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H5N1 vaccine + AS03 is an investigational avian influenza vaccine combination consisting of an H5N1 influenza antigen and the AS03 adjuvant system. AS03 is an oil-in-water emulsion adjuvant composed of squalene, DL-alpha-tocopherol, and polysorbate 80, designed to enhance the immune response to the vaccine antigen. This enhancement typically allows for dose-sparing (using less antigen per dose) and may improve cross-reactivity against different viral strains. The National Institute of Allergy and Infectious Diseases (NIAID) has sponsored clinical studies, including Phase 1/2 trials, to characterize the innate immune responses to this adjuvanted formulation compared to unadjuvanted versions in healthy adults. The vaccine is primarily intended to provide protection against highly pathogenic avian influenza (HPAI) H5N1 strains, which pose a significant pandemic threat.
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