EP0109688A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Improved complexes, processes for obtaining them and formulations containing such complexes
Assignee: Wellcome Foundation Ltd
•
Filing: 1983-11-21
•
Granted: —
•
Expires: 2003-11-21
Abstract
Abstract @ The invention provides an antigenic composition substantially free from cells and lipopolysaccharide, the said composition comprising a complex having a polysaccharide constituent and a protein constituent, wherein the polysaccharide constituent comprises capsular polysaccharide specific to serogroup B of N. meningtidis, and the protein constituent comprises N. meningitidis outer-membrane protein selected from the class consisting of those proteins specific to serotype 6, those proteins specific to serotype 2 and having a single dominant component having a molecular weight of 42,000 ± 3,000, and immunological equivalents of such proteins. Preferably the composition also comprises a pharmacologically acceptable metal either as an adjuvant in admixture with the polysaccharide-protein complex, or in complex therewith to provide a triple metal-polysaccharide- protein complex. The composition is useful for the prophylaxis or treatment of bacterial disease in mammals such as man.
Inventors
- 👤 Carlos Moreno
- 👤 Mark Robert Lifely
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 14:17
CPC Classifications
A; A61; A61K; A61K39/00; A61K39/02; A61K39/095; Y; Y10; Y10S; Y10S530/00; Y10S530/806; Y10S530/82; Y10S530/825
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
85 words
1) An antigenic composition substantially free from cells and lipopolysaccharide, the said composition comprising a complex having a polysaccharide constituent and a protein constituent, wherein the polysaccharide constituent comprises capsular polysaccharide specific to serogroup B of N. meningitidis, and the protein constituent comprises N. menigitidis outer-membrane protein selected from the class consisting of those proteins specific to serotype 6, those proteins specific to serotype 2 and having a single dominant component having a molecular weight of 42,000 ! 3,000, and immunolgical equivalents of such proteins.
Claim 2
Dependent Claim
85 words
1) An antigenic composition substantially free from cells and lipopolysaccharide, the said composition comprising a complex having a polysaccharide constituent and a protein constituent, wherein the polysaccharide constituent comprises capsular polysaccharide specific to serogroup B of N. meningitidis, and the protein constituent comprises N. menigitidis outer-membrane protein selected from the class consisting of those proteins specific to serotype 6, those proteins specific to serotype 2 and having a single dominant component having a molecular weight of 42,000 ! 3,000, and immunolgical equivalents of such proteins.
Claim 3
Dependent Claim
19 words
2) An antigenic composition as claimed in claim 1, the said composition further comprising a pharmacologically acceptable metal ingredient.
Claim 4
Dependent Claim
57 words
3) An antigenic composition as claimed in claim 2, wherein the pharmacologically acceptable metal ingredient is present in the form of a further constituent of the complex, the said complex thus comprising a polysaccharide constituent as defined in claim 1, a protein constituent as defined in claim 1 and a further constituent comprising a pharmacologically acceptable metal.
Claim 5
Dependent Claim
24 words
4) An antigenic composition as claimed in claim 2, wherein the pharmacologically acceptable metal ingredient is present in admixture with the said polysaccharide-protein complex.
Claim 6
Dependent Claim
38 words
5) An antigenic composition as claimed in any of claim 2-4, wherein the pharmacologically acceptable metal ingredient is selected from pharmacologically acceptable metals in groups IIA, IB, IIB and IIIB of the periodic table, and the transition metals.
Claim 7
Dependent Claim
26 words
6) An antigenic composition as claimed in any of claims 2-5, wherein the pharmacolgically acceptable metal ingredient is selected from aluminium, zinc, iron, nickel and calcium.
Claim 8
Dependent Claim
25 words
7) An antigenic composition as claimed in any of claims 2-6, wherein the pharmacolgically acceptable metal ingredient is in the form of a metal ion.
Claim 9
Dependent Claim
16 words
8) An antigenic composition as claimed in any of claims 2-7, wherein the metal is aluminium.
Claim 10
Dependent Claim
18 words
9) An antigenic composition as claimed in claim 7, wherein the metal ion is the Al 3+ ion.
Claim 11
Dependent Claim
34 words
10) An antigenic composition as claimed in any preceding claim, wherein the protein constituent comprises N. meningitidis outer-membrane selected from the class consisting of those proteins specific to serotype 6 and immunological equivalents thereof.
Claim 12
Dependent Claim
49 words
11) An antigenic composition as claimed in any preceding claim, wherein the protein constituent comprises N. meningtidis outer-membrane protein selected from the class consisting of those proteins specific to serotype 2 and having a single dominant component having a molecular weight of 42,000 ± 3,000, and immunological equivalents thereof.
Claim 13
Dependent Claim
31 words
12) An antigenic composition as claimed in claim 1, wherein the polysaccharide-protein complex has a molecular weight of at least 2 x 10 7 when determined by chromatography on Sepharose CL-2B.
Claim 14
Dependent Claim
27 words
13) An antigenic composition as claimed in claim 10, wherein the ratio of polysaccharide to protein in the said complex is between 0.2:1 w/w and 5:1 w/w.
Claim 15
Dependent Claim
27 words
14) An antigenic composition as claimed in claim 11, wherein the ratio of polysaccharide to protein in the said complex is between 0.2:1 w/w and 10:1 w/w.
Claim 16
Dependent Claim
32 words
15) An antigenic composition according to any preceding claim, the said composition further comprising at least one other complex comprising meningococcal capsular polysaccharide, meningococcal outer-membrane protein, and optionally a pharmacologically acceptable metal.
Claim 17
Dependent Claim
152 words
16) A process for the isolation of a complex of a bacterial capsular polysaccharide and a bacterial outer-membrane protein, the proccus comprising the steps: (i) culturing in a medium, a bacterium which possesses an outer-membrane and capsule and obtaining an aqueous phase which includes a complex of a bacterial capsular polysaccharide and a bacterial outer-membrane protein; (ii) admixing the aqueous phase obtained in step (i) with a quaternary ammonium salt, to effect precipitation of a precipitate containing the said complex; (iii) admixing the precipitate obtained in step (ii) with a water-soluble salt of calcium or magnesium in an aqueous medium to form an aqueous solution which includes said complex as a solute; (iv) admixing the aqueous solution obtained in step (iii) with a lower alkanol, to effect precipitation of a precipitate containing the said complex; and (v) separating the complex from any other components present in the precipitate resulting from step (iv).
Claim 18
Dependent Claim
152 words
16) A process for the isolation of a complex of a bacterial capsular polysaccharide and a bacterial outer-membrane protein, the proccus comprising the steps: (i) culturing in a medium, a bacterium which possesses an outer-membrane and capsule and obtaining an aqueous phase which includes a complex of a bacterial capsular polysaccharide and a bacterial outer-membrane protein; (ii) admixing the aqueous phase obtained in step (i) with a quaternary ammonium salt, to effect precipitation of a precipitate containing the said complex; (iii) admixing the precipitate obtained in step (ii) with a water-soluble salt of calcium or magnesium in an aqueous medium to form an aqueous solution which includes said complex as a solute; (iv) admixing the aqueous solution obtained in step (iii) with a lower alkanol, to effect precipitation of a precipitate containing the said complex; and (v) separating the complex from any other components present in the precipitate resulting from step (iv).
Claim 19
Dependent Claim
21 words
17) A process as claimed in claim 16 when used to prepare a complex as defined in any of claims 1-15.
Claim 20
Dependent Claim
39 words
18) A process as claimed in claim 16, when used to prepare a complex as defined in any of claims 1-15, the process comprising a further step of bringing the said complex into association with a pharmacologically acceptable metal.
Claim 21
Dependent Claim
23 words
19) A vaccine formulation comprising an antigenic composition as claimed in any of claims 1-15, and at least one adjuvant and/or carrier therefor.
Claim 22
Dependent Claim
30 words
20) An antigenic composition as claimed in any of claims 1-15 for use in a method of treatment of a bacterial (eg. meningococcal) disease of a mammal such as man.
Claim 23
Dependent Claim
13 words
21) An antigenic composition has hereinbefore described with reference to the accompanying drawings.
Claim 24
Dependent Claim
13 words
21) An antigenic composition has hereinbefore described with reference to the accompanying drawings.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
Maintenance schedule is calculated for granted US utility patents.