Prevention of infection

Patent metadata

Field	Value
Publication number	US-9932392-B2
Application number	US-201314383962-A
Country	US
Kind code	B2
Filing date	Mar 8, 2013
Priority date	Mar 9, 2012
Publication date	Apr 3, 2018
Grant date	Apr 3, 2018

Abstract

The invention relates to compositions and methods to prevent enteric infection in a subject at risk of such infection. In particular, the invention relates to the prevention of recurrence of infection by Clostridium difficile.

First claim

The invention claimed is:

1. A method of preventing or preventing recurrence of an infection by an enteric pathogen in a subject at risk of infection, which comprises:
administering to the subject an effective amount of a composition comprising a secretory component and an immunoglobulin, said immunoglobulin derived from pooled human plasma,
wherein the enteric pathogen is C. difficile, S. enteritidis, S. flexneri , and/or E. faecium , and wherein the immunoglobulin comprises J chain-containing IgA.

2. The method of claim 1 , wherein the subject at risk of infection has received antibiotic treatment for a primary Clostridium difficile infection.

3. The method of claim 1 , wherein the secretory component is a recombinant secretory component.

4. The method of claim 3 , wherein the recombinant secretory component is produced in a mammalian cell line.

5. The method of claim 1 , wherein the secretory component is isolated from a natural source.

6. The method of claim 1 , wherein the secretory component is human.

7. The method of claim 1 , wherein the secretory component is the extracellular portion of a polymeric immunoglobulin receptor pIgR.

8. The method of claim 1 , wherein the J chain-containing IgA comprises dimeric IgA.

9. The method of claim 1 , wherein the IgA comprises anti- Clostridium and/or antitoxin IgA.

10. The method of claim 1 , wherein the immunoglobulin further comprises IgM.

11. The method of claim 1 , wherein administration is accomplished by oral or anal administration.

12. The method of claim 1 , wherein administration of the composition is initiated after successful treatment of a Clostridium difficile infection by one or more antibiotics.

13. The method of claim 12 , wherein administration of the composition is initiated up to 48 hours prior to conclusion of antibiotic treatment, or when antibiotic treatment is concluded, or shortly after conclusion of antibiotic treatment.

14. The method of claim 1 , wherein administration of the composition prevents or prevents recurrence of sequelae of the enteric infection.

15. The method of claim 1 , wherein the enteric pathogen is S. enteritidis.

16. The method of claim 1 , wherein the enteric pathogen is S. flexneri.

17. The method of claim 1 , wherein the enteric pathogen is E. faecium.

18. A method of preventing or preventing recurrence of an infection by an enteric pathogen in a subject at risk of infection, which comprises:
administering to the subject an effective amount of a composition comprising a secretory component and an immunoglobulin, said immunoglobulin derived from pooled human plasma, wherein the enteric pathogen is Clostridium difficile , and wherein the immunoglobulin comprises J chain containing IgA.

19. The method of claim 1 , wherein at least 30% of the immunoglobulin of the composition is J-chain containing IgA.

20. The method of claim 1 , wherein the composition prevents recurrence of C. difficile for at least 1 month after administration.

21. The method of claim 13 , wherein the antibiotic is vancomycin.

Assignees

• Csl Behring Ag
• Beth Israel Deaconess Medical Ct Inc

Inventors

• Kelly Ciaran
• Chen Xinhua
• Miescher Sylvia
• Spycher Martin
• Wymann Sandra
• Zuercher Adrian

Classifications

• A61K39/395

  Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum · CPC title

• A61K38/1774

  Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules) · CPC title

• C07K16/1282 Primary

  Clostridium (G) · CPC title

• A61K38/14

  Peptides containing saccharide radicals; Derivatives thereof {, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin} · CPC title

• A61K2039/505

  comprising antibodies · CPC title