2017
DOI: 10.1128/aac.01154-17
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Phase 2 Randomized Trial of the Safety and Efficacy of MHAA4549A, a Broadly Neutralizing Monoclonal Antibody, in a Human Influenza A Virus Challenge Model

Abstract: MHAA4549A, a human monoclonal antibody targeting the hemagglutinin stalk region of influenza A virus (IAV), is being developed as a therapeutic for patients hospitalized with severe IAV infection. The safety and efficacy of MHAA4549A were assessed in a randomized, double-blind, placebo-controlled, dose-ranging study in a human IAV challenge model. One hundred healthy volunteers were inoculated with A/Wisconsin/67/2005 (H3N2) IAV and, 24 to 36 h later, administered a single intravenous dose of either placebo, M… Show more

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Cited by 62 publications
(61 citation statements)
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References 28 publications
(39 reference statements)
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“…Short duration proof of concept studies, which incorporate the HVC model, typically include small numbers of subjects. The resulting safety and, particularly, efficacy data can more accurately guide decisions on whether to expose a larger number of subjects to promising candidate therapeutics in field studies than conventional phase 1 safety data alone otherwise might protein [155,156] the conserved stalk of the HA [157] and small molecule antiviral drugs that target the viral polymerase, e.g. favipiravir [158].…”
Section: The Hvc Model and Influenzamentioning
confidence: 99%
“…Short duration proof of concept studies, which incorporate the HVC model, typically include small numbers of subjects. The resulting safety and, particularly, efficacy data can more accurately guide decisions on whether to expose a larger number of subjects to promising candidate therapeutics in field studies than conventional phase 1 safety data alone otherwise might protein [155,156] the conserved stalk of the HA [157] and small molecule antiviral drugs that target the viral polymerase, e.g. favipiravir [158].…”
Section: The Hvc Model and Influenzamentioning
confidence: 99%
“…Although detection of viruses that exhibit reduced susceptibility to NA inhibitors or baloxavir marboxil in immunocompetent patients has frequently been reported 1,[4][5][6][7][8][9] , such viruses usually do not dominate susceptible viruses with the exception of the worldwide spread of oseltamivir-resistant H1N1 virus in the 2007-2008 season. Recently, broadly protective human monoclonal antibodies (mAbs) against conserved regions of HA, including the receptorbinding site (RBS) and stem region, have been evaluated [10][11][12][13][14][15][16] and studies for their clinical application are being conducted [17][18][19][20] . However, no human mAbs are currently available for clinical use.…”
mentioning
confidence: 99%
“…MHAA4549A is a human immunoglobulin G1 (IgG1) monoclonal antibody that binds to a highly conserved epitope on the stalk of influenza A HA (Gupta et al, 2016). In a Phase 2 human influenza A virus challenge study MHAA4549A showed significant reduction in clinical symptoms and viral burden relative to placebo (McBride et al, 2017). Two additional Phase 2 randomized, double-blind, placebo-controlled trials for treatment of influenza A infection utilizing MHAA4549A were conducted.…”
Section: Updates On Clinical Trialsmentioning
confidence: 99%