# US 6,537,559 B2 · Staphylococcus aureus antigen-containing whole cell vaccine

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- Number: US 6,537,559 B2
- Document ID: US6537559B2
- Status: Granted
- Kind: B2
- Application number: 09/961,110
- Filed: 2001-09-24
- Published: 2002-03-14
- Granted: 2003-03-25
- Earliest claimed: 1996-09-11
- Assignees: Nabi
- Inventors: Ali Ibrahim Fattom
- Web page: https://patentgrep.com/patent/US6537559B2

## CPC

- G01N 33/56938: {Staphylococcus}
- A61K 39/085: Staphylococcus
- A61P 5/00: Drugs for disorders of the endocrine system
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- C07K 16/1271: Micrococcaceae (F); Staphylococcaceae (F), e.g. Staphylococcus (G)
- A61K 2039/505: {comprising antibodies}
- A61K 2039/521: {inactivated (killed)}
- A61K 2039/6037: {Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

A negatively-charged S. aureus antigen contains β-hexosamine as a major carbohydrate component. S. aureus strains that carry the antigen account for nearly all of the clinically significant strains of S. aureus that are not Type 5 or Type 8 strains. The antigen can be used in combination with S. aureus Type 5 polysaccharide antigen and S. aureus Type 8 polysaccharide antigen to provide nearly 100% coverage of S. aureus infection. The antigen and antibodies to the antigen are useful in kits and assays for diagnosing S. aureus infection. A whole cell vaccine of cells that contain the antigen is particularly useful in the treatment of mastitis.

## Claims

### Claim 1

An immunotherapy method comprising administering to a subject an immunostimulatory amount of a composition that comprises (A) cells, cell lysates, or cell derivatives of Staphylococcus aureus which carry an antigen that (i) comprises β-linked hexosamine, (ii) contains no O-acetyl groups detectable by nuclear magnetic resonance spectroscopy, and (iii) specifically bind with antibodies to Staphylococcus aureus Type 336 deposited under ATCC 55804, and (B) a pharmaceutically acceptable carrier.

### Claim 2

An immunotherapy method comprising administering to a subject an immunostimulatory amount of a composition prepared by a process comprising
selecting cells of Staphylococcus aureus which carry an antigen that (i) comprises β-linked hexosamine, (ii) contains no O-acetyl groups detectable by nuclear magnetic resonance spectroscopy, and (iii) specifically binds with antibodies to Staphylococcus aureus Type 336 deposited under ATCC 55804,
inactivating said cells, and
mixing said cells, or lysates or derivatives of said cells, with a pharmaceutically acceptable carrier.

### Claim 3

A method of preparing a whole cell vaccine, comprising
selecting cells of Staphylococcus aureus which carry an antigen that (i) comprises β-linked hexosamine, (ii) contains no O-acetyl groups detectable by nuclear magnetic resonance spectroscopy, and (iii) specifically binds with antibodies to Staphylococcus aureus Type 336 deposited under ATCC 55804, or lysates or derivatives of said cells,
inactivating said cells, and
mixing said cells, or lysates or derivatives of said cells, with a pharmaceutically acceptable carrier,
wherein said cells are selected using antibodies to said antigen.

### Claim 4 (depends on 3)

A method of preparing an immunotherapeutic agent against S. aureus infection, comprising:
immunizing subjects with a composition according to claim 3,
collecting plasma from said immunized subjects, and
havesting antibodies directed against S. aureus from said collected plasma.