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Clinical Trial
. 2024 Oct 15;79(4):1054-1061.
doi: 10.1093/cid/ciae368.

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  1 , Deborah Cebrik  1 , David Plotnik  1 , Maria L Agostini  1 , Keith Boundy  1 , Christy M Hebner  1 , Wendy W Yeh  1 , Phillip S Pang  1 , Jaynier Moya  2 , Charles Fogarty  3 , Manuchehr Darani  4 , Frederick G Hayden  5
Affiliations
Clinical Trial

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 et al. Clin Infect Dis. .

Abstract

Background: Influenza 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.

Methods: This 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.

Results: VIR-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.

Conclusions: VIR-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.

Keywords: VIR-2482; influenza A; monoclonal antibody; phase 2 clinical trial; seasonal influenza prevention.

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Conflict of interest statement

Potential conflicts of interest. S. K. T., D. C., D. P., M. L. A., K. B., W. W. Y., and P. S. P. are employees of Vir Biotechnology, Inc and report stock ownership in Vir Biotechnology, Inc. C. M. H. is a former employee and shareholder of Vir Biotechnology, Inc. and is a coauthor on select Vir Biotechnology, Inc. patents. J. M. and M. D. have nothing to disclose. C. F. reports receiving grant support from Vir Biotechnology, Inc. for conduct of the clinical trial. F. G. H. has received consulting fees from The University of Alabama and Krog Associates; served as a nonpaid consultant to Vir Biotechnology, Inc. and other companies involved in developing influenza therapeutics or vaccines, including Appili, Arcturus, Eradivir, Gilead, GSK, Janssen/JNJ, Fujifilm, Merck, Ridgeback, Roche/Genentech, Sanofi Pasteur, and Via Nova; is a trustee of the International Society for Influenza and other Respiratory Viruses; and has participated on a data safety monitoring board or advisory board for Imperial College London, University of Oxford, and Enanta. Cidara, Enanta, Shionogi, and Versatope have made charitable donations for Dr. Hayden's consulting time, and both Shionogi and Roche have provided meeting travel support. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Graphical Abstract
Graphical Abstract
This graphical abstract is also available at Tidbit: https://tidbitapp.io/tidbits/a-randomized-placebo-controlled-trial-to-evaluate-the-safety-and-efficacy-of-vir-2482-in-healthy-adults-for-prevention-of-influenza-a-illness-peninsula-5591c84c-e394-4788-af48-4b317660ef10?utm_campaign=tidbitlinkshare&utm_source=ITP
Figure 1.
Figure 1.
Participant disposition. Based on efficacy findings, the study was terminated early and follow-up into the second influenza season did not take place.
Figure 2.
Figure 2.
Pharmacokinetic profiles of VIR-2482 following intramuscular administration of (A) 450 mg and (B) 1200 mg doses.Abbreviation: NPS, nasopharyngeal swab.
See this image and copyright information in PMC

References

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