Multivalent pneumococcal glycoconjugate vaccines containing emerging serotype 24F

Inventors

Kapre, Subhash V. • Datta, Anup K.

Assignees

Inventprise LLC

Abstract

The invention is directed to multivalent pneumococcal glycoconjugate compositions containing a newly emerging serotype of S. pneumonia, polysaccharide 24F, and their manufacture and use. The pneumococcal serotype 24F contains a polysaccharide repeating unit structure. The multivalent immunogenic composition comprises at least 25 S. pneumonia capsular polysaccharides selected from the serotypes 1, 2, 3, 4, 5, 6B, 6C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19A, 19F, 20, 22F, 23B, 23F, 24F, 33F and 35B of S. pneumoniae preferably conjugated to carrier protein either directly or through a linker and a pharmaceutically acceptable carrier and/or adjuvant. The disclosure provides the capsular polysaccharide structure of serotype 24F to understand the polysaccharide before conjugation with carrier protein.

Core Innovation

The disclosed invention relates to multivalent pneumococcal glycoconjugate vaccines that include newly emerging pneumococcal serotype 24F. The 24F serotype capsular polysaccharide is defined by a repeating unit having a chemical structure as set forth in the description, and the invention integrates the defined 24F capsular polysaccharide into an immunogenic composition containing at least 25 Streptococcus pneumoniae capsular polysaccharides from specified serotypes.

The immunogenic composition comprises capsular polysaccharides conjugated to one or more carrier proteins, where at least one conjugation is through a bi-functional or a multifunctional spacer/linker. The disclosed carrier proteins include CRM197 and other toxin/antigen carriers, either directly or through bi-/multifunctional spacers/linkers, thereby connecting multiple capsular polysaccharides to carrier proteins using defined spacer/linker functionality.

The description further provides characterization of the 24F capsular polysaccharide repeating-unit structure using NMR, HPAE-PAD, GC-MS, and linkage analysis, including HF treatment. The document also describes conjugated vaccine formulations with optional pharmaceutically acceptable carriers and adjuvants, including aluminum salts, MPLA, QS-21, and TLR7/8 agonists.

Claims Coverage

The patent contains one independent claim directed to a multivalent Streptococcus pneumoniae capsular polysaccharide immunogenic composition with a defined 24F repeating unit and carrier conjugation via bi-functional or multifunctional spacers/linkers. The dependent claims refine the conjugation and formulation by adding specific quantitative dosage ranges, selecting specific carrier protein options, and specifying optional pharmaceutically acceptable carriers and adjuvant classes.

Overall, claim coverage centers on a multivalent pneumococcal glycoconjugate immunogenic composition that includes serotype 24F with a defined repeating-unit structure and in which the specified capsular polysaccharides are conjugated to one or more carrier proteins using at least one bi-functional or multifunctional spacer/linker. Dependent claims further constrain and extend the formulation with specific carrier protein sets, optional pharmaceutically acceptable carriers and excipients, adjuvant classes, and quantitative polysaccharide dose ranges.

Stated Advantages

Documented Applications

No documented applications found