Advances in clinical immunogenicity evaluation of influenza vaccines

Influenza vaccination is an effective intervention for preventing severe influenza, and assessing its immunogenicity is a critical step in determining vaccine protective efficacy. With the widespread use of influenza vaccines-including split-virion, subunit, recombinant protein, and live attenuated formulations-methods for evaluating immunogenicity have grown increasingly diverse and complex. This article systematically examines the advantages and limitations of various immunogenicity assessment approaches for influenza vaccines. It draws upon multidimensional evaluation frameworks covering humoral, cellular, and mucosal immunity, incorporating analytical techniques such as hemagglutination inhibition assays, microneutralization assays, enzyme-linked immunosorbent assays, mucosal secretory IgA detection, enzyme-linked immunospot assays, and flow cytometry. Furthermore, clinical challenge trials evaluations play an essential role in elucidating the relationship between immunogenicity and protective efficacy. This paper aims to establish a systematic and comprehensive reference framework for the development and immunogenicity evaluation of influenza vaccines, thereby advancing vaccine design and the prediction of protective outcomes toward greater precision.