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Immunogenic compositions comprising conjugated capsular saccharide antigens, kits comprising the same and uses thereof

An immunogenicity and kit technology, applied in the direction of carrier-bound antigen/hapten components, medical preparations containing active ingredients, drug combinations, etc., can solve problems such as the complexity of multivalent vaccine development

Pending Publication Date: 2018-08-03
PFIZER INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The phenomenon of antigenic competition (or interference) complicates the development of multivalent vaccines

Method used

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  • Immunogenic compositions comprising conjugated capsular saccharide antigens, kits comprising the same and uses thereof
  • Immunogenic compositions comprising conjugated capsular saccharide antigens, kits comprising the same and uses thereof
  • Immunogenic compositions comprising conjugated capsular saccharide antigens, kits comprising the same and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[1727] Example 1: General method for preparing eTEC-linked glycoconjugates

[1728] Activation of sugar and thiolation with cystamine dihydrochloride

[1729] Reconstitute the sugar in dry dimethyl sulfoxide (DMSO). The moisture content of the solution is determined by Karl Fischer (KF) analysis and adjusted to achieve a moisture content of 0.1% to 0.4% (usually 0.2%).

[1730] To initiate activation, freshly prepared 1,1'-carbonyl-di-1,2,4-triazole (CDT) or 1,1'-carbonyldiimidazole (CDI) in DMSO at a concentration of 100 mg / mL Solution. Various amounts of CDT / CDI (1-10 molar equivalents) were used to activate the sugar, and the reaction was carried out at 23±2°C for 1 hour. The activation level can be determined by HPLC. Cystine dihydrochloride is freshly prepared at a concentration of 50 mg / mL in anhydrous DMSO. The activated sugar is reacted with 1 molar equivalent (mol.eq.) of cystamine dihydrochloride. Alternatively, the activated sugar is reacted with 1 molar equivalent...

Embodiment 2

[1750] Example 2: Preparation of Pn-33F eTEC conjugate

[1751] Activation method

[1752] Activation of Pn33F polysaccharide

[1753] Pn-33F polysaccharide was mixed with 500 mM 1,2,4-triazole (in WFI) to obtain 10 grams of triazole per gram of polysaccharide. The shell-frozen of the mixture was frozen in a dry ice-ethanol bath and then lyophilized to dryness. The lyophilized 33F polysaccharide was reconstituted in anhydrous dimethyl sulfoxide (DMSO). The moisture content of the lyophilized 33F / DMSO solution was determined by Karl Fischer (KF) analysis. The moisture content was adjusted to a moisture content of 0.2% by adding WFI to the 33F / DMSO solution.

[1754] To initiate activation, 1,1'-carbonyl-di-1,2,4-triazole (CDT) was freshly prepared at 100 mg / mL in DMSO solution. The Pn33F polysaccharide was activated with various amounts of CDT before the thiolation step. CDT activation was performed at 23±2°C for 1 hour. The activation level was determined by HPLC (A220 / A205)....

Embodiment 3

[1778] Example 3: Preparation of additional Pn-33F eTEC conjugate

[1779] Additional Pn-33F eTEC conjugates were produced using the method described in Example 2. The reaction parameters and characterization data of these additional batches of Pn-33F eTEC glycoconjugates are given in Table 3.

[1780] Table 3. Experimental parameters and characterization data of additional Pn33F eTEC conjugates

[1781]

[1782] LOQ = limit of quantification; N / A = not available

[1783] As described above and in Table 3, several Pn-33F conjugates were obtained using the above-mentioned eTEC conjugation. eTEC chemistry makes it possible to prepare conjugates with high yields, low% free sugars and high degree of conjugation (conjugated lysine). In addition, more than 80% of acetyl functionality can be maintained using the eTEC conjugation method.

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Abstract

The present invention relates to new immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens (glycoconjugates), kits comprising said immunogenic compositions 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 pneumoccocal infections using said novel immunogenic compositions.

Description

Invention field [0001] The present invention relates to a novel immunogenic composition comprising a capsular saccharide antigen (glycoconjugate) conjugated, a kit comprising the immunogenic composition and the use thereof. The immunogenic composition of the invention will generally comprise a glycoconjugate, wherein the sugar is derived from the serotype of Streptococcus pneumoniae. The invention also relates to the use of the new immunogenic composition and kit to vaccinate human subjects (especially infants and the elderly) against pneumococcal infection. Background of the invention [0002] Infections caused by pneumococcal bacteria are the main cause of morbidity and death worldwide. Pneumonia, febrile bacteraemia and meningitis are the most common manifestations of invasive pneumococcal disease, and the spread of bacteria in the respiratory tract can lead to middle ear infections, sinusitis or recurrent bronchitis. Compared with invasive diseases, non-invasive manifestati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/09A61K39/385A61K39/00
CPCA61K39/385A61K2039/6037A61K2039/70A61K47/6415A61K47/646C08B37/006C08H1/00A61K39/092A61P31/00A61P31/04A61P37/04A61P43/00Y02A50/30A61K2039/6068A61K2039/55A61K2039/545A61K2039/55505
Inventor W·J·沃森L·P·霍达尔 马丁-蒙塔尔沃R·E·伊斯图里斯R·R·赖纳特
Owner PFIZER INC
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