Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Patent
1996-03-14
1998-05-12
Housel, James C.
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
43525233, 4352521, A61K 3902
Patent
active
057501181
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a vaccine against haemorrhagic dysentery of pigs (swine disentery) and to a vaccination kit using this vaccine as well as to a process for treating pigs against this disease.
The organism responsible for the haemorrhagic dysentery syndrome is Serpulina hyodysenteriae (formerly Treponema hyodysenteriae). 9 serotypes are currently recognized, identified mainly in the U.S.A., but also in Mexico, in England, in Denmark, in Holland, in Australia (Mapother and Joens classification, J. Clin. Microbiol, 1985, 22, 161-164) and recently in Canada for serotypes 8 and 9 (Z. Li, J. Clin. Microbiol, 1991, 29, 2794-2797; 1992, 30 (11), 2941-2947).
Numerous vaccination trials have been carried out until now. While it has been possible to demonstrate the feasibility of a vaccine through various trial models, few products have been exploited in the field because of lack of efficacy and problems of safety.
The vaccine options which have been the subject of previous research studies, or which are the subject of current research studies, cover the whole range of possibilities in respect of vaccines, namely: conventional vaccines,
U.S. Pat. No. 4,100,272 has thus proposed a killed cell vaccine for parenteral administration, which should result in partial or total immunizations via the systemic route. U.S. Pat. No. 4,152,413 has proposed an oral vaccine comprising enteric capsules containing killed cells for the liberation of active ingredients in the intestines; same approach in U.S. Pat. No. 4,152,414 and U.S. Pat. No. 4,203,968 where S. hyodysenteriae is combined with killed Bacteroides vulgatus or Furobacterium necrophorium cells. U.S. Pat. No. 4,152,415 proposes a parenteral administration of a killed cell vaccine followed by oral administration of a vaccine in enteric capsules. Patent U.S. Pat. No. 4,203,968 proposes a parenteral preparation containing killed S. hyodysenteriae cells and killed Bacteroides vulgatus cells and also proposes combining it with an oral formulation. U.S. Pat. No. 4,469,672 and U.S. Pat. No. 4,748,019 propose vaccinating by administering killed cells parenterally, and then orally. Patent Application EP-A-201,796 describes a process for culturing S. hyodysenteriae in a nutritive medium containing a cholesterol-rich bovine fraction for producing an inactivated vaccine formulated in the form of an emulsion with an adjuvant consisting of polyacrylic acid and polysaccharide in cross-linked form. According to this document, a resistance could be obtained after two intramuscular injections, whereas known vaccines require several intravenous injections. Finally, European Patent Application EP-A-339 040 proposes administering parenterally live cells and killed cells in the presence of oxygen.
None of these approaches have permitted the production of an effective vaccine.
The Taylor strain (1972), attenuated by 80 passages on horse blood agar, is also known whose efficacy was explored by oral vaccination at repeated doses of the order of 5.times.10.sup.9 CFU at 9 weeks of age (Hudson, Br. Vet. J. 1974, 130, 37-40 and Res. Vet. Sci. 1976, 21, 366-367). This vaccine showed only a limited efficacy.
The so-called spontaneously attenuated VS1 strain, of Lysons of the British Technology Group (strain NCTC 11628) has also been used, and at repeated doses of 10.sup.8 CFU, in combination with 2 injections of an inactivated formulation, with oil adjuvant (strain P18A, NCTC 11615, dose of 5.times.10.sup.9 CFU).
A solution currently recommended for producing an attenuated live vaccine is to delete from the bacterium its virulent factors, leaving the chromosome only with its functions for the survival of the bacterium (M. B. Koopman, Infect. Immun. 1992, 60, 2920-2925).
The failure of the conventional vaccine approach has recently been confirmed by J. P. TRONEL (Thesis, National Veterinary School of Lyon: "Contribution to the study and development of a vaccine against haemorrhagic dysentery of pigs", made public on 17 Feb. 1993). The inactivated vaccines tested exhibited the disadvantage
REFERENCES:
patent: 4758517 (1988-07-01), Parizek
patent: 4868118 (1989-09-01), Norgard
Clin, J. et al, J. cell Biochem Suppl o(17 part C) 1993, 54.
Pig Products and Research Highlights, Animal-Pharm, vol. 259, p. 16, 920901 .
Guillaud Marc Jean
Milward Francis William
Vandeputte Joris Frans
Frommer William S.
Housel James C.
Kowalski Thomas J.
Portner Ginny Allen
Rhone Merieux
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