Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
2001-09-24
2003-03-25
Housel, James (Department: 1648)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S137100, C424S165100
Reexamination Certificate
active
06537559
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a novel
Staphylococcus aureus
antigen, and to a method for obtaining and using the antigen.
S. aureus
causes several diseases in animals and in humans by various pathogenic mechanisms. The most frequent and serious of these diseases are bacteremia and its complications in hospitalized patients. In particular,
S. aureus
can cause wound infections and infections associated with catheters and prosthetic devices. Serious infections associated with
S. aureus
bacteremia include osteomyelitis, invasive endocarditis and septicemia. The problem is compounded by multiple antibiotic resistance in hospital strains, which severely limits the choice of therapy. In addition,
S. aureus
is a major cause of mastitis in dairy and beef cattle, where the infection causes a major loss of income.
A
S. aureus
vaccine would provide a solution for the problem of antibiotic resistance. At least eight different serotypes of
S. aureus
have been identified using polyclonal and monoclonal antibodies to capsular polysaccharide (CPS). Karakawa et al.,
J. Clin. Microbiol.
22:445 (1985). The contents of this document and all others listed herein are incorporated herein by reference.
Surveys have shown that approximately 85-90% of human clinical isolates, and a comparable, although somewhat lower percentage of animal clinical isolates, are capsular polysaccharide Type 5 or Type 8. An individual vaccinated with a vaccine containing Type 5 and Type 8 CPS antigens would be protected from infection by 85-90% of clinically-significant
S. aureus
strains, but a significant risk of infection still would exist. A vaccine containing antigens from the other six serotypes theoretically could provide 100% protection, but would require production and purification of six additional components. This would be untenable from a practical standpoint. On the other hand, an antigen common to the isolates not typeable as Type 5 or Type 8 would enable production of a vaccine containing only three antigens.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a whole cell vaccine of cells that carry an antigen that is common to a large number of clinically-significant
S. aureus
strains, particularly one that is common to strains associated with infections in animals, particularly cattle.
It is a further object of the invention to provide a whole cell vaccine for prevention or treatment of infections in animals, particularly mastitis in cattle.
It is another object of the invention to provide a hyperimmune globulin composition that contains antibodies directed against bacteria that carry an antigen that is common to a large number of clinically-significant
S. aureus
strains, particularly one that is common to strains associated with infections in animals, particularly cattle.
It is yet another object of the invention to provide a hyperimmune globulin composition that is effective in treatment of infections in animals, particularly mastitis.
In accordance with these and other objects according to the invention, there is provided a whole cell vaccine comprising cells from a strain of
Staphylococcus aureus
that carries an antigen that comprises &bgr;-linked hexosamine, that contains no O-acetyl groups detectable by nuclear magnetic resonance spectroscopy and that reacts with antibodies to ATCC 55804. Also provided is a composition comprising the whole cell vaccine, and a sterile, pharmaceutically-acceptable carrier therefor. The vaccine can be administered to a human or animal subject to provide protection against
S. aureus
infection. It is particularly useful in preventing mastitis in animals.
An immunotherapeutic agent against
S. aureus
infection, particularly against mastitis in animals, can be prepared by immunizing human or animal subjects with a composition according to the invention, collecting plasma from the immunized subjects, and harvesting a human or veterinary hyperimmune globulin that contains antibodies directed against
S. aureus
from the collected plasma. The hyperimmune globulin contains antibodies directed against the &bgr;-linked hexosamine antigen. An immunotherapy method comprises a step of administering this hyperimmune globulin to a human or animal subject, especially an animal with mastitis, to prevent or treat infection.
Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.
REFERENCES:
patent: 5571511 (1996-11-01), Fischer et al.
patent: 5770208 (1998-06-01), Fattom et al.
patent: 6194161 (2001-02-01), Fattom et al.
patent: WO 98/10788 (1998-03-01), None
patent: WO 00/56357 (2000-09-01), None
Foster; “Potential for Vaccination Against Infections Caused byStaphylococcus aureus”; Vaccine; vol. 9; pp. 221-227.
Fattom; “Synthesis and Immunologic Properties in Mice of Vaccines Composed ofStaphylococcus aureusType 5 and Type 8 Capsular Polysaccharides Conjugated of Pseudomonas Aeruginosa Extoxin A”; Infection and Immunity; vol. 58, No. 7; 1990; pp. 2367-2374.
Fournier; Purification and Characterization ofStaphylococcus auerusType 8 Capsular Polysaccharide; Infection and Immunity; vol. 45, No. 1; 1984; pp. 87-93.
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Fattom et al.; “aStaphylococcus aureusCapsular Polysaccharide (CP) Vaccine and CP—Specific Antibodies Protect Mice Against Bacterial Challenge”; Infection and Immunity; vol. 64, No. 5; May 1996; pp. 1659-1665.
Fattom et al., Laboratory and IClinical Evaluation of Conjugate Vaccines Composed ofStaphylococcus aureusType 5 and Type 8 Capsular Polysaccharides Bound to Pseudomonas Aeruginoas Recombinant Exoprotein A'; Infection and Immunity; vol. 61; Mar. 1993.
Waldman; “Monoclonal Antibodies in Diagnosis and Therapy;” Science; vol. 252, Jun. 21, 1991; pp. 1657-1662.
Roitt et al.; “Immunotherapy” Immunology; 4thEdition; 1996; pp. 20.0-20.10.
Anthony et al.; Gram Positive Bacteria: An Overview and Summary of Session Reviews of Infectious Diseases; vol. 10, No. 2; 1988; pp. 5345-5350.
Foley Shanon
Housel James
NABI
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