Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
2000-09-01
2003-04-08
Navarro, Mark (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S184100, C424S203100, C424S237100, C424S278100
Reexamination Certificate
active
06544529
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to bovine mastitis infections caused by
Staphylococcus aureus
and, more particularly, to vaccines derived from selected strains of
Staphylococcus aureus.
BACKGROUND
Bovine mastitis is the most important infectious disease affecting both the quality and quantity of milk production.
Staphylococcus aureus
(i.e.,
“S. aureus”
) is the prime agent causing bovine mastitis, and it is difficult to eliminate. In different countries, the prevalence of
S. aureus
mastitis ranges from 10% to 40% of all cows. The infected animals may serve as reservoirs of infection endangering other dairy cattle in the herd (Fox, L. K. and Hancock, D. 1989, “Effects of segregation on prevention of intramammary infection by
Staphylococcus aureus”,
J. Dairy Sci. 72:540-544).
Recent estimates suggest that the annual production losses due to
S. aureus
are over 15 million dollars in Israel and over 2 billion dollars in the USA. The prevalence of
S. aureus
mastitis in dairy cattle raises several concerns. This bacterium can cause severe damage to milk-synthesizing tissues, drastically reducing milk production and altering milk composition. For more information on bovine mastitis and its effects, see, for example: (1) Oliver, S. P., Sordillo, L. M, 1988, “Udder health in the periparturient period”, J Dairy Sd. 71:2584-2606; (2) Postle, D. S., Roguinsky, M., Poutrel, B., 1978, “Induced Staphylococcal infections in the bovine mammary gland”, Am J Vet Res. 39:29-35; (3) Sordillo, L. M., Nickerson, S. C and Akers, R. M., 1989, “Pathology of mastitis during lactogenesis: Relationships with bovine mammary structure and function”, J. Dairy Sci. 72: 228-240; (4) Watson, D. L., McColl, M. L., Davies, H. I., 1996, “Field trial of a Staphylococcal mastitis vaccine in dairy herds: clinical, subclinical and microbiological assessments”, Aust. Vet. J. 74:447-450.
Depending on the duration and the severity of the infection, the productive performance of dairy cattle may be diminished permanently. Therefore, the development of effective methods of controlling
S. aureus
mastitis will increase profitability to dairy producers by reducing costs. So far, post-milking teat disinfection and antibiotic therapy are the only widely accepted methods of mastitis control (National Mastitis Council, 1987, “Current concepts of bovine mastitis”, Arlington, Va.).
These methods are not cost-effective due to milk loss during and after antibiotic therapy. Moreover, antibiotic therapies formulated for intramammary use are generally unsuccessful in eliminating existing
S. aureus
infections or preventing the establishment of chronic diseases (Ziv, G., 1995, “Treatment of Mastitis: An overview of progress during the last ten years”, Proc. The 3rd Internal Mastitis Seminar, Tel Aviv, Israel 2-12).
There is also a growing concern over the presence of drug residues in the food supply as a consequence of these procedures. To date, culling chronically infected cows is often the only practical means of eliminating
S. aureus
from a herd.
Vaccination is a logical approach for controlling infectious diseases in food producing animals. However, the paucity of information regarding relevant antigens remains a major deterrent to successful immunization against
S. aureus
mastitis. To our knowledge, the known, commercially available
S. aureus
vaccines have shown limited efficacy under field conditions. See, for example:
In the USA:
1) Nickerson, S. C., Owens, W. E., Bodie, R. L, 1993, “Effect of a
Staphylococcus aureus
bacterin on serum antibody, new infection, and mammary histology in non lactating dairy cows”, J. Dairy Sci., 76:1290-1297;
2) Sears, P. M., Norcross. N. L., Kenny, K., Smith, B., Gonzalez, R. N., Romano, M. N., 1990, “Resistance to
Staphylococcus aureus
infections in staphylococcal vaccinated heifers”, Proc. Internatl. Symp. Bovine Mastitis, Indianapolis, Ind., p. 69.
3) Sordillo, L. M., Nickerson, S. C and Akers, R. M., 1989, “Pathology of mastitis during lactogenesis: Relationships with bovine mammary structure and function”, J. Dairy Sci., 72: 228-240; and
4) Yoshida K., Ichiman, Y., Narikawa, S., Evans, G. B., 1984, “Staphylococcal capsular for preventing mastitis in two herds in Georgia”, J. Dairy Sci., 67:620-627.
In Australia:
1) Watson, D. L., 1984, “Evaluation of attenuated, live staphylococcal mastitis vaccine in lactating heifers”, J. Dairy Sci., 67:2608-2613;
2) Watson, D. L., Schwartzkoff, C. L., 1990, “A field trial to test the efficacy of a staphylococcal mastitis vaccine in commercial dairies in Australia”, International Symposium on Bovine Mastitis, National Mastitis Council, Arlington, 73-76;
3) Watson, D. L., 1992, “Vaccination against experimental staphylococcal mastitis in dairy heifers”, Res. Vet. Sci., 53:346-353; and
4) Watson, D. L., McColl, M. L., Davies, H. I., 1996, “Field trial of a Staphylococcal mastitis vaccine in dairy herds: clinical, subclinical and microbiological assessments”, Aust. Vet. J., 74:447-450.
In Norway:
1) Nordhaug, M. L., Nesse, L. L., Norcross, N. L., Gudding, R., 1994, “A field trial with an experimental vaccine against
Staphylococcus aureus
mastitis in cattle. I. Clinical parameters”, J Dairy Sci., 77:1267-1275;
2) Pankey, J. W., et al., 1985, “Evaluation of protein A and a commercial bacterin as vaccines against
Staphylococcus aureus
mastitis by experimental challenge”, J. Dairy Sci., 68:726-731; and
3) Yoshida K., Ichiman, Y., Narikawa, S., Evans, G. B., 1984, “Staphylococcal capsular for preventing mastitis in two herds in Georgia”, J. Dairy Sci., 67:620-627.
For the most part, these conventional vaccines have not prevented the disease and show only a marginal benefit in ameliorating the severity and duration of clinical symptoms of
S. aureus
mastitis. Traditional
S. aureus
mastitis vaccines have included killed or attenuated bacteria, toxoids, and cell wall extracts from selected laboratory or field strains. See: (1) Nickerson, S. C.; (2) Sears, P. M.; (3) Watson, D. L. 1984; and (4) Watson, D. L., 1992; as cited above.
These previous attempts have not considered the significant variation among the different strains of
S. aureus
which cause mastitis.
Attempts to solve this problem are described in U.S. Pat. No. 4,840,794. However this solution has not been satisfactory.
It is, therefore, desirable to develop a vaccine which would overcome the above disadvantages and would prevent the occurrence of bovine mastitis infection or at least control such infections to a large extent.
REFERENCES:
patent: 4425330 (1984-01-01), Norcross et al.
Sompolinsky et al, Journal of Clinical Microbiology, Nov. 1985, p. 828-834.*
Poutrel et al, Journal of Clinical Microbology, Jan. 1988.*
Nickerson et al, Journal of Dairy Science, 76: 1290-1297.*
Guidry et al, Veterinary Microbiology, 59:(1997) 53-58.
Leitner Gabriel
Liubashewsky Eugenia
Trainin Ze'ev
Ford Vanessa L
Maabarot Products Ltd.
Navarro Mark
Snell&Wilmer LLP
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