Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Parasitic organism or component thereof or substance...
Reexamination Certificate
1999-05-28
2001-04-24
Stucker, Jeffrey (Department: 1648)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Parasitic organism or component thereof or substance...
C424S265100, C424S278100, C435S007220, C435S258100, C530S822000
Reexamination Certificate
active
06221366
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to vaccines against intestinal protozoa. In particular, vaccines against Giardia are disclosed.
REFERENCES
The following references are cited in this application as superscript numbers at the relevant portions of the application.
1. Taylor, et al., Human immune response to
Giardia lamblia
infection, J. Infect. Dis., 155: 137-140 (1987).
2. Gillon, Changes in the small intestinal mucosa in giardiasis, “Giardia and Giardiasis”, Erlandsen, et al., Eds., Plenum Press, New York, 163-183 (1984).
3. Wolfe, Clinical symptoms and diagnosis by traditional methods, “Human Parasitic Diseases, Volume 3—Giardiasis”, Meyer Ed., Elsevier Science Publishers, New York, 175-186 (1990).
4. Feely, et al., The biology of Giardia, “Human Parasitic Diseases, Volume 3—Giardiasis”, Meyer Ed., Elsevier Science Publishers, New York, 11-49 (1990).
5
. Steketee, et al., Recurrent outbreaks of giardiasis in a child day care center, Wis. Am. J. Pub. Health 79: 485-490 (1989).
6. Faubert, Evidence that giardiasis is a zoonosis, Parasitology Today, 4 (3): 66-71 (1988).
7. Roach, et al., Transmission of
Giardia duodenalis
from human and animal sources in wild mice, “Advances in Giardia Research”, Wallis, et al., Eds., Univ. Calgary Press, Calgary, 79-82 (1988).
8. Swabby, et al., Infection of mongolian gerbils (
Meriones unguiculatus
) with Giardia from human and animal sources, “Advances in Giardia Research”, Wallis, et al., Eds., Univ. Calgary Press, Calgary, 75-77 (1988).
9. Jakubowski, Purple burps and the filtration of drinking water supplies, Am. J. Pub. Health, 78: 123-125 (1988).
10. Buret, et al., Zoonotic potential of giardiasis in domestic ruminants, J. Infect.
Dis., 155: 137-140 (1987).
11. Vinayak, et al., Systemic oral immunization with 56 kDa molecule of
Giardia lamblia
affords protection in experimental mice, Vaccine 10: 21-27 (1992).
12. Buret, et al., Effects of murine giardiasis on growth, intestinal morphology and disaccharidase activity, J. Parasitol. 76 (3): 403-409 (1990).
13. Buret, et al., Growth, activities of enzymes in the small intestine, and ultrasonic of microvillus border in gerbils infected with
Giardia duodenalis,
Parasitol. Res. 77: 109-114 (1991).
14. Janoff, et al., The role of immunity in Giardia infections, “Human Parasitic Diseases, Volume 3—Giardiasis”, Meyer Ed., Elsevier Science Publishers, New York, 215-235 (1990).
15. Lewis, et al., Cortisone-induced recrudescence of
Giardia lamblia
infections in gerbils, Am. J. Trop. Med. Hyg. 36 (1): 33-40 (1987).
16. Istre, et al., Waterborne giardiasis at a mountain resort: evidence for acquired immunity, Am. J. Public Health, 74 (6): 602-604 (1984).
17. den Hollander, et al. Immunology of Giardiasis. Parasitiology Today. 4: 124-130 (1988).
18. Adam. The biology of
Giardia spp.
Microbiology Reviews. 55: 706-732 (1991).
19. Roberts-Thomson, et al. Acquired resistance to infection in an animal model of giardiasis. J. Immunology. 117: 2036-2037 (1976).
20. LoGalbo, et al. Symptomatic giardiasis in three patients with X-linked agammaglobulinemia. J. Pediat. 101: 78-80 (1982).
21. Janoff, et al. Acute antibody responses to
Giardia lamblia
are depressed in patients with AIDS. J. Infect. Dis. 157: 798-804 (1988).
22. Butscher, et al. The therapeutic action of monoclonal antibodies against surface glycoprotein of
Giardia muris
. Immunology. 64: 175-180 (1988).
23. Stevens, et al. Local immunity in murine giardiasis: is milk protective at the expense of the maternal gut? Trans. Assoc. Am. Phys. 91: 268-272 (1978).
24. Roberts-Thomson, et al. Protection of mice against
Giardia muris
infection. Infect. Immun. 24:971-973 (1979).
25. Smith, et al. Chronic giardiasis: studies on the drug sensitivity, toxin production, and host immune response. Gastroenterology. 83: 797-803 (1982).
26. Katelaris, et al. Diarrhea and malabsorption in giardiasis: a multifactorial process? Gut. 33: 295-297 (1992).
27. Nash, et al. Excretory-secretory products of
Giardia lamblia.
J. Immunology. 131: 2004-2010 (1983).
28. Katelaris, et al. Pathogenesis of diarrhea caused by
Giardia lamblia:
evidence for an exotoxin. J. Gastroenterol. Hepatol. 3(suppl 1): A4 (1988).
29. Zaman, Dextran particles as a carrier for
Giardia lamblia
for scanning electron microscopy, J. Electron. Microsc. 41: 179-180 (1992).
30. Kirkpatrick, et al., Feline giardiasis, observations on natural and induced infections, Am. J. Vet. Res., 45:2182-2188 (1984).
The disclosure of the above publications and patents are herein incorporated by reference in their entirety to the same extent as if the language of each individual publication or patent were specifically and individually included herein.
BACKGROUND OF THE INVENTION
Intestinal protozoa are the cause of many human and animal diseases. When they infect domestic animals, severe economic losses may result. Intestinal protozoa of importance include cryptosporidium, trichomonads, histamonas, spironucleus, entamoeba, coccidia, toxoplasma and sarcocystis. One of the most problematic intestinal protozoa is Giardia.
Giardia lambia
is the most commonly found pathogenic parasite in western countries and is endemic in much of North America. Giardia is a flagellated protozoan which is transmitted through the fecal-oral route
2
. The mechanism of pathogenesis in Giardia is poorly understood but it results in symptoms similar to many other gastrointestinal ailments. The most common symptoms are diarrhea, anorexia, malaise, abdominal distention and flatulence. Acute stages of the infection usually last only a few days although occasionally, especially in children, the chronic stage may last for months
3
.
Once inside its host, the Giardia trophozoites attach to the epithelium of host intestinal villi where they multiply, become encysted, and then are shed in the host feces. Some infected hosts become asymptomatic cyst passers after the short acute stage of the infection has passed
4
.
A major source of Giardia infection is contaminated drinking water. This has earned it the name “backpackers diarrhea” because of the large number of people infected due to exposure to contaminated water when camping
4
. Outbreaks of giardiasis are also a frequent problem in day care centers. Recurring Giardia infections in day care centers are common, and many of the children are found to be carriers of the infection although they show no symptoms. This makes detection and effective treatment of Giardia in day care centers difficult
5
.
A major area of interest in Giardia infections is the ability of animal hosts to act as reservoirs for human infective strains of Giardia. There is evidence that inter-species transmission of Giardia can and does occur. Human strains of Giardia have been shown to be infective in gerbils, mice, guinea pigs, raccoons, and beavers
6-8
. The common name given to Giardia infection in Canada, “beaver fever”, was born when an epidemic of the infection resulted from the contamination of a water source by a family of three beavers
9
. Giardia infections are common in dogs and cats. It is estimated that 10-68% of dogs and 25% of cats are infected with Giardia. Studies of the prevalence of Giardia infection in domestic ruminants found infection in 17.7% of sheep and 10.4% of cattle, with the incidence being higher in lambs (35.6%) and calves (27.7%)
10
.
As previously stated, clinical giardiasis may range from asymptomatic carriage of the parasite to an illness characterized by diarrhea, abdominal cramps, headache, gas, bloat, dehydration and malaise
1,11
. Weight loss and retardation of growth are also common problems associated with giardiasis in humans and animals
11
.
In humans, histological changes associated with Giardia include villus atrophy
2
. More recent studies using
Mongolian gerbils
as an animal model have shown diffuse shortening of the microvillus mainly in the duodenum as well as a decrease in the brush border enzyme activity. The enzyme deficiencies may be caused by the shortening of the epithelial microvilli
12
. Other studies have correlated Giard
Ceri Howard
Morck Douglas W.
Olson Merle E.
Burns Doane , Swecker, Mathis LLP
Stucker Jeffrey
University Technologies International Inc.
Winkler Ulrike
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