Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
1997-10-03
2001-09-11
Smith, Lynette R. F. (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S234100, C424S184100, C424S093100, C424S093400, C424S823000, C435S243000, C435S252100
Reexamination Certificate
active
06287575
ABSTRACT:
CROSS REFERENCE TO RELATED APPLICATIONS
Not applicable.
FIELD OF THE INVENTION
This invention relates to the diagnosis and prevention of ungulate diseases caused by treponeme spirochete bacteria. The invention specifically relates to isolated cultures of these spirochetes and their isolated nucleic acids and proteins.
BACKGROUND OF THE INVENTION
Over the past few years, there has been a marked increase in the prevalence of related painful diseases of the feet of dairy cattle called papillomatous digital dermatitis (PDD), digital dermatitis (DD) or interdigital dermatitis (IDD), hereinafter referred to as PDD. Commonly known as footwarts, PDD has been reported in the USA, Canada, Europe, the Mediterranean, Japan, South Africa, Australia, and South America. This disease adversely affects the dairy industry economically through increased treatment costs and by its negative effect on milk production and reproductive performance. It appears as a contagious disease, with some herds having a 90% prevalence of clinical disease.
PDD causes severe lameness, decrease in body condition, and decreased reproductive performance in cattle. First calf heifers are most often affected. Little or no digital swelling occurs. The lesions are limited to the feet, usually the hind feet. Typically, lesions occur at the back of foot near the interditigal ridge. Lesions may range from small, dime-sized, flat, red and circumscribed lesions (early lesions) to large, raised, golf-ball sized, with long brown/black papillary fronds (mature lesions). The long (true) hairs at edge of lesion are frequently hypertrophied. The lesions may persist for many months or may regress in dry weather.
Various attempts to demonstrate viruses, structural group antigens of papillomavirus, and bovine papillomavirus types 1-6 in PDD have been negative (Basset et al.,
Vet. Rec.
126:164-165 (1990); Read et al.,
Vet. Rec.
130:59-60 (1992); Read et al.,
Proc. Amer. Ass. Vet. Lab. Diag.
38:68 (1995); Rebhun, et al.,
J. Am. Vet. Med. Assoc.
177:437-440 (1980); Scavia et al.,
Proc. Int. Sym. Dis. Rum. Digit
8:174-176 (1994); Zemljic,
Proc. Int. Sym. Rum. Digit
8:164-167 (1994)). Histologic examination for Dermatophilus spp., fungi, and parasites also have been negative (Read et al.,
Proc. Amer. Ass. Vet. Lab. Diag.
38:68 (1995)).
Because the disease responds to topical or parenteral treatment with antibiotics, a bacterial role in the disease process has been indicated. Spirochetes have been demonstrated invading into the stratum spinosum and dermal papillae of PDD lesions and are the predominant bacterial morphotype present. Spirochetes with morphologic, phenotypic, and genetic characteristics of the genus Treponema have been isolated from PDD lesions (Walker et al.,
Vet. Micro.
47:343-355 (1995); Walker et al.,
AJVR
58:744-748 (1997)). Intralesional invasive spirochetes have also been demonstrated in PDD worldwide (Blowey et al.,
Vet. Rec.
135, 115-117 (1994); Scavia et al.,
Proc. Int. Sym. Dis. Rum. Digit
8:174-176 (1994); Zemljic,
Proc. Int. Sym. Rum. Digit
8:164-167 (1994); Kimura et al.,
J. Vet. Med. Jpn.
46:899-906 (1993); Dopfer et al.,
Vet. Rec.
140:620-623 (1997); Choi et al.,
Int. J. Syst. Bact.
47:175-181 (1997); Rijpkema et al.,
Vet. Rec.
140:257-259 (1997)).
It remains unclear whether these spirochete organisms have a primary role in lesion development or whether they act as secondary opportunists after the initial PDD lesion has developed. For example, other bacteria such as Serpens spp., a gram negative rod related to members of the genus Pseudomonas, have also been suggested as a PDD agent. In the field, PDD appears contagious but most previous attempts to transmit PDD experimentally have not been successful (Weaver,
Proc.
7
th Biann. Int. Sym. Dis. Rum. Digit,
Copenhagen (1992); Basset et al.,
Vet. Rec.
126:164-165 (1990); but see Read & Walker,
Vet. Pathology
33:607 (1996)).
Currently, the etiologic agent of PDD is unknown. In addition, it is unknown whether PDD can spread to other species, although similar histopathologic lesions have been observed in sheep, horses, and goats. There is therefore a need to definitively identify the etiologic agent for PDD and to develop a means of preventing this disease by developing a vaccine against PDD.
SUMMARY OF THE INVENTION
The present invention identifies ungulate Treponema spp. as the etiologic agents of ungulate papillomatous digital dermatitis (PDD). The invention therefore provides isolated cultures of Treponema spp., vaccines that effectively immunize susceptible ungulates against PDD, and methods of diagnosing PDD by detecting infection with Treponema spp.
In one aspect, the invention provides a biologically pure culture of ungulate Treponema.
In one embodiment, the culture has all the characteristics of Treponema strain 1-9185MED (ATCC Accession No. 202030) or Treponema strain 2-1498 (ATCC Accession No. 202031). In another embodiment, the culture is selected from the group consisting of Treponema strain 1-9185MED (ATCC Accession No. 202030) and Treponema strain 2-1498 (ATCC Accession No. 202031).
In another aspect, the invention provides a pharmaceutical composition comprising a pharmaceutically acceptable carrier and an immunogenically effective amount of an ungulate Treponema antigen.
In another aspect, the invention provides a method for inducing an immune response against ungulate Treponema. This method includes the step of administering to an ungulate animal a pharmaceutical composition comprising a pharmaceutically acceptable carrier and an immunogenically effective amount of an ungulate Treponema antigen.
In one embodiment, the composition further includes an antigen from an organism that causes ungulate foot rot selected from the group consisting of
Fusobacterium necrophorum, Porphyromonas levii,
and
Dichelobacter nodosus.
In another embodiment, the pharmaceutical composition further comprises a bovine respiratory syncytial virus antigen, a bovine Herpes virus antigen, a leptospiral antigen, a bovine diarhhea virus antigen, a bovine parainfluenza virus antigen, a vesicular stomatitis virus antigen, a malignant catarrhal fever virus antigen, a blue tongue virus antigen, a pseudorabies virus antigen, a rabies virus antigen, a rinderpest virus antigen, a
Fusobacterium necrophorum
antigen, a
Dichelobacter nodosus
antigen, or a Clostridia spp. antigen.
In another embodiment, the ungulate Treponema antigen is from Treponema strain 1-9185MED (ATCC Accession No. 202030) or Treponema strain 2-1498 (ATCC Accession No. 202031). In another embodiment, the antigen is a biologically pure culture of Treponema. In another embodiment, the antigen is selected from the group consisting of Treponema strain 1-9185MED (ATCC Accession No. 202030) and Treponema strain 2-1498 (ATCC Accession No. 202031). In another embodiment, the ungulate Treponema antigen is an isolated Treponema polypeptide. In another embodiment, the polypeptide is recombinantly produced.
In another embodiment, the pharmaceutical composition is administered parenterally.
In another aspect, the invention provides a method of detecting the presence of antibodies specifically immunoreactive with an ungulate Treponema antigen in a biological sample. This method includes the steps of contacting the sample with the Treponema antigen, thereby forming a antigen/antibody complex; and detecting the presence or absence of the complex.
In one embodiment, the Treponema antigen is from Treponema strain 1-9185MED (ATCC Accession No. 202030) or Treponema strain 2-1498 (ATCC Accession No. 202031). In another embodiment, the biological sample is bovine serum. In another embodiment, the antigen is an isolated Treponema polypeptide. In another embodiment, the antigen is immobilized on a solid surface. In another embodiment, the complex is detected using a labeled anti-bovine antibody.
In another aspect, the invention provides a method of detecting the presence of ungulate Treponema in a biological sample. This method includes the steps of contacting the sample with an antibody specific
Berry Steven L.
Cullor James S.
Hird David W.
Lefebvre Rance B.
Lefler Hank M.
Portner Ginny Allen
Smith Lynette R. F.
The Regents of the University of California
Townsend and Townsend / and Crew LLP
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