Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Patent
1986-11-12
1989-10-10
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
424 92, 424436, 424475, 424480, 424489, 424499, A61K 948, A61K 3902
Patent
active
048730904
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to an enteral monobacterial vaccine comprising killed Haemophilus influenza or Streptococcus pneumoniae, a process for the manufacture of such a vaccine and a method of preventing acute mucosal infections in humans having chronic mucosal disease by administering such a vaccine.
BACKGROUND ART
Acute episodes of bronchitis in cigarette smokers are a major health problem and are in particular a cause of morbidity and mortality with patients with chronic obstructive lung disease (COLD). The upper respiratory tract of these patients is commonly colonised with Haemophilus influenzae and/or Streptococcus pneumoniae, and it has been held that a shift in the shot-bacteria balance favouring infection with these organisms is the immediate cause of acute bronchitis. Children with cystic fibrosis commonly suffer from chronic infection by Pseudomonas aeruginosa and Staphylococcus aureus. Polybacterial vaccines containing a selection of killed bacteria normally associated with infection of the respiratory tract have been available for many years. The polybacterial vaccines contain an adjuvant of conventional type whose function according to established methodology is to enhance the response of the patient to the antigen thereby leading to enhanced immunity. The adjuvant may be a chemical agent. Alternatively, the variety of organisms themselves function in a non-specific way to activate the immune system. Such adjuvant-containing polybacterial vaccine has been commercially available in tablet form for oral digestion. The tablets are enteric coated to allow passage through the stomach, followed by stimulation of gut-associated lymphoid tissue. However, the effectiveness of these polybacterial vaccines has been disappointing in the treatment of acute bacterial infections of the respiratory tract in humans having chronic mucosal inflammations.
It is an object of the present invention to provide an enteral vaccine against infections of mucosal surfaces in humans having long term mucosal disease.
DISCLOSURE OF INVENTION
In a first aspect, the present invention provides an enteral monobacterial vaccine comprising killed bacteria for immunisation against bacterial infection of mucosal sites. Examples for such bacteria are Haemophilus influenzae. Streptococcus pneumoniae, Pseudomonas aeruginosa and Staphylococcus aureus. Preferred is a vaccine comprising killed Haemophilus influenzae. A particular aspect of the vaccine of the present invention is that no adjuvant is added to the killed bacteria, i.e. that the vaccine stimulates only a limited antigenic response. Adjuvants usually added to vaccines and absent in the vaccine of the present invention are killed bacteria known to illicit a strong antigenic response, e.g. killed Mycobacterium tuberculosis such as Bacillus Calmette-Guerin (BCG), or killed Corynebacterium parvum, a selection of closely related bacteria, whereby each species acts as an adjuvant for the other bacteria, or inorganic polymeric material, e.g. aluminium oxide or aluminum phosphate, which is useful especially in parenteral vaccines.
The enteric vaccine may be in the form of tablets, especially enteric coated tablets, granules, capsules or dragees for oral administration, or provided e.g. as suppositories for rectal administration. The dosage unit form may contain from approximately 10.sup.9 bacteria to approximately 10.sup.13 bacteria, preferably from approximately 10.sup.10 bacteria to approximately 10.sup.12 bacteria, together with suitable carriers of organic or inorganic nature.
Suitable carries are especially fillers, such as sugars, for example lactose, saccharose, mannitol or sorbitol, cellulose preparations and/or calcium phosphates, for example tricalcium phosphate or calcium hydrogen phosphate, amino acids, for example glycine, also binders, such as starch pastes using, for example, corn, wheat, rice or potato starch, gelatine, tragacanth, methylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone, and
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Infection and Immunity, vol. 39, No. 2, Feb. 1983, pp. 491-496 R. L. Clancy et al. "Specific Immune Response in the Respiratory Tract after Administration of an Oral Polyvalent Bacterial Vaccine", whole document.
Biological Abstracts, vol. 65, No. 2, 1978, no. 894, ref. 9268 J. R. Gerke et al.: "Oral Vaccination and Multivalent Vaccine Against Psuedomonas aeruginosa keratitis" & Invest. Ophthalmol. Vis. Sci, 16(1), 76-80, 1977-Abstract.
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Broncostat Pty. Limited
Page Thurman K.
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