# US 2002/0031528 A1 · Staphylococcus aureus antigen-containing whole cell vaccine

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- Number: US 2002/0031528 A1
- Document ID: US20020031528A1
- Status: Published application
- Kind: A1
- Application number: 09/961,110
- Filed: 2001-09-24
- Published: 2002-03-14
- Earliest claimed: 1996-09-11
- Assignees: Nabi
- Inventors: Ali Ibrahim Fattom
- Web page: https://patentgrep.com/patent/US20020031528A1

## 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

A vaccine that comprises (A) cells, cell lysates, or cell derivatives of Staphylococcus aureus which carry an antigen that (a) comprises β-linked hexosamine, (b) contains no O-acetyl groups detectable by nuclear magnetic resonance spectroscopy, and (3) specifically bind with antibodies to Staphylococcus aureus Type 336 deposited under ATCC 55804, and a pharmaceutically acceptable carrier.

### Claim 2 (depends on 1)

A method of preparing a whole cell vaccine according to claim 1, comprising:
selecting cells of Staphylococcus aureus which carry an antigen that (a) comprises β-linked hexosamine, (b) contains no O-acetyl groups detectable by nuclear magnetic resonance spectroscopy, and (3) specifically bind 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 (depends on 2)

A method of preparing a whole cell vaccine according to claim 2, wherein said cells are selected using antibodies to said antigen.

### Claim 4 (depends on 3)

A method of preparing a whole cell vaccine according to claim 3, wherein said antibodies are monoclonal antibodies prepared using isolated antigen.

### Claim 5 (depends on 2)

A vaccine, prepared by the method of claim 2.

### Claim 6 (depends on 3)

A vaccine, prepared by the method of claim 3.

### Claim 7 (depends on 1)

An immunotherapy method comprising administering to a subject an immunostimulatory amount of a composition as claimed in claim 1.

### Claim 8 (depends on 7)

An immunotherapy method according to claim 7, wherein said subject is a female animal at risk for developing mastitis.

### Claim 9 (depends on 7)

An immunotherapy method according to claim 7, wherein said subject is a female animal with mastitis.

### Claim 10 (depends on 3)

An immunotherapy method comprising administering to a subject an immunostimulatory amount of a composition as claimed in claim 3.

### Claim 11 (depends on 10)

An immunotherapy method according to claim 10, wherein said subject is a female animal at risk for developing mastitis.

### Claim 12 (depends on 7)

An immunotherapy method according to claim 7, wherein said subject is a female animal with mastitis.

### Claim 13 (depends on 1)

A method of preparing an immunotherapeutic agent against S. aureus infection, comprising:
immunizing subjects with a composition according to claim 1;
collecting plasma from said immunized subjects; and
harvesting antibodies directed against S. aureus from said collected plasma.

### Claim 14 (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
harvesting antibodies directed against S. aureus from said collected plasma.

### Claim 15 (depends on 13)

An immunotherapeutic agent against S. aureus infection, comprising antibodies prepared by the method of claim 13 in a pharmaceutically-acceptable carrier.

### Claim 16 (depends on 14)

An immunotherapeutic agent against S. aureus infection, comprising antibodies prepared by the method of claim 14 in a pharmaceutically-acceptable carrier.

### Claim 17 (depends on 15)

An immunotherapy method comprising administering to a subject an immunotherapeutic agent as claimed in claim 15.

### Claim 18 (depends on 15)

An immunotherapy method according to claim 15, wherein said subject is a female animal that has mastitis.

### Claim 19 (depends on 16)

An immunotherapy method comprising administering to a subject an immunotherapeutic agent as claimed in claim 16.

### Claim 20 (depends on 16)

An immunotherapy method according to claim 16, wherein said subject is a female animal that has mastitis.

### Claim 21 (depends on 1)

A vaccine according to claim 1, additionally comprising cells, cell lysates, or cell derivatives of Staphylococcus aureus which carry Type 5 antigen, and cells, cell lysates, or cell derivatives of Staphylococcus aureus which carry Type 8 antigen.

### Claim 22 (depends on 21)

A method of preparing an immunotherapeutic agent against S. aureus infection, comprising:
immunizing subjects with a composition according to claim 21;
collecting plasma from said immunized subjects; and
harvesting antibodies directed against S. aureus from said collected plasma.
