Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof
Inventors
Emini, Emilio Anthony • Watson, Wendy Jo • Prasad, Avvari Krishna • Han, Mingming • Kim, Jin-Hwan • Gu, Jianxin • Yang, Yu-Ying • Kainthan, Rajesh Kumar • Cooper, David • Pride, Michael William • Jansen, Kathrin Ute
Assignees
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Publication Number
US-12616744-B2
Publication Date
2026-05-05
Expiration Date
Abstract
The present invention relates to new immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens (glycoconjugates) and uses thereof. Immunogenic compositions of the present invention will typically comprise at least one glycoconjugate from a S. pneumoniae serotype not found in PREVNAR®, SYNFLORIX® and/or PREVNAR 13®. The invention also relates to vaccination of human subjects, in particular infants and elderly, against pneumococcal infections using said novel immunogenic compositions.
Core Innovation
The disclosure relates to pneumococcal conjugate immunogenic compositions comprising glycoconjugates of capsular polysaccharide antigens from Streptococcus pneumoniae. The composition is defined as a 21-valent immunogenic composition with capsular polysaccharide antigens from multiple specified serotypes, where the capsular polysaccharide of each serotype is individually conjugated to a carrier protein.
A central design element is the specific assignment of carrier proteins to defined serotype groups within the 21-valent composition, including CRM197 as the carrier protein for glycoconjugates comprising capsular polysaccharide from serotypes 8, 10A, 11A, 12F and 33F, and tetanus toxoid as the carrier protein for glycoconjugates comprising capsular saccharide from serotypes 15B and 22F. The composition is presented in the context of pneumococcal conjugate vaccine approaches such as PCVs, including PREVNAR, SYNFLORIX, and PREVNAR 13.
The document further describes structural and chemical features of glycoconjugates, including O-acetylation preservation and characterization, with parameters including molecular weight by SEC-MALLS, oxidation degree, acetate-to-polysaccharide amounts, free polysaccharide limits, and Kd distributions by SEC/CL-4B. These features support a defined immunogenic glycoconjugate profile.
Claims Coverage
The consolidated claims content includes one independent claim covering a 21-valent immunogenic composition with individually conjugated glycoconjugates from 21 specified Streptococcus pneumoniae serotypes, with carrier proteins assigned to specific serotype subsets. Dependent claims further refine serotype-to-carrier mappings and add quantitative quality constraints and composition amounts.
21-valent immunogenic composition with individually conjugated serotype-specific glycoconjugates
A 21-valent immunogenic composition comprising glycoconjugates of capsular polysaccharide from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to a carrier protein.
Serotype-to-carrier mapping using CRM197 and tetanus toxoid
The carrier protein of the glycoconjugates respectively comprising capsular polysaccharide of serotypes 8, 10A, 11A, 12F and 33F is CRM197, and the carrier protein of the glycoconjugates respectively comprising capsular saccharide of serotypes 15B and 22F is tetanus toxoid.
Specified carrier protein mapping for additional serotype subsets
The carrier protein of glycoconjugates comprising capsular polysaccharide of Streptococcus pneumoniae serotypes 3, 4, 6A, 6B, 9V, 14, 18C, 19A, 19F, and 23F is CRM197.
Specified tetanus toxoid assignment for serotypes 1 and 5
The carrier protein for glycoconjugates containing capsular polysaccharides from Streptococcus pneumoniae serotypes 1 and 5 is tetanus toxoid.
Free polysaccharide limitation for serotype 22F glycoconjugates
The glycoconjugates containing capsular polysaccharide from Streptococcus pneumoniae serotype 22F have less than 50% free polysaccharide.
Acetate-to-polysaccharide ratio constraint for serotype 33F glycoconjugates
The glycoconjugates containing Streptococcus pneumoniae serotype 33F capsular polysaccharide contain at least 0.1 mM acetate per 1 mM of the respective capsular polysaccharide.
Capsular saccharide per-serotype dosage-range constraint in multivalent composition
The multivalent immunogenic composition contains 2.0 µg to 5.0 µg of capsular saccharide from each Streptococcus pneumoniae serotype.
The claim coverage centers on a 21-valent immunogenic composition made of individually conjugated pneumococcal serotype capsular polysaccharides, with defined carrier proteins for selected serotype subsets. Dependent claims further refine the serotype-to-carrier assignments and add quantitative constraints including free polysaccharide limits, acetate-to-polysaccharide ratio, and capsular saccharide amounts per serotype.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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