Multivalent pneumococcal conjugate vaccine

A pneumococcal and combined vaccine technology, applied in the field of medicine and biology, can solve the problems of low reliability of test results and many interference factors

Active Publication Date: 2020-10-27
BEIJING ZHIFEI LVZHU BIOPHARM +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] One of the difficulties in the development of multivalent products is the verification of the product. The higher the price, the more complex the internal components, the more interference factors during the verification, and the lower the reliability of the test results.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1: Reductive amine method prepares conjugate:

[0039] Dissolve the pneumococcal polysaccharide, hydrolyze it with acetic acid solution, adjust the pH value to 6.4, add sodium periodate for oxidation, stop the reaction with glycerol, remove small molecular substances by dialysis or ultrafiltration, and obtain oxidized polysaccharide. Add ADH and sodium borocyanide to the oxidized polysaccharide to a final concentration of 40 mg / ml and 2 mg / ml, and react at room temperature for 3 days to prepare derivatives. The derivatized polysaccharide and diphtheria toxoid are mixed according to a certain mass ratio, EDAC is added to a final concentration of 0.02mol / L, and the pH value is maintained at 5.6 for reaction for more than 150 minutes to prepare a conjugate. The conjugate was purified by Sepharose 4FF chromatography, and the elution peak near V0 was collected to obtain the stock solution of the conjugate. 1, 2, 3, 4, 5, 6A, 6B, 7F, 9V, 12F, 14, 18C and 23F were ...

Embodiment 2

[0040] Embodiment 2,: cyanation reaction prepares conjugate

[0041] Dissolve pneumococcal polysaccharide, adjust the pH value to about 9.0, add CDAP acetonitrile solution (100mg / ml concentration) according to the mass ratio of 1:0.75, maintain the pH value of 9.00-10.00 for reaction, and add 2% triethylamine solution with CDAP equal volume , the pH value is 10.00-11.00, react for 5 minutes, adjust the pH value to about 8.60, add tetanus toxoid according to the appropriate polysaccharide-protein mass ratio, maintain the pH value near 8.6 and react for more than 120 minutes, stop the reaction with glycine, and obtain it after ultrafiltration or dialysis polysaccharide conjugates. The conjugate was purified by Sepharose 4FF chromatography, and the elution peak near V0 was collected to obtain the stock solution of the conjugate. 8, 10A, 11A, 15B, 19A, 19F, 22F, 24F, 33F and 35B were prepared by cyanation.

Embodiment 3

[0042] Embodiment 3, the preparation of liquid injection

[0043] Mix 15 kinds of pneumococcal conjugate stocks (1, 2, 3, 4, 5, 6A, 6B, 7F, 9V, 12F, 14, 18C, 19A, 19F, 23F) in a certain proportion, and add an appropriate amount of aluminum phosphate adjuvant Absorbed, prepared as a semi-finished product with a content of various types of pneumococcal polysaccharides of 4 μg / ml (6B is 8 μg / ml) and an aluminum ion content of not higher than 0.4 mg / ml, divided into 0.5 ml / cartridge, ready to be obtained.

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PUM

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Abstract

The invention provides a multivalent pneumococcal conjugate vaccine. The vaccine consists of a liquid injection and lyophilized powder; the liquid injection is the conjugate that contains 15 pneumococcal serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 9V, 12F, 14, 18C, 19A, 19F and 23F and is prepared by taking diphtheria toxoid as carrier protein; and the lyophilized powder is the conjugate that contains 8pneumococcal serotypes 8, 10A, 11A, 15B, 22F, 24F, 33F and 35B and is prepared by taking tetanus toxoid as the carrier protein. Through the combined using after the lyophilized powder is dissolved inthe liquid injection, the vaccine can be used for preventing the infection caused by the pneumococcus including the serotypes.

Description

technical field [0001] The invention belongs to the field of medical biology and relates to a pneumonia vaccine, which consists of two parts, respectively containing 15 and 8 pneumococcal serotypes, which are used in combination to prevent infection caused by the included serotypes of pneumococcus. Background technique [0002] Pneumococcus (Streptococcus pneumoniae) is the main pathogenic bacteria that causes pneumonia, meningitis, bacteremia, etc. in children and the elderly, and has a high morbidity and mortality rate in the world. At present, preventive preparations (vaccine) have been used in different populations, including pneumococcal polysaccharide vaccine used in people over 2 years old and pneumococcal conjugate vaccine used in infants and young children. There is only one type of pneumococcal polysaccharide vaccine, which is a 23-valent pneumococcal polysaccharide vaccine, including pneumonia serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/116A61K39/09A61K39/385A61P31/04
CPCA61K39/092A61K39/385A61P31/04A61K2039/70A61K2039/6037A61K2039/55505A61K2039/54
Inventor 杜琳朱卫华胡月凤宗向坤胡小华胡国伟
Owner BEIJING ZHIFEI LVZHU BIOPHARM
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