Evidence map›Paper›PMID 34653245›Full record

Trial reportThe Journal of infectious diseases2022

Phase 1 Randomized, Placebo-Controlled, Dose-Escalating Study to Evaluate OVX836, a Nucleoprotein-Based Influenza Vaccine: Intramuscular Results.

Kanchanamala Withanage, Ilse De Coster, Nathalie Cools, Simonetta Viviani, Jessika Tourneur, Marion Chevandier, Manon Lambiel, Paul Willems, Alexandre Le Vert, Florence Nicolas and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.1field-weighted citation impact, top 12% 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.

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, 17 citations in OpenAlex.

  1. Trial
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  4. OligoDOMFrontiers in immunology · 2025
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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

11 authors at 2 institutions in 2 countries.

Kanchanamala WithanageVaccine and Infectious Disease Institute (VaxInfectio), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerpen, Belgium.
Ilse De CosterVaccine and Infectious Disease Institute (VaxInfectio), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerpen, Belgium.
Nathalie CoolsLaboratory of Experimental Hematology, Vaccine and Infectious Disease Institute (VaxInfectio), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerpen, Belgium.
Simonetta VivianiIndependent Scientific Advisor on Vaccines, Epidemiology and Public Health, 10 Via Gramsci, I-53100 Monteriggioni, Siena, Italy.
Jessika TourneurOsivax, Lyon, France.
Marion ChevandierOsivax, Lyon, France.
Manon LambielOsivax, Lyon, France.
Paul WillemsOsivax, Lyon, France.
Alexandre Le VertOsivax, Lyon, France.
Florence NicolasOsivax, Lyon, France.
Pierre Van DammeVaccine and Infectious Disease Institute (VaxInfectio), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerpen, Belgium.
Abivax (France) · FRUniversity of Antwerp · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOVX836 is a recombinant protein vaccine targeting the highly conserved influenza nucleoprotein (NP), which could confer broad-spectrum protection against this disease.

methodsA randomized, placebo-controlled, double-blind, dose-escalating, single- center, first-in-human study was conducted in 36 healthy adults aged 18-49 years. Twelve subjects per cohort (9 vaccine and 3 placebo) received 2 OVX836 intramuscular administrations on days 1 and 28 at the dose level of 30 µg, 90 µg, or 180 µg. Safety and immunogenicity were assessed after each vaccination and for 150 days in total.

resultsOVX836 was safe and well tolerated at all dose levels, with no difference in solicited local and systemic symptoms, and unsolicited adverse events between the first and second administration, or between dose levels. All subjects presented pre-existing NP-specific immunity at baseline. OVX836 induced a significant increase in NP-specific interferon-gamma T cells and anti-NP immunoglobulin G at all dose levels after the first vaccination. The second vaccination did not further increase the response. There was a trend for a dose effect in the immune response.

conclusionsThe safety and reactogenicity profile, as well as the humoral and cellular immune responses, encourage further evaluation of OVX836 in a larger Phase 2a study.

Indexed as

Influenza, HumanInfluenza VaccinesAdultAntibodies, ViralDouble-Blind MethodHumansImmunogenicity, VaccineNucleoproteinsVaccinationVaccines, SyntheticAntibodies, ViralInfluenza VaccinesNucleoproteinsVaccines, SyntheticinfluenzanucleoproteinOVX836Phase 1vaccine

Identifiers

PMID34653245
PMCPMC9373130
OpenAlexW3206764012

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.