Claims for Patent: 8,071,113

Summary for Patent: 8,071,113

Title:	Live, oral vaccine for protection against Shigella dysenteriae serotype 1
Abstract:	The invention relates to Salmonella typhi Ty21a comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) the DNA sequence set out in any one of SEQ ID NOs: 1 and 2 and species homologs thereof; b) DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2, and species homologs thereof; and c) DNA encoding a O antigen biosynthesis gene product that hybridizes under moderately stringent conditions to the DNA of (a) or (b); and related sequences, compositions of matter, vaccines, methods of using, and methods of making.
Inventor(s):	Kopecko; Dennis J. (Silver Spring, MD), Xu; DeQi (Columbia, MD)
Assignee:	The United States of America as represented by the Department of Health and Human Services (Washington, DC) N/A (N/A)
Application Number:	11/597,301
Patent Claims:	1. Salmonella typhi Ty21a comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) the DNA sequence set out in any one of SEQ ID NOs: 1 and 2 and nucleic acid molecules from the species Shigella dysenteriae serotype 1 that share at least about 90% sequence identity with the nucleic acid molecule of SEQ ID NO:1 or 2; and b) DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2 and nucleic acid molecules from the species Shigella dysenteriae serotype 1 that share at least about 90% sequence identity with the nucleic acid molecule of SEQ ID NO:1 or 2. 2. The Salmonella typhi Ty21a of claim 1 comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) the DNA sequence set out in any one of SEQ ID NOs: 1 and 2; and b) DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2. 3. The Salmonella typhi Ty21a of claim 1 comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2. 4. The Salmonella typhi Ty21a of claim 1 comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of the DNA sequence set out in any one of SEQ ID NOs: 1 and 2. 5. The Salmonella typhi Ty21a of claim 1 comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) the DNA sequence set out in any one of SEQ ID NOs: 1 and 2; and b) DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2. 6. The Salmonella typhi Ty21a of claim 1 comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2. 7. The Salmonella typhi Ty21a of claim 1 comprising core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) the DNA sequence set out in any one of SEQ ID NOs: 1 and 2. 8. The Salmonella typhi Ty21a of claim 1, said DNA being present on a plasmid. 9. The Salmonella typhi Ty21a of claim 1, said DNA being under the control of the cognate promoters. 10. A composition of matter comprising the Salmonella typhi Ty21a of claim 1 in combination with a physiologically acceptable carrier. 11. A vaccine comprising the Salmonella typhi Ty21a of claim 1 in combination with a physiologically acceptable carrier. 12. A method of prophylactic or therapeutic treatment of bacterial infection comprising administering a prophylactically or therapeutically effective amount of the Salmonella typhi Ty21a of claim 1 to an individual for prescription of said treatment. 13. A method of making a vaccine comprising combining the Salmonella typhi Ty21a of claim 1 with a physiologically acceptable carrier. 14. Purified and isolated DNA encoding rfbB having SEQ ID NO: 3. 15. Purified and isolated DNA encoding rfbC having SEQ ID NO: 4. 16. Purified and isolated DNA encoding rfbA having SEQ ID NO: 5. 17. Purified and isolated DNA encoding rfbD having SEQ ID NO: 6 or a polypeptide that has at least about 99%, at least about 95%, at least about 90%, or at least about 85% identity thereto and retains rfbD biological activity. 18. Purified and isolated DNA encoding rfc having SEQ ID NO: 8. 19. Purified and isolated DNA encoding rfbQ having SEQ ID NO: 10. 20. Purified and isolated DNA encoding rfp having SEQ ID NO: 12. 21. An expression vector comprising a core-linked Shigella dysenteriae serotype 1 O-specific polysaccharide (O-Ps) and DNA encoding O antigen biosynthesis, said DNA selected from the group consisting of: a) the DNA sequence set out in any one of SEQ ID NOs: 1 and 2 and nucleic acid molecules from the species Shigella dysenteriae serotype 1 that share at least about 90% sequence identity with the nucleic acid molecule of SEQ ID NO:1 or 2; and b) DNA encoding Shigella dysenteriae serotype 1 polypeptides encoded by any one of SEQ ID NOs: 1 and 2 and nucleic acid molecules from the species Shigella dysenteriae serotype 1 that share at least about 90% sequence identity with the nucleic acid molecule of SEQ ID NO:1 or 2. 22. The expression vector of claim 21, wherein the vector is a plasmid construct. 23. The plasmid construct of claim 22, wherein the plasmid is pGB2. 24. The Salmonella typhi Ty21a of claim 1, wherein the DNA encoding O antigen biosynthesis is partially or wholly chemically synthesized. 25. The expression vector of claim 4, wherein the DNA encoding O antigen biosynthesis is partially or wholly chemically synthesized.

Details for Patent 8,071,113

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		2024-05-24