Evidence map›Paper›PMID 38376227›Full record

Trial reportAntimicrobial agents and chemotherapy2024

A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness.

David Plotnik, Jennifer E Sager, Madhukar Aryal, Marie C Fanget, Alessia Peter, Michael A Schmid, Deborah Cebrik, Erik Mogalian, Keith Boundy, Wendy W Yeh and 2 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.3field-weighted citation impact, top 5% 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

9 citing papers in PubMed, 11 citations in OpenAlex.

  1. A Randomized, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of VIR-2482 in Healthy Adults for Prevention of Influenza A Illness (PENINSULA).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
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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 at 3 institutions in 3 countries.

David PlotnikVir Biotechnology, San Francisco, California, USA.ORCID 0000-0003-0688-8613
Jennifer E SagerVir Biotechnology, San Francisco, California, USA.
Madhukar AryalVir Biotechnology, San Francisco, California, USA.
Marie C FangetVir Biotechnology, San Francisco, California, USA.
Alessia PeterHumabs BioMed, SA, Vir Biotechnology, Bellinzona, Switzerland.
Michael A SchmidHumabs BioMed, SA, Vir Biotechnology, Bellinzona, Switzerland.
Deborah CebrikVir Biotechnology, San Francisco, California, USA.
Erik MogalianVir Biotechnology, San Francisco, California, USA.
Keith BoundyVir Biotechnology, San Francisco, California, USA.
Wendy W YehVir Biotechnology, San Francisco, California, USA.
Paul GriffinMater Health and University of Queensland, Queensland, Australia.
Maribel ReyesVir Biotechnology, San Francisco, California, USA.
VIR Biotechnology (United States) · USVir Biotechnology (Switzerland) · CHMater Health Services · AU

Funding

Vir Biotechnology Inc. (Vir)
6 · The paper itself

Abstract

The objective of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of VIR-2482 in healthy adult subjects. A phase 1, first-in-human, randomized, double-blind, placebo-controlled dose-escalation study was conducted. One hundred participants were allocated to four cohorts (60 mg, 300 mg, 1,200 mg, and 1,800 mg). In each cohort, participants were randomized in a 4:1 ratio (active:placebo) to receive either VIR-2482 or volume-matched placebo by gluteal intramuscular injection. Participants remained at the investigative site under observation for 48 h, and adverse events (AEs) were collected for 56 days. PK and immunogenicity were measured up to 52 weeks post-dose. VIR-2482 was well tolerated at all doses studied. The overall incidence of AEs was comparable between VIR-2482 (68.8%) and placebo (85.0%). Nineteen VIR-2482 (23.8%) and six placebo (30.0%) recipients had Grade 1 or 2 AEs that were considered to be related to the study intervention. There were no treatment-related serious AEs. Injection-site reactions (ISRs) were reported in six (7.5%) VIR-2482 recipients, while no such reactions were reported among the placebo recipients. All ISRs were Grade 1, and there was no relationship with the dose. Median VIR-2482 serum elimination half-life ranged from 56.7 to 70.6 days across cohorts. The serum area under the curve and

Indexed as

Antibodies, MonoclonalInfluenza, HumanAdultDouble-Blind MethodHealthy VolunteersHumansAntibodies, Monoclonalhuman immunoglobulin G1influenzamonoclonal antibodiesprophylaxisVIR-2482

Identifiers

PMID38376227
PMCPMC10988998
OpenAlexW4391955933

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Registered trials

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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.