Drug intelligence / Profile preview

Ag85B-ESAT-6 + CAF01

Development stage
Unknown
Lead developer
Statens Serum Institut
Modality
Recombinant Proteins and Enzymes, Liposomes → Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

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].

Other names
H1/CAF01TB subunit vaccine (Ag85B-ESAT-6 + CAF01)
02

Targets

MHC I (MHC class I})MHC II (Major histocompatibility complex class II receptor)TCR (T cell antigen receptor complex)

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