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LEISH-F3 + SE is an investigational protein subunit vaccine developed by the National Institute of Allergy and Infectious Diseases (NIAID) for the prevention or treatment of visceral leishmaniasis. The vaccine consists of the LEISH-F3 recombinant fusion protein, which combines two highly conserved Leishmania antigens: nucleoside hydrolase (NH) and sterol 24-c-methyltransferase (SMT). These antigens are formulated with a stable oil-in-water emulsion (SE) adjuvant, a squalene-based system designed to enhance immune responses. In clinical evaluations, the SE formulation serves as a baseline comparator to assess the safety and immunogenicity of the vaccine when used alone versus when combined with additional Toll-like receptor 4 (TLR4) agonists like GLA or MPL. The vaccine aims to elicit protective Th1-type T cell responses and IgG antibody production against the Leishmania parasites responsible for the most severe form of the disease.
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