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LEISH-F2 + MPL-SE is a second-generation recombinant protein vaccine developed for the treatment and prevention of leishmaniasis, particularly cutaneous leishmaniasis (CL) and post-kala-azar dermal leishmaniasis (PKDL). The vaccine consists of the LEISH-F2 antigen—a recombinant fusion protein derived from three conserved Leishmania antigens (thiol-specific antioxidant [TSA], stress-inducible protein 1 [LmSTI1], and elongation initiation factor [LeIF])—combined with the adjuvant monophosphoryl lipid A in a stable oil-in-water emulsion (MPL-SE). The mechanism of action involves immunostimulation, specifically activating T cell responses to induce protective immunity against Leishmania parasites. Clinical trials have demonstrated that this formulation is safe, well-tolerated, and capable of inducing strong cellular immune responses in humans. It has reached Phase 2 clinical development for cutaneous leishmaniasis[1][4][6].
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