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CAF01 is a clinical-stage cationic liposomal adjuvant system developed by the Statens Serum Institut (SSI). It is composed of the cationic lipid dimethyl-dioctadecylammonium (DDA) bromide and the synthetic cord factor trehalose-6,6'-dibehenate (TDB). CAF01 functions as a delivery system that forms a depot at the injection site while simultaneously acting as an immunomodulator. The TDB component is a potent agonist of the macrophage-inducible C-type lectin (Mincle) receptor, which triggers the innate immune system to drive the differentiation of Th1 and Th17 cell-mediated immunity and robust antibody responses. This adjuvant has been evaluated in human clinical trials for vaccines targeting tuberculosis, HIV-1, and Chlamydia trachomatis, and has shown a favorable safety profile and strong immunogenicity.
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