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This is a combination immunotherapeutic or vaccine candidate composed of Leishmania antigens (typically heat-killed or soluble Leishmania parasite proteins) and recombinant human interleukin-12 (rhIL-12). The rationale for this combination is to enhance the immune response against Leishmania infection by promoting a strong Th1-type cellular immunity. IL-12 is a pro-inflammatory cytokine produced by macrophages and dendritic cells that stimulates T lymphocyte proliferation, promotes differentiation of CD4+ T cells into Th1 cells, increases IFN-gamma production from NK and T cells, and enhances cytotoxic activity. In preclinical primate models (rhesus macaques), vaccination with killed Leishmania antigens plus rhIL-12 (and often alum as an adjuvant) was safe and induced robust protective immunity against cutaneous leishmaniasis. The addition of rhIL-12 significantly augmented the antigen-specific IFN-gamma response after vaccination compared to controls[3][5][7]. This approach has been proposed as both a therapeutic adjunct and as part of vaccine strategies for various forms of leishmaniasis.
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