Evidence map›Paper›PMID 39036981›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

A Randomized, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of VIR-2482 in Healthy Adults for Prevention of Influenza A Illness (PENINSULA).

Susanna K Tan, Deborah Cebrik, David Plotnik, Maria L Agostini, Keith Boundy, Christy M Hebner, Wendy W Yeh, Phillip S Pang, Jaynier Moya, Charles Fogarty and 2 more

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

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05567783 (A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT05567783 phase2terminatednot on this map

A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A

TypeinterventionalSponsorVir Biotechnology, Inc.Ran2022 to 2023Enrolled2,977ConditionsInfluenza AArmsVIR-2482 (450 mg), VIR-2482 (1200 mg), Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Trial
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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

12 authors.

Susanna K TanVir Biotechnology, Inc., San Francisco, California, USA.ORCID 0000-0001-5835-8660
Deborah CebrikVir Biotechnology, Inc., San Francisco, California, USA.
David PlotnikVir Biotechnology, Inc., San Francisco, California, USA.
Maria L AgostiniVir Biotechnology, Inc., San Francisco, California, USA.
Keith BoundyVir Biotechnology, Inc., San Francisco, California, USA.
Christy M HebnerVir Biotechnology, Inc., San Francisco, California, USA.
Wendy W YehVir Biotechnology, Inc., San Francisco, California, USA.
Phillip S PangVir Biotechnology, Inc., San Francisco, California, USA.
Jaynier MoyaPines Care Research Center, Inc., Pembroke Pines, Florida, USA.
Charles FogartySpartanburg Medical Research, Spartanburg, South Carolina, USA.
Manuchehr DaraniMarvel Clinical Research, Long Beach, California, USA.
Frederick G HaydenDivision of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, Virginia, USA.

Funding

Administration for Strategic Preparedness and ResponseBiomedical Advanced Research and Development Authority 75A50122C00081HHSVir Biotechnology, Inc
6 · The paper itself

Abstract

backgroundInfluenza A results in significant morbidity and mortality. VIR-2482, an engineered human monoclonal antibody with extended half-life, targets a highly conserved epitope on the stem region of influenza A hemagglutinin and may protect against seasonal and pandemic influenza.

methodsThis double-blind, randomized, placebo-controlled, phase 2 study examined the safety and efficacy of VIR-2482 for seasonal influenza A illness prevention in unvaccinated healthy adults. Participants (N = 2977) were randomized 1:1:1 to receive VIR-2482 450 mg, VIR-2482 1200 mg, or placebo via intramuscular injection. Primary and secondary efficacy endpoints were the proportions of participants with reverse transcriptase-polymerase chain reaction-confirmed influenza A infection and either protocol-defined influenza-like illness (ILI) and Centers for Disease Control and Prevention-defined ILI or World Health Organization-defined ILI, respectively.

resultsVIR-2482 450 mg and 1200 mg prophylaxis did not reduce the risk of protocol-defined ILI with reverse transcriptase-polymerase chain reaction-confirmed influenza A versus placebo (relative risk reduction, 3.8% [95% confidence interval (CI), -67.3 to 44.6] and 15.9% [95% CI, -49.3 to 52.3], respectively). At the 1200-mg dose, the relative risk reductions in influenza A illness were 57.2% (95% CI: -2.5 to 82.2) using Centers for Disease Control and Prevention ILI and 44.1% (95% CI: -50.5 to 79.3) using World Health Organization ILI definitions, respectively. Serum VIR-2482 levels were similar regardless of influenza status; variants with reduced VIR-2482 susceptibility were not detected. Local injection site reactions were mild and similar across groups.

conclusionsVIR-2482 1200 mg intramuscular was well tolerated but did not significantly prevent protocol-defined ILI. Secondary endpoint analyses suggest this dose may have reduced influenza A illness. Trial registration: ClinicalTrials.gov identifier, NCT05567783.

Indexed as

Influenza, HumanAdolescentAdultAgedAntibodies, MonoclonalAntibodies, ViralDouble-Blind MethodFemaleHealthy VolunteersHumansInfluenza A virusInfluenza VaccinesInjections, IntramuscularMaleMiddle AgedYoung AdultAntibodies, MonoclonalAntibodies, ViralInfluenza Vaccinesinfluenza Amonoclonal antibodyphase 2 clinical trialseasonal influenza preventionVIR-2482

Identifiers

PMID39036981
PMCPMC11478579

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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.