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The H5N1 monovalent influenza vaccine is an investigational inactivated whole-virus vaccine adjuvanted with aluminum phosphate gel (AlPO4). Manufactured by Fluart Innovative Vaccines Ltd., it targets the H5N1 avian influenza strain (hemagglutinin subtype H5, neuraminidase subtype N1). In clinical development, specifically in a Phase IIb trial (EudraCT 2015-001979-46) sponsored by BiondVax Pharmaceuticals, it was utilized as a booster component in a prime-boost strategy following priming with the universal influenza vaccine candidate Multimeric-001 (M-001). The vaccine is designed to elicit protective immune responses against pandemic-potential avian influenza by presenting conserved and strain-specific epitopes to the immune system. Clinical studies have evaluated its immunogenicity at suboptimal doses (e.g., 3 μg) to demonstrate the dose-sparing potential of universal primers.
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