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Multivalent pneumococcal polysaccharide-protein conjugate compositions and methods of use thereof

A technology for pneumococcus and pneumococcus, which can be used in drug combinations, multivalent vaccines, non-active components of polymer compounds, etc., and can solve problems such as the increase of virulent pneumococcal strains

Pending Publication Date: 2022-07-08
圣诺菲·帕斯图尔公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] While single-carrier and mixed-carrier glycoconjugate vaccines have been used to provide varying levels of protection against the pneumococcal serotypes contained in the vaccines, it has been observed that serotype substitution, or in the glycoconjugate vaccines The increase in the epidemic of strong toxic bacteria / serum types that are not included and this is still a problem

Method used

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  • Multivalent pneumococcal polysaccharide-protein conjugate compositions and methods of use thereof
  • Multivalent pneumococcal polysaccharide-protein conjugate compositions and methods of use thereof
  • Multivalent pneumococcal polysaccharide-protein conjugate compositions and methods of use thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0361] Example 1. Preparation of Streptococcus pneumoniae capsular polysaccharide

[0362] Cultivation of S. pneumoniae and purification of capsular polysaccharides are performed as known to those skilled in the art. S. pneumoniae serotypes were obtained from the American Type Culture Collection (ATCC) (Serotype 1: ATCC No. 6301; Serotype 3: ATCC No. 6303; Serotype 4: ATCC No. 6304; Serotype 5: ATCC No. 6305; Serotype 6A: ATCC No. 6306; Serotype 6B: ATCC No. 6326; Serotype 7F: ATCC No. 10351; Serotype 9N: ATCC No. 6309; Serotype 9V: ATCC No. 10368; Serotype 14: ATCC No. 6314; Serotype 18C: ATCC No. 10356; Serotype 19A: ATCC No. 10357; Serotype 19F: ATCC No. 6319; Serotype 23B: ATCC No. 10364; Serotype 23F: ATCC No. 6323). For serotypes 8, 10A, 11A, 12F, 15A, 15B, 15C, 22F, 23A, 23B, 24F, 33F, and 35B, internal strains or strains obtained from other sources were used, but any publicly available strain could be used. Streptococcus pneumoniae is characterized by capsular and mo...

Embodiment 2

[0369] Example 2. Conjugates of Streptococcus pneumoniae capsular polysaccharide and carrier protein (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, Preparation of 18C, 19A, 19F, 22F, 23F and 33F)

[0370] The polysaccharides of different serotypes are activated according to different pathways, and then combined with the carrier protein CRM 197 or TT conjugated. Specifically, serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 18C, Polyvalent pneumococcal polysaccharide-protein conjugates of capsular polysaccharides of 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B: serotypes 3, 4, 6A, 6B, 7F, 8, 9N, Each capsular polysaccharide and CRM of 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F 197 Each capsular polysaccharide of serotypes 1 and 5 was conjugated and conjugated to TT. Serotypes 15A, 15C, 23A, 23B, 24F and 35B and CRMs are described in Examples 3-8 197 conjugation. Compounds from serotypes 1, 3, 4, 5, 6A...

Embodiment 3

[0416] Example 3. Serotype 15A and CRM 197 Preparation of Single Conjugates

[0417] The serotype 15A polysaccharide can be purified as discussed above or with reference to the methods described in WO2013 / 191459 for the purification of polysaccharides of other serotypes. Acid hydrolysis was performed by applying acid and high temperature to purified serotype 15A polysaccharides as shown in Table 1, followed by an activation process. The conditions of hydrolysis were observed to affect the degree of oxidation (Do) and molecular weight of activated polysaccharides as well as conjugation results. The activation process and the conjugation process were performed under the same conditions. Sodium periodate was added and the oxidation reaction was allowed to proceed at 21 to 25°C for 16 to 20 hours. will activate polysaccharides and CRMs 197Proteins were lyophilized and suspended in DMSO. The activated polysaccharide and protein were mixed in a 1:1 ratio, and the reaction conce...

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Abstract

Provided is a multivalent pneumococcal conjugate composition comprising 22 to 27 different pneumococcal capsular polysaccharide-protein conjugates wherein each pneumococcal capsular polysaccharide-protein conjugate comprises a protein carrier conjugated to a capsular polysaccharide from a different serotype of Streptococcus pneumoniae, wherein the Streptococcus pneumoniae serotype is selected from the group consisting of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F, and 35B. Also provided are methods of producing the multivalent pneumococcal conjugate compositions and methods of using the multivalent pneumococcal conjugate compositions to prevent a Streptococcus pneumoniae infection or disease in a subject. Also provided are immunogenic compositions comprising at least one polysaccharide-protein conjugate, wherein the polysaccharide is a capsular polysaccharide from Streptococcus pneumoniae serotypes 15A, 15C, 23A, 23B, 24F and / or 35B; and methods of making the immunogenic compositions.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 949,164, filed on December 17, 2019, and Korean Patent Application No. 10-2019-0093276, filed on July 31, 2019, and relies on the filing dates of the above applications, the above The entire disclosure of the application is incorporated herein by reference. technical field [0003] This application generally relates to multivalent pneumococcal conjugate compositions, vaccines comprising said multivalent pneumococcal conjugate compositions, and the use of these compositions and vaccines to prevent Streptococcus pneumoniae infection in a subject or method of disease. Background technique [0004] Pneumococcus (Streptococcus pneumoniae) is a Gram-positive, lancet-shaped, facultative anaerobic bacterium with more than 90 known serotypes. Most S. pneumoniae serotypes have been shown to cause disease (eg, pneumonia, bacteremia, meningitis, and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/09
CPCA61K39/092A61K2039/6037A61K2039/622A61K2039/70A61P11/00A61P31/04A61P27/16A61K2039/55505A61K33/06A61K47/42
Inventor J·辛S·金H·金K·安J-M·李M·基奥P·塔拉加
Owner 圣诺菲·帕斯图尔公司
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