• Vaccine Name: H56:IC31
• Target Pathogen: Mycobacterium tuberculosis
• Target Disease: Tuberculosis
• Type: Subunit vaccine
• Status: Clinical trial
• Host Species for Licensed Use: Human
• Antigen: H56 is a recombinant fusion protein composed of Ag85B, ESAT-6 and Rv2660c (Tait et al., 2024).
• Ag85B from M. tuberculosis H37Rv gene engineering:
  • Type: Fusion Protein
  • Description: This is use in fusion protein preparation (Tait et al., 2024).
  • Detailed Gene Information: Click Here.
• EsxA (ESAT-6) gene engineering:
  • Type: Fusion Protein
  • Description: This is use in fusion protein preparation (Tait et al., 2024).
  • Detailed Gene Information: Click Here.
• Rv2660c gene engineering:
  • Type: Fusion Protein
  • Description: This is use in fusion protein preparation (Tait et al., 2024).
  • Detailed Gene Information: Click Here.
• Preservative: H56 is a recombinant fusion protein composed of Ag85B, ESAT-6, and Rv2660c that was manufactured under GMP conditions and formulated with the IC31 adjuvant, which consists of a synthetic cationic peptide (KLK) and an immunostimulatory oligodeoxynucleotide (ODN1a), prior to intramuscular administration (Tait et al., 2024).
• Immunization Route: Intramuscular injection (i.m.)

Human Response

• Vaccination Protocol: Adults recently treated for drug-susceptible pulmonary tuberculosis received two intramuscular injections of 5 µg H56 formulated with 500 nmol IC31, administered on Day 0 and Day 56, with follow-up visits conducted to assess safety and immunogenicity up to several months after the second dose (Tait et al., 2024).
• Immune Response: The vaccine induced strong antigen-specific CD4? T-cell responses characterized by IFN-? production, with ESAT-6 being immunodominant, and generated measurable H56-specific IgG antibody responses (Tait et al., 2024).
• Side Effects: H56:IC31 was generally well tolerated, with mostly mild to moderate local reactions such as injection site pain, swelling, and redness, and no serious vaccine-related adverse events were reported (Tait et al., 2024).