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Ag85B-ESAT-6 + CAF01 is a subunit tuberculosis (TB) vaccine candidate composed of a recombinant fusion protein antigen (Ag85B fused to ESAT-6 from Mycobacterium tuberculosis) formulated with the liposomal adjuvant system CAF01. The combination is designed to induce strong and long-lasting cellular immune responses, particularly Th1-type immunity characterized by IFN-gamma production and antigen-specific CD4+ T-cell activation. The adjuvant CAF01 enhances the immunogenicity of the protein antigen by promoting robust T-cell responses necessary for protection against TB. Clinical studies have shown that this formulation is safe and well-tolerated in humans, eliciting persistent memory T-cell responses without significant adverse effects. Developed primarily for prevention of tuberculosis infection or disease progression, it has been evaluated in both preclinical models and early-phase human clinical trials[2][3][4].
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