Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
1998-06-22
2001-02-27
Minnifield, Nita (Department: 1645)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S007200, C435S007230, C435S007500, C435S007900, C435S029000, C435S035000, C435S975000, C435S810000, C435S822000, C435S964000
Reexamination Certificate
active
06194161
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 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.
A
S. aureus
vaccine would provide a solution for the problem of antibiotic resistance. 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 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
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 an antigen common to
S. aureus
strains of clinical significance that are not Type 5 or Type 8 strains.
It is a further object to provide a vaccine that contains an antigen common to
S. aureus
strains that are not Type 5 or Type 8 strains.
It is yet another object to provide a vaccine that contains
S. aureus
Type 5 antigen,
S. aureus
Type 8 antigen and an antigen common to
S. aureus
strains that are not Type 5 or Type 8 strains.
It is another object to provide a hyperimmune globulin composition that contains antibodies directed against Type 5 antigen, Type 8 antigen and an antigen common to
S. aureus
strains that are not Type 5 or Type 8 strains.
It is a further object to provide a kit and assay for diagnosing
S. aureus
infection.
In accordance with these and other objects according to the invention, there is provided an isolated
Staphylococcus aureus
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
S. aureus
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, at least one of a
S. aureus
Type 5 polysaccharide antigen and a
S. aureus
Type 8 polysaccharide antigen, and a sterile, pharmaceutically-acceptable carrier therefor. An immunotherapy method comprises a step of administering to a subject an immunostimulatory amount of such a composition.
A method of preparing an immunotherapeutic agent against
S. aureus
infection comprises steps of immunizing subjects with a composition according to the invention, collecting plasma from the immunized subjects, and harvesting a 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, and additionally may contain antibodies directed against
S. aureus
Type 5 polysaccharide antigen and
S. aureus
Type 8 polysaccharide antigen. An immunotherapy method comprises a step of administering this hyperimmune globulin to a subject.
A monoclonal antibody to an
S. aureus
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 is provided, as well as a diagnostic assay for detecting the presence of anti-
S. aureus
antigen in a sample, comprising the steps of mixing such a monoclonal antibody with a sample suspected of containing
S. aureus
antigen and monitoring the mixture for binding between the antigen and the monoclonal
S. aureus
antibody. In a preferred embodiment, the monoclonal antibody is immobilized on a solid matrix. A kit for carrying out the assay comprises monoclonal antibody to a
S. aureus
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, and instructions for mixing the monoclonal antibody with a sample suspected of containing
S. aureus
-specific antigen and monitoring the mixture for binding between with
S. aureus
-specific antigen in the sample. The kit additionally may comprise at least one of Type 5 and Type 8
S. aureus
monoclonal antibody which are mixed with the sample, and preferably comprises both Type 5 and Type 8 monoclonal antibodies.
Another diagnostic assay for detecting the presence of anti-
S. aureus
antibody in a sample is provided which comprises the steps of mixing a
S. aureus
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, with a sample suspected of containing
S. aureus
-specific antibody and monitoring the mixture for binding between the antigen and
S. aureus
-specific antibody in the sample. In a preferred embodiment, the antigen is immobilized on a solid matrix. A kit for carrying out the assay comprises a
S. aureus
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, and instructions for mixing the antigen with a sample suspected of containing
S. aureus
-specific antibody and monitoring the mixture for binding between with
S. aureus
-specific antibody in the sample. The kit additionally may comprise at least one of Type 5 and Type 8
S. aureus
antigen which are mixed with said sample, and preferably comprises both Type 5 and Type 8 antigens.
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: 4399229 (1983-08-01), Kelton et al.
patent: 4748020 (1988-05-01), Von Malsen-Ponickau
patent: 5032522 (1991-07-01), Watson
patent: 5472846 (1995-12-01), Rotman
patent: 5770208 (1998-06-01), Fattom et al.
patent: 5792617 (1998-08-01), Rotman
Anthony et al., “Gram Positive Bacteria: An Overview and Summary of Session” Reviews of infectious Diseases, 10:2 S345-S350 (1988).
Foster, “Potential for vaccination against infections caused byStaphyloccocus aureus” Vaccine 9:221-227.
Fattom, “Synthesis and Immunologic Properties in Mice of Vaccines Composed ofStaphylococcus aureusType 5 and Type 8 Capsular Polysaccharides Conjugated toPseudomonas aeruginosaExotoxin A” Infection and Immunity 58:2367-2374 (1990).
Fattom, “AStaphylococcus aureusCapsular Polysaccharide (CP) Vaccine and CP-Specific Antibodies Protect Mice against Bacterial Challenge” Infection and Immunity 64:5 1659-1665 (1996).
Fournier, “Purification and Characterization ofStaphylococcus aureusType 8 Capsular Polysa
Fattom Ali Ibrahim
Patel Atulkumar Induprasad
Foley & Lardner
Minnifield Nita
Nabi
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