ArticleOpen forum infectious diseases2022
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of the Monoclonal Antibody MHAA4549A in Patients With Acute Uncomplicated Influenza A Infection.
Article in Open forum infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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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.
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Who cites it
15 citing papers in PubMed, 15 citations in OpenAlex.
- 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 · 2024Trial
- 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.Antimicrobial agents and chemotherapy · 2024Trial
- Nonclinical investigation of the potential of MHAA4549A, an anti-influenza A therapeutic antibody, to mediate antibody-dependent enhancement.Toxicological sciences : an official journal of the Society of Toxicology · 2026Article
- A C-type single-domain antibody with protective efficacy against H1N1 via respiratory administration.Virologica Sinica · 2026Article
- Influenza virus research in an era of emerging respiratory threats: host-virus interactions, surveillance technologies, antiviral management and resistance, and vaccine preparedness.Frontiers in microbiology · 2026Review
- Pre-existing cross-reactive immunity to highly pathogenic avian influenza 2.3.4.4b A(H5N1) virus in the United States.Nature communications · 2025Article
- Polyclonal and Monoclonal Antibodies for the Treatment and Prevention of Influenza.The Journal of infectious diseases · 2025Review
- Non-neutralizing antibodies to influenza A matrix-protein-2-ectodomain are broadly effective therapeutics and resistant to viral escape mutations.Science advances · 2025Article
- Structural convergence and water-mediated substrate mimicry enable broad neuraminidase inhibition by human antibodies.Nature communications · 2025Article
- Passive Immunization in the Prevention and Treatment of Viral Infections.European journal of immunology · 2025Review
- An intranasally administered IgM protects against antigenically distinct subtypes of influenza A viruses.Nature communications · 2025Article
- Antiviral strategies against influenza virus: an update on approved and innovative therapeutic approaches.Cellular and molecular life sciences : CMLS · 2025Review
- Monoclonal antibodies against influenza viruses: a clinical trials review.Frontiers in immunology · 2025Review
- Influenza antivirals and their role in pandemic preparedness.Antiviral research · 2023Review
- Evolution of Influenza Viruses-Drug Resistance, Treatment Options, and Prospects.International journal of molecular sciences · 2022Review
Corrections and comments
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Authors and funding
13 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMHAA4549A, a human monoclonal antibody targeting the influenza A hemagglutinin stalk, neutralizes influenza A virus in animal and human volunteer challenge studies. We investigated the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A in outpatients with acute, uncomplicated influenza A infection.
methodsThis was a phase 2, randomized, double-blind, placebo-controlled trial of single intravenous (IV) doses of 3600 mg or 8400 mg of MHAA4549A or IV placebo in adult outpatients testing positive for influenza A. Patients were enrolled across 35 sites in 6 countries. Randomization and dosing occurred within ≤72 hours of symptom onset; the study duration was 14 weeks. The primary end point was the nature and frequency of adverse events (AEs). Secondary end points included median time to alleviation of all influenza symptoms, effects on nasopharyngeal viral load and duration of viral shedding, and MHAA4549A serum pharmacokinetics.
resultsOf 125 randomized patients, 124 received study treatment, with 99 confirmed positive for influenza A by central testing. The frequency of AEs between the MHAA4549A and placebo groups was similar; nausea was most common (8 patients; 6.5%). MHAA4549A serum exposure was confirmed in all MHAA4549A-treated patients and was dose-proportional. No hospitalizations or deaths occurred. Between the MHAA4549A and placebo groups, no statistically significant differences occurred in the median time to alleviation of all symptoms, nasopharyngeal viral load, or duration of viral shedding.
conclusionsWhile MHAA4549A was safe and well tolerated with confirmed exposure, the antibody did not improve clinical outcomes in patients with acute uncomplicated influenza A infection.
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