Develop functional assays that are fit for clinical trial purpose to accurately capture the breadth and range of protective responses other than virus neutralization, such as influenza virus–specific ADCC, antibody-dependent cellular phagocytosis, and complement dependent cytotoxicity.
de Vries 2023 compiled ADCC data obtained in four separate studies to get a comprehensive overview of the induction of ADCC-mediating Abs after influenza virus infection, or immunization with monovalent, trivalent, or quadrivalent influenza vaccines.
Chen 2022 developed four novel cell-based assays to assess ADCC antibodies against HA or NA proteins to assess the contribution of ADCC antibody to vaccine immunogenicity.
Meade 2023 used influenza virus protein microarray technology to measure Ab responses (to group 1 and 2 HAs and influenza B HAs) induced by universal influenza vaccine cHA constructs in phase 1 clinical trials, showing that cHA vaccines induce very broad cross-subtype Ab responses.
Waerlop 2022 (FLUCOP Consortium) described the harmonization and qualification of the influenza-specific interferon-gamma ELISpot assay to detect and qualify vaccine-induced cellular immune responses.
Bernard 2022 (FLUCOP Consortium) validated a harmonized ELLA-NA Inhibition (NI) SOP for N1 influenza antigen (providing a publicly available SOP for ELLA-NI), tested the SOP with NA from IBVs, showed the assay performed consistently with both IAV and IBV antigens, and demonstrated that recombinant NA could be used as a source of antigen in ELLA-NI.
Cheung 2022 developed two ELISA-based potency assays for group 1 influenza A viruses using cross-reactive nanobodies.