Stage of Development

Proof of Concept – Animal Model

Vaccine Platform

Protein / Adjuvant

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

Immune ResponseB-cell/Antibody
T-cell phenotypeCD4
T-cell functional profileIFN-γ
B-cell/antibody characteristicsMucosal IgA antibodies
Preferential immune tissue localizationLung
Trained immunityYes

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