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Polyvalent pneumococcal capsular polysaccharide composition, its preparation method and application

A technology of capsular polysaccharide and pneumococcus, which is applied in the fields of microbiology and immunology, can solve the problems of lack of protection of serotypes and limited protection scope, and achieves the effect of good protection effect, reduction of inoculation times and wide coverage.

Active Publication Date: 2016-01-13
SINOVAC RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there are only 7-valent pneumococcal conjugate vaccines in my country, such as Prevener Approved for marketing, passive immunization for infants aged 2 to 23 months or at-risk children aged 2 to 5 to protect children from deep infection of Streptococcus pneumoniae, such as septicemia and meningitis; it can only protect 7 The price is limited, and the scope of protection is limited, while the 23-valent pneumococcal polysaccharide vaccine (such as "Neumo method ”) can provide protection for 85% of people over the age of 55 for up to five years. Since the above-mentioned serotype combination is mainly designed for the epidemic situation in developed countries in Europe and the United States, it lacks protection for Asian-specific serotypes

Method used

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  • Polyvalent pneumococcal capsular polysaccharide composition, its preparation method and application
  • Polyvalent pneumococcal capsular polysaccharide composition, its preparation method and application
  • Polyvalent pneumococcal capsular polysaccharide composition, its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Preparation of pneumococcal capsular polysaccharide stock solution

[0033] 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 The strains of Streptococcus spneumoniae were all obtained from the China Institute for the Control of Pharmaceutical and Biological Products and the Danish Serum Institute (SSI). 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 10 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...

Embodiment 2

[0038] Example 2 Preparation of polyvalent pneumococcal capsular polysaccharide composition

[0039] The 24 kinds of pneumococcal capsular polysaccharide stocks prepared in Example 1 were mixed according to the final concentration of 50 μg / ml polysaccharide content of each serotype, and then buffer solution (water for injection, physiological saline or phosphate buffer) was added to make up to the final volume. Prepare 24-valent pneumococcal polysaccharide composition.

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

[0041] The content of various types of polysaccharides in the polyvalent pneumococcal polysaccharide composition after freeze-drying was detected by immunoturbidity method, and compared with the detection results before freeze-drying to compare the changes of antigenic su...

Embodiment 3

[0046] Example 3 Preparation of polyvalent pneumococcal polysaccharide vaccine

[0047] The multivalent pneumococcal capsular polysaccharide composition was prepared in three ways.

[0048] (1) Purified 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 pneumococcal capsular polysaccharides were diluted to 1200 μg / ml, and then mixed in equal volumes to prepare 24-valent pneumococcal capsular polysaccharide compositions, so that the content of each type of polysaccharide was 50 μg / ml.

[0049] (2) Purified 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 pneumococcal capsular polysaccharides are directly mixed according to the amount of various types of polysaccharides required for vaccine preparation, and then use injection water, normal saline or phosphate buffer to dilute to the vaccine preparation volume, so that the content of various types of poly...

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Abstract

The invention provides a multivalent pneumococcal capsular polysaccharide composition as well as a preparation method and application thereof. The multivalent pneumococcal capsular polysaccharide composition contains a serotype 6A and at least one extra serotype selected from the group consisting of 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F. The multivalent pneumococcal capsular polysaccharide composition provided by the invention can be used for inducing an organism to generate humoral immunity, can generate a relatively good protecting effect for infectious diseases caused by the 24 common serotype pneumococcuses and is wide in immunity coverage rate and better in effect as comparison with various existing pneumococcal polysaccharide vaccines and conjugate vaccines sold on the market.

Description

technical field [0001] The invention belongs to the field of microbiology and immunology, and in particular relates to a polyvalent pneumococcal capsular polysaccharide composition, a preparation method and application thereof. Background technique [0002] Streptococcus pneumoniae (Streptococcuspneumoniae), referred to as pneumococcus (pneumococcus), was first isolated from the sputum of patients by Frenchman Louis Pasteur and American G.M.Sternberg in 1881. The bacterium is Gram-positive, and the bacterium is like a spearhead, diplococci arranged in pairs or short chains, and some virulent strains form capsular polysaccharides outside the bacterium. Pneumococcus is one of the main pathogens of bacterial infectious diseases, which can cause pneumonia, meningitis, sepsis, otitis media and other diseases. 5% to 10% of healthy adults and 20% to 40% of children carry this bacteria in the nasopharynx and other respiratory tracts , virulent strains are important pathogenic bacte...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/116A61K39/385A61P31/04
Inventor 高强蔡芳王见冬孙胜军王治伟陈磊王新立阮力尹卫东
Owner SINOVAC RES & DEV
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