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The H5N1 pandemic influenza whole-virion inactivated vaccine is a monovalent vaccine candidate developed by the Wuhan Institute of Biological Products (WIBP) to provide protection against the highly pathogenic avian influenza (HPAI) H5N1 virus. The vaccine is produced using the NIBRG-14 strain, which is a high-yield reassortant virus derived from the A/Vietnam/1194/2004 strain via reverse genetics. As a whole-virion inactivated vaccine, it contains the entire virus particle that has been rendered non-infectious, typically through chemical inactivation with agents such as formaldehyde. This modality is often more immunogenic than split-virion or subunit vaccines because the intact virion contains viral RNA and other structural components that can act as endogenous adjuvants by stimulating Toll-like receptors (TLRs). Clinical trials, including Phase I studies in healthy volunteers, have evaluated the safety and immunogenicity of the vaccine at various dose levels, measuring its ability to elicit hemagglutination-inhibition (HI) and neutralizing antibody responses.
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