• Vaccine Name: Spore-FP1
• Target Pathogen: Mycobacterium tuberculosis
• Target Disease: Tuberculosis
• Type: Subunit vaccine
• Status: Research
• Host Species for Licensed Use: Pig
• Antigen: The antigen is a fusion protein composed of Ag85B, Acr (HspX) and HBHA heparin-binding domain (short 6 kDa N-terminal domain) (White et al., 2023).
• Ag85B from M. tuberculosis H37Rv gene engineering:
  • Type: Fusion Protein
  • Description: This is use in fusion protein preparation (White et al., 2023).
  • Detailed Gene Information: Click Here.
• hspX gene engineering:
  • Type: Fusion Protein
  • Description: This is use in fusion protein preparation (White et al., 2023).
  • Detailed Gene Information: Click Here.
• HBHA gene engineering:
  • Type: Fusion Protein
  • Description: This is use in fusion protein preparation (White et al., 2023).
  • Detailed Gene Information: Click Here.
• Adjuvant: poly(I:C) vaccine adjuvant
  • Adjuvant name: poly(I:C) vaccine adjuvant
  • VO adjuvant ID: VO_0001332
  • Description: Poly(I:C) promote strong immune response in Spore-FP1 vaccine (White et al., 2023).
• Preparation: The FP1 fusion protein is adsorbed onto heat-inactivated Bacillus subtilis spores and formulated with PolyI:C in sterile saline (White et al., 2023).
• Immunization Route: subcutaneous injection

Pig Response

• Vaccination Protocol: Guinea pigs were first primed subcutaneously with either Spore-FP1 or BCG. For the booster regimen, Spore-FP1 was administered intranasally at later time points following the prime immunization. In the BCG prime–boost group, animals received a single subcutaneous BCG vaccination followed by intranasal boosts with Spore-FP1 before aerosol challenge (White et al., 2023).
• Immune Response: Vaccinated guinea pigs showed enhanced antigen-specific immune responses associated with reduced granuloma formation, decreased lung pathology, and lower bacterial loads compared with controls (White et al., 2023).
• Challenge Protocol: Four weeks after the final immunization, guinea pigs were challenged with low-dose aerosol Mycobacterium tuberculosis H37Rv, and bacterial burden in lungs and spleen was assessed (White et al., 2023).
• Efficacy: Spore-FP1 significantly reduced lung bacterial burden and tissue pathology compared with controls and improved protection when used as a BCG booster (White et al., 2023).