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Prescription and preparation method of multi-valent pneumococcal conjugate combined vaccine

A pneumococcal and combination vaccine technology, which is applied in the field of multivalent pneumococcal conjugate combination vaccines, can solve problems such as induction of unfavorable carrier antibodies

Inactive Publication Date: 2018-07-06
BEIJING ZHIFEI LVZHU BIOPHARM +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

T cell immunity to the carrier protein is important in the polysaccharide immune response, but B cell immunity to the carrier protein may be detrimental to the induction of carrier antibodies [Barington T, et al, 1994] [Barington T, et al, 1993]

Method used

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  • Prescription and preparation method of multi-valent pneumococcal conjugate combined vaccine
  • Prescription and preparation method of multi-valent pneumococcal conjugate combined vaccine
  • Prescription and preparation method of multi-valent pneumococcal conjugate combined vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1: Combination formulation of multivalent pneumococcal conjugates

[0046] Each 0.5ml dose contains a total of 22 μg of various types of pneumococcal polysaccharides (total polysaccharides), of which 2 μg each of 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20, 22F and 33F. Various types of polysaccharides are combined with diphtheria toxoid and adsorbed on aluminum phosphate adjuvant (aluminum content 0.125 mg), and the solvent is physiological sodium chloride solution.

Embodiment 2

[0047] Embodiment 2: Purified pneumococcal polysaccharide assay result

[0048] The 11 types of pneumococcal capsular polysaccharides were purified separately, with 3 batches for each type, and the quality inspection results of each batch are shown in Table 2:

[0049]

Embodiment 3

[0050] Embodiment 3: Pneumococcal conjugate assay result

[0051] 11 types of pneumococcal conjugates prepared by the amine reduction method, various types of pneumococcal polysaccharides combined with diphtheria toxoid, 3 batches for each type, the test results of each batch of conjugates are shown in Table 3:

[0052]

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PUM

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Abstract

The invention relates to a prescription and a preparation method of a multi-valent pneumococcal conjugate combined vaccine. The combined vaccine is prepared by pneumococcal capsular polysaccharides selecting from pneumococcal serotypes 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20, 22F and 33F and biologically-acceptable carrier proteins. The prescription and the preparation method provided by the invention have the benefits that a polysaccharide protein conjugate stock solution is prepared by selecting a binding method suitable for the different types of pneumococcal polysaccharides, and the different types of pneumococcal polysaccharides are combined to prepare the vaccine. The combined vaccine is used for preventing infectious diseases caused by unlisted pneumococcal polysaccharide protein-binding vaccine serotype pneumococci.

Description

technical field [0001] The invention relates to a prescription of a multivalent pneumococcus conjugate combined vaccine and a preparation method thereof. The stock solution of the conjugate is prepared by selecting a conjugation method suitable for different types of polysaccharides, and combining them to prepare a vaccine. The combined vaccine is used to prevent infectious diseases caused by serotype pneumococcus of non-listed pneumococcal polysaccharide conjugate vaccine. The combination vaccine is prepared from pneumococcal capsular polysaccharide selected from serotypes 2, 8, 9N, 10A, 11A, 12F, 15B, 17F, 20, 22F and 33F and physiologically acceptable carrier protein. Background technique [0002] Pneumococcus is the most important pathogen of meningitis, bacteremia, pneumonia and otitis media, and can cause systemic infection. Resistance of pneumococci to penicillin and other commonly used antimicrobials complicates treatment options and leads to treatment failure. Im...

Claims

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Application Information

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IPC IPC(8): A61K39/116A61K39/09A61K39/385A61P31/04
CPCA61K39/092A61K39/385A61K2039/6031A61K2039/6037A61K2039/6068A61K2039/70
Inventor 胡月凤朱卫华杜琳
Owner BEIJING ZHIFEI LVZHU BIOPHARM
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