Injectable vaccines against multiple meningococcal serogroups
AssigneeGlaxosmithkline Biologicals SA
InventorPaolo COSTANTINO
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Abstract
An injectable immunogenic composition comprising capsular saccharides from at least two of serogroups A, C, W135 and Y of Neisseria meningitidis, wherein said capsular saccharides are conjugated to carrier protein(s) and/or are oligosaccharides, and wherein (i) the composition comprises <50 μg meningococcal saccharide per dose, and/or (ii) the composition further comprises an antigen from one or more of: (a) serogroup B N.meningitidis; (b) Haemophilus influenzae type B; and/or (c) Streptococcus pneumoniae. Saccharide antigens in the compositions are generally conjugated to a carrier.
Claims28
1-25. (canceled)
26:
- An injectable immunogenic composition comprising capsular saccharides from at least three serogroups A, C, W135 and Y of Neisseria meningitidis, wherein the capsular saccharides are oligosaccharides and are conjugated to one or more carrier proteins, and wherein the composition comprises less than 50 ug meningococcal saccharide per dose.
27:
- An injectable immunogenic composition comprising capsular saccharides from at least three serogroups A, C, W135 and Y of Neisseria meningitidis, wherein:
- the capsular saccharides are oligosaccharides and are conjugated to one or more carrier proteins, and wherein the composition further comprises an antigen from one or more of (a) serogroup B Neisseria meningitidis;
- (b) Haemophilus influenza type B;
- and (c) Streptococcus pneumoniae.
28:
- The composition of claim 26 or claim 27, comprising antigens that protect against serogroups C, W135 and Y of Neisseria meningitidis.
29:
- The composition of claim 28, further comprising an antigen that protects against serogroup A of Neisseria meningitidis.
30:
- The composition of claim 29, wherein the antigen that protects against serogroup A of Neisseria meningitidis is a modified serogroup A capsular saccharide in which one or more hydroxyl groups have been replaced with blocking groups.
31:
- The composition of claim 28, further comprising an antigen that protects against Haemophilus influenza type B.
32:
- The composition of claim 28, further comprising one or more antigens that protect against serogroup B of Neisseria meningitidis.
33:
- The composition of claim 32, where the one or more antigens can induce, after administration to a subject, a bacterial antibody response in that subject against two or more of hypervirulent lineages A4, ET5 and lineage 3 of Neisseria meningitidis serogroup B.
34:
- The composition of claim 32, wherein the one or more antigens comprise one or more of (a) a NadA protein in oligomeric form;
- (b) a 741 protein;
- (c) a 936 protein;
- (d) a 953 protein;
- and (e) a 287 protein.
35:
- The composition of claim 34, wherein the one or more antigens comprise (a) a NadA protein in oligomeric form;
- (b) a 741 protein;
- (c) a 936 protein;
- (d) a 953 protein;
- and (e) a 287 protein.
36:
- The composition of claim 34, comprising a first polypeptide comprising amino acid sequence SEQ ID NO:2, a second polypeptide comprising amino acid sequence SEQ ID NO:
- 7 and a third polypeptide comprising amino acid sequence SEQ ID NO:
- 8.
37:
- The composition of claim 28 further comprising one or more antigens that protect against Streptococcus pneumoniae.
38:
- The composition of claim 37, wherein the one or more antigens comprise a capsular saccharide from Streptococcus pneumoniae.
39:
- The composition of claim 38, comprising capsular saccharides from between 5 and 11 different serotypes of Streptococcus pneumoniae.
40:
- The composition of claim 37, wherein the one or more antigens comprise polypeptides from Streptococcus pneumoniae.
41:
- The composition of claim 40, wherein the composition comprises one or more of the Streptococcus pneumoniae antigens PhtA, PhtD, PhtB, PhtE, SpsA, LytB, LytC, LytA, Sp125, Sp101, Sp128 and Sp130.
42:
- The composition of claim 28, wherein saccharide antigens in the composition are conjugated to carrier proteins.
43:
- The composition of claim 42, wherein saccharide antigens in the composition are oligosaccharides conjugated to CRM197 protein, protein D of Haemophilus influenza, tetanus toxoid or diphtheria toxoid.
44:
- The composition of claim 42, wherein the conjugates have a saccharide:protein ratio (w/w) between 1:5 and 5:1.
45:
- The composition of claim 28 comprising less than 25 ug meningococcal saccharide per dose.
46:
- The composition of claim 28, further comprising an aluminum salt adjuvant.
47:
- A kit comprising lyophilized capsular saccharides from Neisseria meningitidis serogroup A and liquid capsular saccharides from Neisseria meningitidis serogroup C, W135 and Y
48:
- The kit of claim 47, wherein the capsular saccharides from Neisseria meningitidis serogroup A are modified serogroup A capsular saccharides in which one or more hydroxyl groups have been replaced with blocking groups.
49:
- A method of preparing the composition of claim 28 comprising mixing lyophilized capsular saccharides from Neisseria meningitidis serogroup A with liquid capsular saccharides from Neisseria meningitidis serogroup C, W135 and Y.
50:
- The method of claim 49, wherein the capsular saccharides from Neisseria meningitidis serogroup A are modified serogroup A capsular saccharides in which one or more hydroxyl groups have been replaced with blocking groups.
51:
- A method of generating an immune response in a human comprising injecting the human with the composition of claim 28.
52:
- A method of generating an immune response in a human comprising injecting the human with capsular conjugated oligosaccharides from serogroups A, C, W135 and Y of Neisseria meningitidis and one or more antigens chosen from serogroup B Neisseria meningitidis;
- Haemophilus influenza type B;
- and Streptococcus pneumoniae.