Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Parasitic organism or component thereof or substance...
Reexamination Certificate
2001-11-09
2004-09-07
Graser, Jennifer E. (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Parasitic organism or component thereof or substance...
C424S265100, C424S184100, C424S193100
Reexamination Certificate
active
06787146
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a vaccine against the pathogenic protozoan Neospora which vaccine is useful in the prevention of clinical disease and abortion in mammals. The vaccine of the invention comprises an homogenate prepared from cells of a species of Neospora.
BACKGROUND OF THE INVENTION
Neosporosis in mammals is caused by infection with a pathogenic strain of the protozoan parasite Neospora, and has been recognized as a major cause of abortion, neonatal death, congenital infection, and encephalitic disease. Dubey and Lindsay, 1996, Vet. Parasitol. 67:1-59; Dubey and Lindsay, 1993, Parasitol. Today 9:452-458
. Neospora caninum
infects dogs and congenitally infects pups, often leading to paralysis. Tachyzoites of
N. caninum
have been isolated from naturally infected pups. Lindsay and Dubey, 1989, J. Parasitol. 75:163-165. Infection with Neospora is also a major cause of abortion in dairy cattle. Cases of neosporosis have also been reported in goats, sheep and horses.
Although
N. caninum
is superficially similar to the pathogen
Toxoplasma gondii, N. caninum
and
T. gondii
are distinguishable from each other both antigenically and ultrastructurally. Dubey and Lindsay, 1993, above. In addition, Neospora-like protozoan parasites isolated from the brains of aborted bovine fetuses and continuously cultured in vitro were shown to be antigenically and ultrastructurally distinct from both
T. gondii
and
Hammondia hammondi
, and most similar to
N. caninum
. Conrad et al., 1993, Parasitology 106:239-249. Furthermore, analysis of nuclear small subunit ribosomal RNA genes revealed no nucleotide differences between Neospora strains isolated from cattle and dogs, but showed consistent differences when compared to
T. gondii
, thus confirming the distinction between pathogens. Marsh et al., 1995, J. Parasitol. 81:530-535.
The etiologic role of a bovine isolate of Neospora in bovine abortion and congenital disease has been confirmed. Barr et al. 1994, J. Vet. Diag. Invest. 6:207-215. A rodent model of central nervous system neosporosis has been developed using inbred BALB/c mice infected with
N. caninum
. Lindsay et al, 1995, J. Parasitol. 81:313-315. In addition, models to study transplacental transmission of
N. caninum
in pregnant outbred and inbred mice have been described by Cole et al., 1995, J. Parasitol. 81:730-732, and by Long et al., 1996, J. Parasitol. 82:608-611, respectively. Furthermore, an experimental
N. caninum
pygmy goat model closely resembling naturally acquired Neospora-induced cattle abortion has been developed. Lindsay etal., 1995, Am. J. Vet. Res. 56:1176-1180.
WO 9525541 discloses a biologically pure culture of bovine Neospora, methods of detecting anti-Neospora antibodies and Neospora-specific nucleic acids, and a composition containing a bovine Neospora antigen and carrier for use as a vaccine.
An effective vaccine against neosporosis comprising an homogenate prepared from cells of Neospora has not previously been disclosed.
SUMMARY OF THE INVENTION
In a first aspect, the present invention provides an homogenate prepared from cells of Neospora, which homogenate is capable of inducing a protective response against neosporosis in a mammal.
In a second aspect, the present invention provides a vaccine to protect a mammal against neosporosis, comprising an immunologically effective amount of an homogenate prepared from cells of Neospora, which homogenate is capable of inducing a protective response against neosporosis in a mammal, and a veterinarily acceptable carrier. The vaccine of the present invention may further comprise one or more additional immunomodulatory components including, e.g., an adjuvant or cytokine.
In a third aspect, the present invention provides a method for preparing a vaccine that protects a mammal against neosporosis, comprising homogenizing cells of Neospora to form an homogenate capable of inducing a protective response against neosporosis in a mammal. and combining an immunologically effective amount of the homogenate with a veterinarily acceptable carrier in a form suitable for administration to the mammal.
In a fourth aspect, the present invention provides a method for protecting a mammal against neosporosis, comprising administering to the mammal a vaccine comprising an immunologically effective amount of an homogenate prepared from cells of Neospora, which homogenate is capable of inducing a protective response against neosporosis in a mammal, and a veterinarily acceptable carrier. The vaccine of the present invention may be administered to any mammalian species susceptible to infection and disease caused by Neospora, including but not limited to dogs, cows, goats, sheep and horses.
In a fifth aspect, the present invention provides a combination vaccine for protecting a mammal against neosporosis and, optionally, one or more other diseases or pathological conditions that can afflict the mammal, which combination vaccine comprises an immunologically effective amount of a first composition comprising an homogenate prepared from cells of Neospora, which homogenate is capable of inducing a protective response against neosporosis in a mammal; an immunologically effective amount of a second composition capable of inducing a protective response against a disease or pathological condition that can afflict the mammal; and a veterinarily acceptable carrier.
The second composition of the combination vaccine is selected based on its ability to induce a protective response against either neosporosis or another disease or pathological condition that can afflict members of the mammalian species, as known in the art. The combination vaccine of the present invention may further comprise one or more additional immunomodulatory components including, e.g., an adjuvant or cytokine, among others.
In a sixth aspect, the present invention provides a kit for vaccinating a mammal against neosporosis, comprising a first container having an immunologically effective amount of an homogenate prepared from cells of Neospora, which homogenate is capable of inducing a protective response against neosporosis in a mammal, and a second container having a veterinarily acceptable carrier or diluent suitable for mixing with the contents of the first container.
In a seventh aspect, the present invention provides antibodies specific to one or more antigenic components present in an homogenate prepared from cells of Neospora.
REFERENCES:
patent: 5707617 (1998-01-01), Conrad et al.
patent: 5889166 (1999-03-01), Conrad et al.
patent: 0734731 (1996-10-01), None
patent: 0764446 (1997-03-01), None
patent: 9525541 (1995-09-01), None
patent: 95/25541 (1995-09-01), None
patent: 9717082 (1997-05-01), None
Barr et al. J. Vet. Diagnosis. 1993. 6(2): 7308.*
Lindsay et al. Am. J. Vet. Res., 1995. 56(9): 1176-1180.*
Lindsay et al. J. Parasitol. 1990. 76(3): 410-413.*
Barta et al. Parasitol. Res. 1992. 78: 689-694.*
Barr et al., 1994, J. Vet. Diagn. Invest. 6:207-215, “Experimental reproduction of bovine fetal Neospora infection and death with a bovineNeospora isolate.”
Cole et al., 1995, J. Parasitol. 81:730-732, “Vertical transmission ofNeospora caninumin mice.”
Conrad et al., 1993, Parasitol. 106:239-249, “In vitro isolation and characterization of a Neospora sp. from aborted bovine foetuses.”
Dubey and Lindsay, 1993, Parasitol. Today 9:452-458, “Neosporosis.”
Lindsay et al., 1995, J. Parasitol. 81:313-315, “Mouse model for central nervous systemNeospora caninuminfections.”
Lindsay et al., 1995, Am. J. Vet. Res. 56:1176-1180, “Abortions, fetal deaths and stillbirths in pregnant pygmy goats inoclated with tachyzoites ofNeospora caninum.”
Lindsay and Dubey, 1989, J. Parasitol. 75:772-779, “Neospora caninum(Protozoa: Apicomplexa) infections in mice.”
Lindsay and Dubey, 1989, J. Parasitol. 75:163-165, “In vitro development ofNeospora caninum(Protozoa: Apicomplexa) from dogs.”
Lindsay and Dubey, 1990, J. Parasitol. 76:410-413, “Infections in mice with tachyzoites and bradyzoites ofNeospora caninum(protozoa: Apicomplexa).”
Barta et al., 1992, Parasito
Brake David A.
Campos Manuel
Graser Jennifer E.
Pfizer Inc.
Scully Scott Murphy & Presser
LandOfFree
Neospora vaccine does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Neospora vaccine, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Neospora vaccine will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3273570