• Vaccine Name: H4-IC31
• Target Pathogen: Mycobacterium tuberculosis
• Target Disease: Tuberculosis
• Type: Subunit vaccine
• Status: Clinical trial
• Host Species for Licensed Use: Human
• Antigen: H4 fusion protein composed of Ag85B and TB10.4 from Mycobacterium tuberculosis (Rozot et al., 2020).
• Ag85B from M. tuberculosis H37Rv gene engineering:
  • Type: Fusion Protein
  • Description: This is use in fusion protein preparation (Ming et al., 2019).
  • Detailed Gene Information: Click Here.
• esxH gene engineering:
  • Type: Fusion Protein
  • Description: This is use in fusion protein preparation (Rozot et al., 2020).
  • Detailed Gene Information: Click Here.
• Preparation: The vaccine is prepared by formulating the recombinant H4 fusion protein (Ag85B–TB10.4) with the IC31 adjuvant.
  Each dose contained 15 μg of H4 protein combined with 500 nmol of IC31 and was administered under controlled clinical trial conditions (Rozot et al., 2020).
• Immunization Route: Intramuscular injection (i.m.)

Human Response

• Vaccination Protocol: Participants received intramuscular injections of the H4:IC31 vaccine. The vaccination schedule consisted of two doses administered on day 0 and day 56. Each dose contained 15 ?g of H4 fusion protein formulated with 500 nmol of IC31 adjuvant (Rozot et al., 2020).
• Description: H4:IC31 induced strong Th1-biased cellular immune responses and showed a trend toward protection against sustained M. tuberculosis infection; however, protective efficacy did not reach statistical significance (Rozot et al., 2020).