Claims for Patent: 9,409,956

Summary for Patent: 9,409,956

Title:	Salmonella typhi Ty21a expressing Yersinia pestis F1-V fusion protein and uses thereof
Abstract:	Described herein is the generation of a plasmid construct for expression of a Yersinia pestis F1-V fusion protein. In the disclosed plasmid, the F1-V fusion protein coding sequence is operably linked to the E. coli htrA promoter, and is fused in-frame to the E. coli HlyA secretion signal sequence. Also described is Salmonella enterica serovar Typhi strain Ty21a containing the F1-V fusion protein expression plasmid, such as for use as an oral vaccine against plague.
Inventor(s):	Kopecko; Dennis J. (Silver Spring, MD), Osorio; Manuel (Bethesda, MD), Foote; Monica R. (North Potomac, MD)
Assignee:	The United States of America, as represented by the Secretary, Department of Health and Human Services (Washington, DC)
Application Number:	14/402,457
Patent Claims:	1. A recombinant nucleic acid molecule comprising a Y. pestis F1-V fusion protein coding sequence operably linked to an E. coli htrA promoter sequence, and further comprising an E. coli HlyA secretion signal peptide secretion signal peptide coding sequence fused in-frame with the F1-V fusion protein coding sequence, wherein the sequence of the nucleic acid molecule comprises SEQ ID NO: 1. 2. A plasmid comprising the recombinant nucleic acid molecule of claim 1, an origin of replication, a selectable marker and the E. coli HlyB and HlyD protein coding sequences. 3. A plasmid comprising the recombinant nucleic acid molecule of claim 1. 4. A recombinant nucleic acid molecule comprising a Yersinia pestis F1-V fusion protein coding sequence operably linked to an Escherichia coli htrA promoter sequence, wherein the nucleic acid molecule comprises a sequence at least 95% identical to nucleotides 1-1558 of SEQ ID NO: 1. 5. The recombinant nucleic acid molecule of claim 4, wherein the nucleic acid molecule comprises the sequence of nucleotides 1-1558 of SEQ ID NO: 1. 6. The recombinant nucleic acid molecule of claim 4, further comprising a secretion signal peptide coding sequence fused in-frame with the F1-V fusion protein coding sequence. 7. The recombinant nucleic acid molecule of claim 6, wherein the secretion signal peptide is the E. coli HlyA secretion signal peptide. 8. The recombinant nucleic acid molecule of claim 6, wherein the sequence of the nucleic acid molecule is at least 95% identical to SEQ ID NO: 1. 9. A plasmid comprising the recombinant nucleic acid molecule of claim 4. 10. The plasmid of claim 9, wherein the plasmid is a low-copy number plasmid. 11. The plasmid of claim 9, further comprising a selectable marker. 12. The plasmid of claim 11, wherein the selectable marker is an antibiotic resistance gene. 13. The plasmid of claim 9, further comprising the E. coli HlyB and HlyD protein coding sequences. 14. A Salmonella Typhi Ty21a bacterium comprising the recombinant nucleic acid molecule of claim 4. 15. An immunogenic composition comprising the Salmonella Typhi Ty21a bacterium of claim 14 and a pharmaceutically acceptable carrier. 16. The immunogenic composition of claim 15, wherein the composition is formulated for oral administration. 17. A method of eliciting an immune response against Yersinia pestis in a subject, comprising administering to the subject the Salmonella Typhi Ty21a bacterium of claim 14. 18. The method of claim 17, wherein the immune response is a protective immune response. 19. A method of reducing the risk of developing plague or treating plague in a subject, comprising administering to the subject the Salmonella Typhi Ty21a of claim 14.

Details for Patent 9,409,956

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emergent Travel Health, Inc.	VIVOTIF	typhoid vaccine live oral ty21a	Capsule	103123	12/15/1989		2032-05-23