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Multivalence pneumococcus capsular polysaccharide-protein conjugate composition and preparation method thereof

A protein conjugate and capsular polysaccharide technology, applied in the field of multivalent pneumococcal capsular polysaccharide-protein conjugate composition and its preparation, can solve the problems of limited protection range and lack of protection of serotypes, and reduce vaccination The number of stitches, the convenience of industrialized mass production, and the effect of covering a wide range

Active Publication Date: 2014-03-26
SINOVAC RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there is only 7-valent pneumococcal conjugate vaccine in my country Approved for marketing, it can only protect 7 valences, and the scope of protection is limited, unlike other 10-valent pneumococcal conjugate vaccines 13-valent pneumococcal conjugate vaccine Its serotype combination is mainly designed for the epidemic situation in developed countries in Europe and the United States, and it lacks protection against the unique serotypes in my country

Method used

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  • Multivalence pneumococcus capsular polysaccharide-protein conjugate composition and preparation method thereof
  • Multivalence pneumococcus capsular polysaccharide-protein conjugate composition and preparation method thereof
  • Multivalence pneumococcus capsular polysaccharide-protein conjugate composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1 Preparation of pneumococcal capsular polysaccharide stock solution

[0030] 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F serotype pneumonia All strains of Streptococcus pneumoniae were obtained from the China Institute for the Control of Pharmaceutical and Biological Products. The above strains were subcultured to establish the original seed bank, main seed bank and working seed bank. The generations were as follows: the original seed batch was the first generation, the main seed batch was the fourth generation, and the working seed batch was the eighth generation. From the opening of the working seed batch to the cultivation in the inoculated fermenter, the passage should not exceed 5 generations. The seeds of each generation use milk powder as a freeze-drying protective agent and freeze-dried for preservation. Take the working seeds and pick the strains by streaking on the soybean peptone solid med...

Embodiment 2

[0035] Example 2 Preparation of polyvalent pneumococcal capsular polysaccharide-protein conjugate composition

[0036] The 24 kinds of pneumococcal capsular polysaccharide stock solutions prepared in Example 1 were acidified and degraded with hydrochloric acid, and then sodium periodate was added to the polysaccharide for oxidation. After oxidation, the activation degree of the polysaccharide was detected, and then polysaccharide: protein = 0.4-3 Add the purified diphtheria toxoid CRM197 protein at a mass ratio of :1 for binding, and then add sodium borohydride to terminate the binding reaction to prepare pneumococcal capsular polysaccharide conjugates. The conjugates are dialyzed by ultrafiltration to remove unbound proteins and polysaccharide, after purification, use a 0.22 μm filter to sterilize and filter, which is the monovalent conjugate of pneumococcal capsular polysaccharide-protein.

[0037] 1, 2, 3, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F,...

Embodiment 3

[0038] Example 3 Preparation of multivalent pneumococcal capsular polysaccharide conjugate vaccine

[0039] 1, 2, 3, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and The pneumococcal capsular polysaccharide-protein monovalent conjugate of 33F serotype is mixed according to the final polysaccharide concentration of 4 μg / ml, and the 6B conjugate is mixed according to the final polysaccharide concentration of 8 μg / ml, and aluminum phosphate adjuvant is added to make 24-valent pneumococcal capsule Polysaccharide conjugate vaccine with an aluminum content of 0.4 mg / ml.

[0040] The 24-valent pneumococcal capsular polysaccharide conjugate vaccine prepared above was made into a freeze-dried dosage form by low-temperature drying, and reconstituted with physiological saline before use.

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Abstract

The invention provides a multivalence pneumococcus capsular polysaccharide-protein conjugate composition and a preparation method thereof. The conjugate composition is prepared from capsular polysaccharides of pneumococcus of 24 different serotypes and a carrier protein in a covalence connection manner, wherein the 24 different serotypes are 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F. The conjugate composition is good in adsorption effect and stability, has multiple immunogenicity and protection properties aiming at invasion of pneumococcus of the 24 serotypes, and is superior to the low-valence pneumonia composition in the market, and the immune response is higher than that of uncombined compositions. By inoculating a multivalence pneumococcus capsular polysaccharide conjugate vaccine prepared from the conjugate composition, the inoculation injection times can be reduced, the immunization procedure can be simplified, and meanwhile human beings and animals can be effectively prevented from diseases resulted from the pneumococcus of the 24 serotypes, and the conjugate composition is wide in coverage range and good in immune effect.

Description

technical field [0001] The invention belongs to the field of microbiology and immunology, and in particular relates to a polyvalent pneumococcal capsular polysaccharide-protein conjugate composition and a preparation method thereof. Background technique [0002] Streptococcus pneumoniae can cause invasive diseases such as meningitis and pneumonia and non-invasive diseases such as otitis media. According to United Nations statistics, more than one million children under the age of two die each year from diseases caused by pneumococcus. At present, the main defenses against Streptococcus pneumoniae are polysaccharide vaccines and conjugate vaccines. The protective effect of the former in adults has been confirmed, but for the main susceptible population of Streptococcus pneumoniae, the protection in infants and young children is very weak . Because of its ability to induce effective protection and immune memory in infants and young children, conjugate vaccines have been incl...

Claims

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Application Information

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IPC IPC(8): A61K39/116A61K39/09A61K47/48A61P31/04A61K47/64
Inventor 高强王新立孙胜军蔡芳王见冬王治伟阮力尹卫东
Owner SINOVAC RES & DEV
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