers

PMID41776715
PMCPMC12962668

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.