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SP0335 is an inactivated, adjuvanted vaccine candidate developed by Sanofi (Sanofi Pasteur) for pandemic preparedness against H5 subtype influenza A viruses. As a monovalent vaccine, it is designed to provide protection against avian influenza strains with pandemic potential, such as H5N1. The vaccine utilizes an inactivated virus platform, which presents killed virus particles to the immune system to stimulate a protective response without the risk of infection. To enhance immunogenicity, particularly in populations with little to no pre-existing immunity to the H5 antigen, the vaccine is formulated with an adjuvant (typically an oil-in-water emulsion like AF03). SP0335 is currently in Phase 2 clinical development, where it is being evaluated for its safety, tolerability, and ability to induce neutralizing antibodies against the H5 hemagglutinin protein.
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