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H56 + IC31
- Development stage
- Unknown
- Lead developer
- Statens Serum Institut
- Modality
- Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Administration
- Intramuscular
01
Overview
H56 + IC31 (AERAS-456) is a recombinant protein subunit vaccine candidate developed by the Statens Serum Institute (SSI) and Aeras for the prevention and treatment of tuberculosis (TB). The vaccine is composed of the H56 fusion protein, which combines three Mycobacterium tuberculosis antigens: Ag85B and ESAT-6 (associated with active infection) and Rv2660c (a latency-associated protein). This antigen component is formulated with the IC31 adjuvant system, which consists of a cationic antimicrobial peptide (KLK) and a synthetic toll-like receptor 9 (TLR9) agonist oligonucleotide (ODN1a). The vaccine is designed to elicit a robust Th1-type cell-mediated immune response to protect against initial TB infection, prevent the reactivation of latent TB, and potentially serve as a therapeutic adjunct. It has been evaluated in Phase I and Phase IIa clinical trials for safety and immunogenicity in HIV-negative adults.
- Brand names
- AERAS-456AERAS456AERAS 456
- Other names
- H56:IC31H56/IC31
02
Targets
TLR9 (Toll-like receptor 9)Rv2660c (Mycobacterium tuberculosis Rv2660c)ESAT-6 (Early secretory antigenic target 6)Ag85B (Antigen 85B)
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