Spore-FP1
Candidate Overview
Spore-FP1 is a subunit vaccine candidate consisting of inactivated Bacillus subtilis spores coated with the FP1 fusion protein and formulated with Poly(I:C) adjuvant. FP1 fusion protein comprises Ag85B, Acr/HspX and the N-terminal domain of HBHA antigen. It is intended as a mucosal boost vaccine in BCG-immunised hosts.
Sponsor / Lead Developer: St George's University of London
Development partner(s): Sporegen LTD
Primary Indication: Prevention of Mtb infection or sustained infection
Other Indication(s): Prevention of TB disease
Target Population(s): Adolescents, Adults, Children, and People with Mtb infection
Target Route of Administration: Aerosol
Immune tissue localization: Lung
Immunological responses: B-cell/Antibody and T-cell
Preclinical Animal Models: Guinea pig, Mouse, and Nonhuman primate
Intended to elicit trained immunity: Yes
Additional Immunologic Response Information
HYPOTHESIZED | DEMONSTRATED |
|
| Immune Response | B-cell/Antibody T-cell |
|
| T-cell phenotype | CD4 CD8 |
|
| T-cell functional profile | IFN-γ TNF-α IL-17 |
|
| B-cell/antibody characteristics | Mucosal IgA antibodies | |
| Preferential immune tissue localization | Lung | |
| Trained immunity | Yes | |
Related Publications
Trial-specific publications are listed above with the clinical trial listing
- Mucosal and systemic immune responses after a single intranasal dose of nanoparticle and spore-based subunit vaccines in mice with pre-existing lung mycobacterial immunity (Front Immunol., 2023)
- Spore-FP1 tuberculosis mucosal vaccine candidate is highly protective in guinea pigs but fails to improve on BCG-conferred protection in non-human primates. (Front Immunol., 2023)
- Mucosal Delivery of Fusion Proteins with Bacillus subtilis Spores Enhances Protection against Tuberculosis by Bacillus Calmette-Guérin. (Front Immunol. 2018)
Mucosal vaccination against tuberculosis using inert bioparticles. (Infect Immun. 2013)
Additional Information
While the current formulation of Spore-FP1 incudes Poly(I:C) as the adjuvant, we would like to test it also with the ASO1 adjuvant