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H4:IC31
- Development stage
- Phase 2
- Lead developer
- International AIDS Vaccine Initiative
- Modality
- Recombinant Proteins and Enzymes, Liposomes → Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems, Vaccines & Immunotherapeutics
- Administration
- Intramuscular
01
Overview
H4:IC31 is an investigational subunit vaccine candidate developed for the prevention of tuberculosis (TB). It consists of a recombinant fusion protein (H4) that combines two immunodominant mycobacterial antigens, Ag85B and TB10.4, formulated with the IC31 adjuvant. The IC31 adjuvant is composed of a synthetic cationic peptide (KLK) and an oligodeoxynucleotide (ODN1a), which acts as a Toll-like receptor 9 (TLR9) ligand. The vaccine aims to induce robust antigen-specific CD4+ T cell responses, particularly multifunctional Th1-type responses characterized by IFN-γ, TNF-α, and IL-2 production. Clinical trials in BCG-vaccinated but Mycobacterium tuberculosis-uninfected individuals have shown that H4:IC31 has an acceptable safety profile and is immunogenic[1][2][3][5][6].
- Other names
- H4:IC31HyVac4HyVac-4HyVac 4
02
Targets
TLR9 (Toll-like receptor 9)CD4+ T-cell receptor complex recognizing Mycobacterium tuberculosis Antigen 85B epitopesCD4+ T-cell receptor complex specific for Mycobacterium tuberculosis TB10.4 epitopes
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