Claims for Patent: 8,105,613

Summary for Patent: 8,105,613

Title:	Vaccine formulation
Abstract:	Spore coat-associated proteins from members of Bacillus genera, and in particular spore-coat associated protein N (CotN), have utilization as adjuvants in vaccine formulations. The vaccine formulations most likely contain a virulence factor of bacterial origin, which in the case of Bacillus genera is the protective antigen.
Inventor(s):	Flick-Smith; Helen Claire (Salisbury, GB), Eyles; James Edward (Salisbury, GB), Waters; Emma Louise (Salisbury, GB), Walker; Nicola Jane (Salisbury, GB), Williamson; Ethel Diane (Salisbury, GB), Baillie; Leslie William (Salisbury, GB), Miller; Julie (Salisbury, GB)
Assignee:	The Secretary of State for Defence (GB)
Application Number:	11/886,170
Patent Claims:	1. A vaccine formulation comprising an antigen and an adjuvant comprising an isolated spore coat-associated protein from a member of Bacillus genera. 2. The vaccine formulation of claim 1, wherein the member of Bacillus genera is Bacillus cereus or Bacillus anthracis. 3. The vaccine formulation of claim 1, wherein the vaccine formulation is a live attenuated vaccine, or an inactivated vaccine. 4. The vaccine formulation of claim 1, wherein the vaccine formulation is a subunit vaccine. 5. The vaccine formulation of claim 1, wherein the antigen is a Bacillus virulence factor protein. 6. The vaccine formulation of claim 5, wherein the virulence factor protein is Bacillus anthracis protein. 7. The vaccine formulation of claim 6, wherein the antigen is an isolated Bacillus anthracis protective antigen protein. 8. The vaccine formulation of claim 7, wherein the antigen is a recombinant Bacillus anthracis protective antigen protein. 9. The vaccine formulation of claim 1, wherein at least one of the antigen or the adjuvant is microencapsulated. 10. The vaccine formulation of claim 1, wherein the vaccine formulation is in a form suitable for administration by the intra-nasal route. 11. The vaccine formulation of claim 1, wherein the dose of adjuvant is of from about 1 ng to 100 .mu.g, 100 ng to 10 .mu.g, 1 ng to 1 mg, or 100 ng to 100 .mu.g. 12. The vaccine formulation of claim 1, wherein the isolated spore coat-associated protein is spore coat-associated protein N (Cot N). 13. The vaccine formulation of claim 12, wherein the isolated spore-coat associated protein is Bacillus anthracis spore-coat associated protein N (CotN). 14. The vaccine formulation of claim 13, wherein the isolated spore-coat associated protein N (CotN) comprises SEQ ID NO:1. 15. The vaccine formulation of claim 13, wherein the isolated spore-associated protein N (CotN) is encoded by a nucleic acid comprising the nucleic acid sequence of SEQ ID NO:2. 16. A formulation for stimulating an immune response to an antigen in an individual comprising the antigen and an isolated spore coat-associated protein from a member of Bacillus genera in an amount capable of enhancing the immune response to the antigen in the individual when the formulation is administered to the individual. 17. A formulation for stimulating an immune response to an antigen in an individual comprising an antigen and an isolated spore coat-associated protein from a member of Bacillus genera in an amount capable of eliciting antibody titers to the antigen in the individual when the formulation is administered to the individual comparable to or higher than antibody titers seen when the antigen is administered with an adjuvant amount of cholera toxin. 18. A formulation for stimulating an immune response to an antigen in an individual comprising the antigen and an adjuvant amount of an isolated spore coat-associated protein from a member of Bacillus genera. 19. A method of stimulating an immune response in an individual comprising administering to the individual a vaccine formulation of claim 1. 20. A method of stimulating an immune response to anthrax infection comprising administration to an individual a vaccine formulation of claim 16.

Details for Patent 8,105,613

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	11/12/1998		2025-03-10