Evidence map›Paper›PMID 36851245›Full record

ArticleVaccines2023

Double-Blind, Placebo-Controlled, Dose-Escalating Study Evaluating the Safety and Immunogenicity of an Epitope-Specific Chemically Defined Nanoparticle RSV Vaccine.

Isabel Leroux-Roels, Jacques Bruhwyler, Lilli Stergiou, Mark Sumeray, Jasper Joye, Cathy Maes, Paul-Henri Lambert, Geert Leroux-Roels

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–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

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
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  8. The recent landscape of RSV vaccine research.Therapeutic advances in vaccines and immunotherapy · 2025
    Review
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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

8 authors.

Isabel Leroux-RoelsCenter for Vaccinology (CEVAC), Ghent University Hospital, Corneel Heymanslaan 10, B-9000 Ghent, Belgium.
Jacques BruhwylerExpert Clinical Services Organization (ECSOR) sa/nv, Rue de la Station 78, B-1630 Linkebeek, Belgium.
Lilli StergiouVirometix AG, Wagistrasse 14, 8952 Schlieren, Switzerland.
Mark SumerayVirometix AG, Wagistrasse 14, 8952 Schlieren, Switzerland.
Jasper JoyeCenter for Vaccinology (CEVAC), Ghent University Hospital, Corneel Heymanslaan 10, B-9000 Ghent, Belgium.
Cathy MaesCenter for Vaccinology (CEVAC), Ghent University Hospital, Corneel Heymanslaan 10, B-9000 Ghent, Belgium.
Paul-Henri LambertDepartment of Paediatrics, Gynecology and Obstetrics, University of Geneva, Rue du Général Dufour 24, 1211 Geneva, Switzerland.
Geert Leroux-RoelsCenter for Vaccinology (CEVAC), Ghent University Hospital, Corneel Heymanslaan 10, B-9000 Ghent, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundV-306 is a virus-like particle-based vaccine candidate displaying respiratory syncytial virus (RSV) F site II protein mimetics (FsIIm) as an antigenic epitope.

methodsThis was a randomized, placebo-controlled, double-blind, dose-escalating, first-in-human study, conducted in 60 women aged 18-45 years. Twenty subjects per cohort (15 vaccine and five placebo) received two V-306 intramuscular administrations on Days 0 and 56 at 15 µg, 50 µg, or 150 µg. Safety and immunogenicity were assessed after each vaccination and for 1 year in total.

resultsV-306 was safe and well tolerated at all dose levels, with no increase in reactogenicity and unsolicited adverse events between the first and second administrations. At 50 µg and 150 µg, V-306 induced an increase in FsIIm-specific immunoglobulin G (IgG) titers, which lasted at least 4 months. This did not translate into an increase in RSV-neutralizing antibody titers, which were already high at baseline. No increase in the anti-F protein-specific IgG titers was observed, which were also high in most subjects at baseline due to past natural infections.

conclusionsV-306 was safe and well-tolerated. Future modifications of the vaccine and assay conditions will likely improve the results of vaccination.

Indexed as

FsIIm epitopehealthy volunteersimmunogenicityintramuscularphase Irespiratory syncytial virusRSVsafetyvaccine

Identifiers

PMID36851245
PMCPMC9967611

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.