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US4451446A
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US
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Process for the preparation of polysaccharide-protein complexes from bacterial capsules, obtained products and immunogenic compositions containing them
Assignee: SmithKline RIT
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Filing: 1982-03-04
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Granted: 1984-05-29
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Expires: 2002-03-04
Abstract
Abstract Process for the non-degrading preparation of polysaccharide-protein complexes from bacterial capsules; the so-obtained products which are useful as vaccines against infection by the same bacteria and method for protecting human beings against the same infection by administration of pharmaceutical composition containing the polysaccharide-protein complexes.
Inventors
- 👤 Jean Vandevelde
- 👤 Robert De Neys
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 15:21
CPC Classifications
A; A61; A61K; A61K39/00; A61K39/02; A61K39/102; A61K39/095; A61K2039/62; A61K2039/622; Y; Y10; Y10S; Y10S424/00; Y10S424/831; Y10S530/00; Y10S530/806; Y10S530/82; Y10S530/825
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
110 words
A process for preparing immunogenic lipopolysaccharide-free bacterial capsular polysaccharide-protein noncovalent complex from bacteria suspended in an aqueous medium which comprises inactivation of the bacteria by the addition of a quaternary ammonium salt immediately followed by collection of the insoluble fraction, take-up with a 0.2 to 2 N aqueous solution of a non toxic alkali- or alkaline-earth metal salt, precipitation of contaminants by addition of 5 to 40% (vol/vol) of a water-miscible alcohol, removal of the quaternary ammonium salt from the solution by addition of a water soluble iodide, sulfocyanide or benzoate and separation of the precipitate to yield an aqueous solution from which the immunogenic lipopolysaccharide-protein noncovalent complex is isolated.
Claim 2
Dependent Claim
110 words
A process for preparing immunogenic lipopolysaccharide-free bacterial capsular polysaccharide-protein noncovalent complex from bacteria suspended in an aqueous medium which comprises inactivation of the bacteria by the addition of a quaternary ammonium salt immediately followed by collection of the insoluble fraction, take-up with a 0.2 to 2 N aqueous solution of a non toxic alkali- or alkaline-earth metal salt, precipitation of contaminants by addition of 5 to 40% (vol/vol) of a water-miscible alcohol, removal of the quaternary ammonium salt from the solution by addition of a water soluble iodide, sulfocyanide or benzoate and separation of the precipitate to yield an aqueous solution from which the immunogenic lipopolysaccharide-protein noncovalent complex is isolated.
Claim 3
Dependent Claim
14 words
A process according to claim 1 wherein the bacteria is Haemophilus influenzae type b.
Claim 4
Dependent Claim
14 words
A process according to claim 1 wherein the bacteria is Neisseria meningitidis group B.
Claim 5
Dependent Claim
14 words
A process according to claim 1 wherein the aqueous medium is whole fermentation broth.
Claim 6
Dependent Claim
14 words
A process according to claim 1 wherein the quaternary ammonium salt is cetrimonium bromide.
Claim 7
Dependent Claim
14 words
A process according to claim 1 wherein the nontoxic metal salt is calcium chloride.
Claim 8
Dependent Claim
17 words
A process according to claim 1 wherein the amount of water-miscible alcohol is 25% (vol/vol) of ethanol.
Claim 9
Dependent Claim
16 words
A process according to claim 1 wherein the water soluble iodide is an alkali metal salt.
Claim 10
Dependent Claim
19 words
A process according to claim 1 wherein the isolation from the aqueous solution is performed by ultrafiltration and lyophilisation.
Claim 11
Dependent Claim
96 words
An immunogenic lipopolysaccharide-free capsular polysaccharide-protein noncovalent complex of Haemophilus influenzae type b prepared by the process of claim 1 wherein the polysaccharide moiety is polyribosylribitol phosphate and wherein the protein moiety presents one methionine residue per molecule and which, when tested by sodium dodecyl sulfate polyacrylamide gel electrophoresis, shows two spots corresponding to 90 and 10% (wt/wt) of polypeptides accounting for the protein present in the complex, the main fraction being hydrophobic and of a molecular weight of 41,000 daltons, the total amount of protein in the complex being at least 30% of the complex weight.
Claim 12
Dependent Claim
20 words
A complex according to claim 10 wherein the protein content is comprised between 40 and 90% (wt/wt) of the complex.
Claim 13
Dependent Claim
20 words
A meningitis vaccine comprising an effective dose of the polysaccharide-protein complex of claim 10 in freeze-dried form with a stabilizer.
Claim 14
Independent Claim
32 words
A method for inducing active immunization against infection by Haemophilus influenzae type b in humans which comprises administering an effective amount of the polysaccharide-protein complex of any of claims 10 and 11.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1987-05-29 | 1987-11-28 | 1988-05-29 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-05-29 | 1991-11-28 | 1992-05-29 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-05-29 | 1995-11-28 | 1996-05-29 | $7700.00 | Window Closed / Lapsed |