Drug intelligence / Profile preview

AERAS-456

Development stage
Phase 2
Lead developer
Statens Serum Institut
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

AERAS-456 (H56:IC31) is a recombinant subunit vaccine candidate developed for the prevention and adjunctive treatment of tuberculosis (TB). It was created through a collaboration between the Statens Serum Institut (SSI) and Aeras, utilizing the IC31 adjuvant technology from Valneva. The vaccine is composed of the H56 fusion protein—which integrates three *Mycobacterium tuberculosis* antigens: Ag85B, ESAT-6, and Rv2660c—formulated with the IC31 adjuvant. Ag85B and ESAT-6 are early-stage antigens associated with active bacterial replication, while Rv2660c is a latency-associated antigen, enabling the vaccine to target the pathogen across its entire lifecycle. The IC31 adjuvant consists of a cationic antimicrobial peptide (KLK) and a synthetic oligodeoxynucleotide (dIdC), the latter of which acts as a TLR9 agonist to promote a robust Th1-polarized immune response. AERAS-456 has been evaluated in Phase I and Phase II clinical trials for its safety and immunogenicity in healthy individuals, patients with latent TB, and those who have recently completed treatment for active pulmonary TB.

Other names
H56 vaccineH-56 vaccineH 56 vaccineH56+IC31H56 subunit vaccineH-56 subunit vaccineH 56 subunit vaccine
02

Targets

ESAT-6 (Early secretory antigenic target 6)TLR9 (Toll-like receptor 9)Rv2660c (Mycobacterium tuberculosis Rv2660c)Ag85B (Antigen 85B)

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