Shigella protein antigens and methods

• US 8,147,847 B2
• Filed: 10/21/2009
• Issued: 04/03/2012
• Est. Priority Date: 10/21/2008
• Status: Active Grant

• Current Assignee: International Vaccine Institute
• Original Assignee: International Vaccine Institute
• Inventors: Czerkinsky, Cecil, Kim, Dong Wook
• Primary Examiner(s): Swartz, Rodney P.
• Application Number:
  US12/603,574
• Publication Number:
  US 20100124556A1
• Time in Patent Office: 895 Days
• Field of Search: 424/9.1, 424/9.2, 424/184.1, 424/185.1, 424/190.1, 424/193.1, 424/197.11, 424/234.1, 435/41, 435/71.1, 435/243, 530/300, 530/350
• US Class Current: 424/234.1
• CPC Class Codes: A61K 2039/55566 Emulsions, e.g. Freund's adjuvant, MF59
• CPC Class Codes: A61K 2039/6037 Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
• CPC Class Codes: A61K 2039/6087 Polysaccharides; Lipopolysaccharides [LPS]
• CPC Class Codes: A61K 39/0283 Shigella
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: C07K 14/25 Shigella (G)
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention relates to protein antigens IcsP2 and SigA2 from Shigella that are common among numerous Shigella types and species and which can protect against shigellosis or other enteric infections when administered as vaccines. In addition, the present invention relates to antigens that are in common between Shigella species and enteroinvasive Escherichia coli (EIEC). The invention also relates to the use of antibodies raised against these antigens and of DNA probes for use in the diagnosis of Shigella and EIEC infections.

Claims

1. A vaccine composition for immunizing a mammal against Shigella comprising an amount of Shigella IcsP2 protein or SigA2 protein effective to elicit an immune response against Shigella, and a pharmaceutically acceptable carrier or diluent.

9. The vaccine composition of claim 1, further comprising an adjuvant.

11. A method of treating a mammal suffering from or susceptible to a pathogenic infection caused by Shigella, comprising administering an effective amount of the vaccine composition of claim 1.

12. The method of claim 11, wherein the effective amount of the vaccine composition ranges between about 10 micrograms and about 2 milligrams.

13. A method for modulating the immune response of a mammal comprising administering an effective amount of the vaccine composition of claim 1.

14. The method of claim 13, wherein the effective amount of the vaccine composition ranges between about 10 micrograms and about 2 milligrams.

2. A vaccine composition for immunizing a mammal against Shigella comprising an amount of Shigella IcsP2 protein effective to elicit an immune response against Shigella, and a pharmaceutically acceptable carrier or diluent.

3. The vaccine composition of claim 2 wherein said IcsP2 protein is chemically conjugated to a carrier protein.

5. The vaccine composition of claim 2 wherein said IcsP2 protein is a fusion of an IcsP2 protein and a carrier protein.

8. The vaccine composition of claim 3, wherein the carrier protein is selected from the group consisting of tetanus toxoid, diphtheria toxoid, cholera toxin B subunit, E. coli enterotoxin B subunit and flagellin.

10. The vaccine composition of claim 5, further comprising an adjuvant wherein said adjuvant is an oil phase of an emulsion selected from a group consisting of a water-in-oil emulsion and a double oil emulsion.

15. The vaccine composition of claim 2, further comprising an adjuvant.

17. A method of treating a mammal suffering from or susceptible to a pathogenic infection caused by Shigella, comprising administering an effective amount of the vaccine composition of claim 2.

4. A vaccine composition for immunizing a mammal against Shigella comprising an amount of Shigella SigA2 protein effective to elicit an immune response against Shigella, and a pharmaceutically acceptable carrier or diluent.

6. The vaccine composition of claim 4 wherein said SigA2 protein is chemically conjugated to a carrier protein.

7. The vaccine composition of claim 4 wherein said SigA2 protein is a fusion of a carrier and an SigA2 protein.

16. The vaccine composition of claim 4, further comprising an adjuvant.

18. A method of treating a mammal suffering from or susceptible to a pathogenic infection caused by Shigella, comprising administering an effective amount of the vaccine composition of claim 4.