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H5 VLP vaccine + GLA-SE is a plant-derived virus-like particle (VLP) vaccine candidate developed by Medicago (a subsidiary of Mitsubishi Tanabe Pharma) for the prevention of H5N1 avian influenza. The vaccine consists of recombinant H5 hemagglutinin protein from the A/Indonesia/05/2005 strain, produced via transient expression in nontransgenic plants using an agrobacterial vector and assembled into VLPs. These particles mimic the structure of the influenza virus to induce a protective immune response without being infectious. The vaccine is co-administered with GLA-SE (glucopyranosyl lipid adjuvant-stable emulsion), a synthetic Toll-like receptor 4 (TLR4) agonist, which acts as an adjuvant to enhance the magnitude and quality of the immune response. Phase 2 clinical trials have demonstrated that low doses of the GLA-SE-adjuvanted vaccine can induce hemagglutination inhibition (HI) responses that meet regulatory criteria for pandemic vaccine licensure.
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