International journal of antimicrobial agents · 2026
Prophylactic and therapeutic efficacy of monoclonal antibodies against avian influenza H5N1 virus.
СтатьяОбзорНазвание и аннотация: Перевод в очереди
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Panagiotopoulos Antonios-Periklis, Anastassopoulou Cleo, Ranellou Kyriaki, Mariolis Ilias, Tsakris Athanasios
Аннотация
OBJECTIVES: Highly pathogenic avian influenza H5N1 continues to pose a serious zoonotic and pandemic threat due to its increasing cross-species transmission and high virulence in humans. Despite the availability of vaccines and antivirals for seasonal influenza, effective prophylactic and treatment options for H5N1 remain limited. Herein we explore the potential action of monoclonal antibodies (mAbs) against H5N1, focusing on those with demonstrated efficacy in animal models.
METHODS: A literature search of PubMed, Scopus, and ClinicalTrials.gov was conducted for studies published during 2005-2025 using the terms (H5N1 avian influenza OR highly pathogenic avian influenza) AND (monoclonal antibody OR broadly neutralizing antibody).
RESULTS: Most identified mAbs target conserved hemagglutinin epitopes and function as broad neutralizing fusion/entry inhibitors. Other mAbs prevent viral release by targeting neuraminidase, and those directed against the M2 ectodomain and nucleoprotein function through Fc receptor-mediated pathways. These mAbs have shown robust protection against lethal H5N1 challenge in mice, ferrets, and/or non-human primates. Compounds such as CR6261, MED18852, and TCN-032 have been evaluated in clinical trials for seasonal influenza, yielding encouraging safety and pharmacokinetics results and no resistance emergence. Despite these positive results, their clinical development was prematurely discontinued.
CONCLUSIONS: Integrating these highly effective mAbs into our H5N1 pandemic preparedness arsenal is a logical next step to provide a robust prophylactic and therapeutic option at the early stages of an outbreak. Addressing regulatory and logistical barriers, invest in stockpiling and emergency use protocols and supporting adaptive clinical trial frameworks will be critical for their future use.
METHODS: A literature search of PubMed, Scopus, and ClinicalTrials.gov was conducted for studies published during 2005-2025 using the terms (H5N1 avian influenza OR highly pathogenic avian influenza) AND (monoclonal antibody OR broadly neutralizing antibody).
RESULTS: Most identified mAbs target conserved hemagglutinin epitopes and function as broad neutralizing fusion/entry inhibitors. Other mAbs prevent viral release by targeting neuraminidase, and those directed against the M2 ectodomain and nucleoprotein function through Fc receptor-mediated pathways. These mAbs have shown robust protection against lethal H5N1 challenge in mice, ferrets, and/or non-human primates. Compounds such as CR6261, MED18852, and TCN-032 have been evaluated in clinical trials for seasonal influenza, yielding encouraging safety and pharmacokinetics results and no resistance emergence. Despite these positive results, their clinical development was prematurely discontinued.
CONCLUSIONS: Integrating these highly effective mAbs into our H5N1 pandemic preparedness arsenal is a logical next step to provide a robust prophylactic and therapeutic option at the early stages of an outbreak. Addressing regulatory and logistical barriers, invest in stockpiling and emergency use protocols and supporting adaptive clinical trial frameworks will be critical for their future use.