Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K39/02—Bacterial antigens
  • A61K39/05—Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K39/02—Bacterial antigens
  • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
  • A61K39/092—Streptococcus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P11/00—Drugs for disorders of the respiratory system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
  • A61P15/06—Antiabortive agents; Labour repressants
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
  • A61K2039/52—Bacterial cells; Fungal cells; Protozoal cells
  • A61K2039/522—Bacterial cells; Fungal cells; Protozoal cells avirulent or attenuated
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K39/00—Medicinal preparations containing antigens or antibodies
  • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
  • A61K2039/541—Mucosal route
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S424/00—Drug, bio-affecting and body treating compositions
  • Y10S424/82—Viral vaccine for equine species, e.g. horses
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S424/00—Drug, bio-affecting and body treating compositions
  • Y10S424/829—Bacterial vaccine for equine species, e.g. horses

Definitions

• the present invention relates to the use of bacteria for the manufacture of vaccines.
• Vaccination has been proven through the years to be a very efficient method for the prevention of diseases caused by many different bacteria.
• Vaccines have the advantage, contrary to e.g. antibiotic or pharmacochemical therapies, that they are preventing disease rather than curing it.
• vaccination is a standard routine.
• all animals in a group are vaccinated as a precautionary measure, in order to prevent disease, whereas in practice often only a few animals would have become infected if no vaccine had been given. This explains why for most commonly used vaccines adverse local reactions due to vaccination are not acceptable: it is not acceptable to cause (severe) physical stress in many animals to prevent a (mild) disease in few.
• Systemic application comprises all applications in which the vaccine is not applied to the mucosa (mucosal application comprises i.a. oral and intranasal vaccination).
• Systemic application routes comprise i. a. intramuscular application (IM), subcutaneous application (SC), intradermal vaccination (ID), intravenous vaccination (IV) and intraperitoneal vaccination (IP).
• this embodiment of the invention relates to the use of live attenuated bacteria for the manufacture of a vaccine for submucosal administration.
• Mucosal tissue is found i.a. in the mouth, the nose, the lining of the gut, the eye, the vulva and the lips.
• Submucosal application is understood to be administration through the upper layer of the mucosa, and into the submucosa.
• the submucosa is a well-defined layer, known as such in the art.
• there is no limit to depth at which vaccination takes place i.e. the depth of the tip of the needle
• the proviso that vaccination takes place in the submucosa In practice however, the vaccine would not likely be applied deeper than about 5 millimetres from the surface of the mucosa.
• smaller distances between the mucosa and the injection site gives smaller local effects.
• a very suitable depth would be in the submucosa between two and four millimetres below the mucosa.
• Another attractive way of application is by using a so-called needle-less injector.
• the use of these injectors is known from intradermal applications, but these injectors are equally suitable for submucosal applications. Due to the softness of mucosal tissue the vaccine, when applied through a needle-less injector, goes straight through the mucosa and will come to a halt in the submucosal tissue. The depth of the vaccination only depends on the power applied during administration.
• the live attenuated bacteria are used for the manufacture of a vaccine for administration in the submucosa of the labiae.
• Streptococcus equi the cause of “Strangles”. This disease causes abscesses of lymph nodes of head and neck and systemic infections. The swelling of the lymph nodes causes the horses to be suffocated. No reliable vaccine without adverse local reactions is known so far, Streptococcus zooepidemicus , causing respiratory tract infections and pneumonia, opportunistic infections and abortion in horses, Rhodococcus equi , causing bronchopneumonia with abscesses and intestinal abscesses, Corynebacterium pseudotuberculosis , causing pectoral abscesses and ulcerative lymphangitis, Pseudomonas mallel , causing: “Glanders”, a disease characterised by pyogranulomatous inflammations, nodular lesions in lung and ulcerative and nodular lesions in skin and respiratory mucosa, Actinobacillus equili , a well-known cause
• Horses have in many cases both a high emotional and economical value to their owners, Especially in the field of thoroughbreds, it would be unacceptable to have horses suffering from abscesses after vaccination.
• the use relates to a use where the live attenuated bacterium is an attenuated form of a horse pathogenic bacterium.
• the live attenuated bacterium is selected from the group of bacteria comprising Streptococcus equi, Streptococcus zooepidemicus, Rhodococcus equi, Corynebacterium pseudotuberculosis, Pseudomonas mallel, Actinobacillus equili and Pasteurella multocida.
• the live attenuated bacterium is of the species Streptococcus equi and/or Streptococcus zooepidemicus.
• the invention is equally applicable to a live attenuated bacterium that is an attenuated form of a bacterium that is pathogenic for cattle.
• the invention also applies to a live attenuated bacterium that is an attenuated form of a bacterium that is pathogenic for pigs.
• Streptococcus suis causing polyserositis, Staphylococcus aureus causing exudative epidermitis, Actinobacillus pleurnopneumoniae causing pleuropneumonia, Pasteurella multocida causing atrophic rhinitis and pneumonia, Bordetella bronchiseptica also causing atrophic rhinitis and pneumonia, Escherichia coli causing diarrhoea and edema disease, Clostridium perfringens as a cause of diarrhoea and septicaemia, Salmonella cholerasuis also a known cause of diarrhoea, Haemophilus parasuis also known as the cause of “Glassers disease”, Erysipelothrix rhusiopathiae causing a disease known as “Erysipelas”, Mycoplasma hyopneumoniae causing pneumonia
• the invention applies to a live attenuated bacterium that is an attenuated form of a bacterium that is pathogenic for dogs.
• bacteria are inter alia the following bacterial dog pathogens:
• the manufactured vaccines comprise at least an immunogenically effective amount of a live attenuated bacterium.
• Immunogenically effective means that the amount of live attenuated bacterium administered at vaccination is sufficient to induce in the host an effective immune response to virulent forms of the bacterium.
• the useful dosage to be administered will vary depending of age, weight and mammal to be vaccinated and the type of pathogen against which vaccination is sought.
• the vaccine may comprise any dose of bacteria sufficient to evoke an immune response. Doses ranging between 10 3 and 10 10 bacteria are e.g. very suitable doses.
• the manufactured vaccine also contains a pharmaceutically acceptable carrier.
• a pharmaceutically acceptable carrier may be as simple as water, but it may e.g. also comprise culture fluid in which the bacteria were cultured.
• Another suitable carrier is e.g. a solution of physiological salt concentration.
• pharmaceutically acceptable carriers or diluents useful in the present invention include stabilisers such as SPGA, carbohydrates (e.g. sorbitol, mannitol, starch, sucrose, glucose, dextran), proteins such as albumin or casein, protein containing agents such as bovine serum or skimmed milk and buffers (e.g. phosphate buffer).
• Adjuvants are non-specific stimulators of the immune system. They enhance the immune response of the host to the invading pathogen.
• adjuvants known in the art are Freunds Complete and Incomplete adjuvants, vitamin E, non-ionic block polymers, muramyldipeptides, ISCOMs (immune stimulating complexes, cf. for instance European Patent EP 109942), Saponins, mineral oil, vegetable oil, and Carbopol (a homopolymer).
• Other suitable adjuvants are for example aluminium hydroxide, phosphate or oxide, oil-emulsions (e.g. of Bayol F (R) or Marcol 52 (R) , saponins or vitamin-E solubilisate.
• a volume of 200 ⁇ I of the vaccine, comprising 10 8.8 bacteria was given at each spot.
• Three other horses were vaccinated subcutaneously in the same way, but with a double mutant: strain TW 928/sls comprising 10 8.2 bacteria in Diluvac Forte.
• the intramuscularly vaccinated horses developed large abscesses from the fourth day after vaccination, that grew to an average size, at ten days after vaccination, of about 20 centimetres diameter. These abscesses were persistent.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Medicinal Chemistry (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Pharmacology & Pharmacy (AREA)
• Mycology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• General Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Organic Chemistry (AREA)
• Immunology (AREA)
• Engineering & Computer Science (AREA)
• Epidemiology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Microbiology (AREA)
• Communicable Diseases (AREA)
• Pregnancy & Childbirth (AREA)
• Endocrinology (AREA)
• Reproductive Health (AREA)
• Gynecology & Obstetrics (AREA)
• Dermatology (AREA)
• Pulmonology (AREA)
• Oncology (AREA)
• Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
• Micro-Organisms Or Cultivation Processes Thereof (AREA)

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• 2000
  • 2000-01-20 ES ES00200216T patent/ES2214217T3/es not_active Expired - Lifetime
  • 2000-01-20 EP EP00200216A patent/EP1023903B1/de not_active Expired - Lifetime
  • 2000-01-20 PT PT00200216T patent/PT1023903E/pt unknown
  • 2000-01-20 AT AT00200216T patent/ATE257713T1/de not_active IP Right Cessation
  • 2000-01-20 DE DE60007668T patent/DE60007668T2/de not_active Expired - Lifetime
  • 2000-01-20 DK DK00200216T patent/DK1023903T3/da active
  • 2000-01-20 JP JP2000011573A patent/JP4339978B2/ja not_active Expired - Fee Related
  • 2000-01-25 AU AU13557/00A patent/AU761515B2/en not_active Ceased
  • 2000-01-25 CA CA002296965A patent/CA2296965A1/en not_active Abandoned
• 2003
  • 2003-12-08 US US10/731,724 patent/US20040120970A1/en not_active Abandoned
• 2010
  • 2010-12-01 US US12/957,543 patent/US8084040B2/en not_active Expired - Fee Related

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