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High-efficiency 14-valent pneumococcal conjugate vaccine

A pneumococcal and combined vaccine technology, applied in the field of immunology, can solve the problems of low-affinity antibodies, lack of immune memory and immune enhancement effects, and prone to immune tolerance

Inactive Publication Date: 2009-12-02
广州精达医学科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, polysaccharide vaccines have the following problems: (1) in young animals or infants, only a weak immune response can be produced, or even no immune response, and the immune response increases with age; (2) produce low-affinity antibodies, mainly It is IgM; (3) It only produces a short-term immune response, and does not have the immune memory and immune enhancement effect during repeated vaccination; (4) It is easy to produce immune tolerance; (5) Common adjuvants are not easy to be immune to this antigen enhanced effect
[0013] However, the data in my country show that the serotypes of pneumococcal infection strains are: 5, 6, 1, 19, 23, 14, 2, 4, and the coverage rate of Wyeth 7-valent pneumococcal conjugate vaccine to common pathogenic bacteria in my country is only 33.9%.
Wyeth 7-valent pneumococcal conjugate vaccine requires 4 injections, 860 yuan per injection, which is expensive and not conducive to promotion

Method used

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  • High-efficiency 14-valent pneumococcal conjugate vaccine
  • High-efficiency 14-valent pneumococcal conjugate vaccine
  • High-efficiency 14-valent pneumococcal conjugate vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: the cultivation of 14 kinds of serotypes of pneumococcus

[0038] Considering factors such as the prevailing bacterial type in China, the susceptible bacterial type of children and the elderly, the drug-resistant bacterial type, and cross-protection, 14 serotypes (1, 2, 4, 5, 6A, 6B, 7F, 9N, 9V, 14, 18C, 19A, 19F and 23F) pneumococcal culture;

[0039] (1) Bacteria: 1, 2, 4, 5, 6A, 6B, 7F, 9N, 9V, 14, 18C, 19A, 19F, and 23F, a total of 14 serotype strains, which can be purchased from China Pharmaceutical and Biological Products Inspection Institute (China Medical Bacteria Preservation Management Center), the deposit numbers are 31401, 31402, 31404, 31405, 31406, 31409, 31414, 31419, 31423, 31426, 31451, 31456, 31457 and 31468. It can be identified by fluorescent labeling first, first incubated with serotype-specific primary antibody from rabbit, and then incubated with Rhodamine Red-X-labeled goat anti-rabbit IgG (secondary antibody), and the normal resul...

Embodiment 2

[0043] Example 2: Purification of pneumococcal capsular polysaccharide and its quality identification

[0044] 1. Purification of pneumococcal capsular polysaccharide:

[0045] (1) The sterilized bacterial liquid is centrifuged with a centrifuge to remove the bacterial cells to obtain a stock solution-crude polysaccharide, and the bacterial cells separated by centrifugation are sterilized with formaldehyde. (2) After obtaining the crude solution of polysaccharide aggregated from the stock solution, cetyltrimethylammonium bromide is added to precipitate the composite polysaccharide, and the polysaccharide is precipitated and centrifuged to aggregate the polysaccharide. (3) After the precipitation and centrifugation are completed to collect the complex polysaccharide, dissociation and purification of calcium chloride is carried out. Subsequently, 95% alcohol was added for nucleic acid removal. Afterwards, continue to add alcohol with a concentration of 95% to precipitate polys...

Embodiment 3

[0050] Embodiment 3: Carrier protein (influenza hemotropic protein D, tetanus toxoid protein and diphtheria toxin avirulent variant protein CRM 197 ) quality control

[0051] Using the safe and effective influenza hemotropic D protein, tetanus toxoid protein and diphtheria toxin non-toxic variant protein CRM that has been verified by clinical experiments 197 As the protein carrier of our conjugated vaccine, its characteristics and purity were checked by referring to the existing internationally recognized quality standards: Determination of CRM of influenza hemotropic protein D, tetanus toxoid protein and diphtheria toxin non-toxic variant protein by HPLC 197 The purity is more than 90% qualified; ensure that the amino acid sequence of each protein is correct; ensure that it is not produced in the same workshop as diphtheria toxoid; use SDS-PAGE analysis to determine the composition of the purified protein; the content of lipopolysaccharide is less than 8 % means that the qua...

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Abstract

The invention relates to a high-efficiency 14-valent pneumococcal conjugate vaccine, which is formed by coupling and combining capsular polysaccharide extracted from fourteen types of serotype pneumococcuses and carrier protein; the fourteen types of the serotype pneumococcuses are 1, 2, 4, 5, 6A, 6B, 7F, 9N, 9V, 14, 18C, 19A, 19F and 23F; and the carrier protein is diphtherin non-toxic mutated protein CRM197, tetanus toxin protein and influenza haemophilus protein D. Compared with the prior pneumococcal conjugate vaccine, the high-efficiency 14-valent pneumococcal conjugate vaccine has the advantages that: (1) the cross-protection rate of the pneumococcuses of fourteen serotypes (1, 2, 4, 5, 6A, 6B, 7F, 9N, 9V, 14, 18C, 19A, 19F and 23F) reaches more than 90 percent; and (2) the high-efficiency 14-valent pneumococcal conjugate vaccine can generate effective protection on senior citizens which are susceptible to pneumonia and is suitable for children under two years old.

Description

Technical field: [0001] The invention relates to the field of immunology, in particular to a high-efficiency 14-valent pneumococcal conjugate vaccine for preventing pneumococcal infection. Background technique: [0002] Pneumococcus (S.pneumoniae), such as figure 1 As shown, the threat to the world is increasing day by day. The likelihood of pneumococcal disease flares during influenza is further increased by the spread of antibiotic-resistant infectious diseases and the fact that pneumococcal pneumonia often follows influenza infection. Diseases caused by Streptococcus pneumoniae have become an important public health problem worldwide. Pneumococcus has become the number one killer of children in the world, the specific statistics are as follows figure 2 shown. [0003] According to the statistics of the World Health Organization in 2005, an average of 1.6 million people die from this disease every year, including 700,000 to 1,000,000 children under the age of 5. In 2...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/09A61K47/42A61P31/04A61P11/00A61K39/385
Inventor 胡勇
Owner 广州精达医学科技有限公司
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