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Ag85B-ESAT-6 + IC31

Development stage
Phase 1
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 + IC31 is a subunit vaccine candidate for tuberculosis (TB) composed of a recombinant fusion protein (Ag85B fused to ESAT-6) formulated with the novel adjuvant IC31. The vaccine is designed to induce strong and long-lasting T cell-mediated immune responses against Mycobacterium tuberculosis. Ag85B and ESAT-6 are immunodominant antigens from M. tuberculosis that stimulate Th1-type cellular immunity characterized by interferon-gamma production, which is critical for protection against TB. The addition of the IC31 adjuvant enhances these antigen-specific T cell responses and promotes durable memory immunity. Clinical studies have shown that this combination elicits robust antigen-specific CD4+ T cell responses in both mycobacterially naïve individuals and those previously vaccinated with BCG or latently infected with TB, with minimal adverse effects limited mainly to transient soreness at the injection site[1][2][3]. The primary indication under investigation is prevention of pulmonary tuberculosis.

Other names
Ag85B–ESAT–6 adjuvanted with IC31Ag85B-ESAT-6/IC31H1/IC31
02

Targets

TLR9 (Toll-like receptor 9)Major histocompatibility complex class II – T cell receptor complex (MHC II-TCR complex)

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