Bacterial polysaccharide protein conjugate vaccine using hepatitis B surface antigen as carrier protein and preparation method of bacterial polysaccharide protein conjugate vaccine

A technology of hepatitis B surface antigen and bacterial polysaccharide, which is applied in the field of human vaccines

Inactive Publication Date: 2015-03-04
云南沃森生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the bacterial polysaccharide protein-conjugated vaccines currently on the market at home and abroad are only used to prevent diseases caused by bacterial polys

Method used

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  • Bacterial polysaccharide protein conjugate vaccine using hepatitis B surface antigen as carrier protein and preparation method of bacterial polysaccharide protein conjugate vaccine
  • Bacterial polysaccharide protein conjugate vaccine using hepatitis B surface antigen as carrier protein and preparation method of bacterial polysaccharide protein conjugate vaccine
  • Bacterial polysaccharide protein conjugate vaccine using hepatitis B surface antigen as carrier protein and preparation method of bacterial polysaccharide protein conjugate vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 7：- 2 preparation 。 Embodiment 8(1)～(13):- preparation ； Embodiment 9(1)～(13)： preparation 。 Embodiment 10： test 。 Embodiment 11(1)～(4)： test 。 Embodiment 12

[0054] Embodiment 1~embodiment 5 is the preparation of bacterial polysaccharide. Example 6: Preparation of hepatitis B surface antigen. Example 7: Preparation of bacterial polysaccharide-adipic hydrazide derivatives. Embodiment 8 (1)-(13): Preparation of bacterial polysaccharide-hepatitis B surface antigen conjugate stock solution; Embodiment 9 (1)-(13): Preparation of vaccine product. Example 10: Effectiveness test of vaccine products. Example 11(1)-(4): Safety test of vaccine products. Embodiment 12: Statistical analysis of test results.

Embodiment 1

[0055] Example 1 Preparation of Group B streptococcus and Streptococcus pneumoniae polysaccharide

[0056] (1) Fermentation: Use Type Ia Group B Streptococcus, Type Ib Group B Streptococcus, Type II Group B Streptococcus, Type III Group B Streptococcus, Type V Group B Streptococcus, Type 1 Pneumococcus, Type 2 Pneumococcus Pneumococcus type 3, pneumococcus type 4, pneumococcus type 5, pneumococcus type 6A, pneumococcus type 6B, pneumococcus type 7F, pneumococcus type 8, pneumococcus type 9N, pneumococcus type 9V, pneumococcus type 10A Pneumococcus type 11A, pneumococcus type 14, pneumococcus type 15B, pneumococcus type 17F, pneumococcus type 18C, pneumococcus type 19A, pneumococcus type 19F, pneumococcus type 20, pneumococcus type 22F, pneumococcus type 23F The working seeds of coccus or 33F pneumococcus were respectively inoculated in the improved semi-comprehensive medium, and cultured in a carbon dioxide environment at 35-37°C for 4-12 hours, when the culture medium OD 600...

Embodiment 2

[0061] Example 2: Preparation of meningococcal polysaccharide

[0062] The working seeds of Neisserial meningococcus of group A, group C, group Y or group W135 were respectively used to prepare corresponding meningococcal polysaccharides according to the following methods:

[0063] Inoculate the working seeds of group A or group C or group Y or W135 Neisserial meningococcus on the agar medium containing 10% (volume fraction) sheep blood, and cultivate in a carbon dioxide environment at 35-37°C for 16-20 hours , the Gram staining microscope was qualified, inoculated in a fermenter, and sterilized with formaldehyde solution when cultured in a meningococcal modified semi-comprehensive medium to the late logarithmic growth phase. Add cetyltrimethylammonium bromide to the supernatant collected by centrifugation, and mix the precipitate thoroughly; collect the precipitate by centrifugation, add calcium chloride to dissociate, collect the supernatant by centrifugation, add ethanol un...

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Abstract

The invention discloses a bacterial polysaccharide protein conjugate vaccine using a hepatitis B surface antigen as carrier protein and a preparation method of the bacterial polysaccharide protein conjugate vaccine. According to the vaccine, protein is the hepatitis B surface antigen, and a bacterial polysaccharide is selected from any one or more of a haemophilus influenza type b polysaccharide, group A, group C, group Y and group W135 meningococcal polysaccharides, a salmonella typhi type Vi polysaccharide, a group B streptococcus type Ia polysaccharide and the like, pneumococcus serotype type 1, 2 and the like, and salmonella paratyphi type A or salmonella paratyphi type B. Animal experiments show that the antibody positive conversion rates of the bacterial polysaccharide and the hepatitis B surface antigen in the vaccine are both more than 85%, so that the vaccine is relatively high in antibody positive conversion rate; carrier protein plays a role in transforming the bacterial polysaccharide from a T-cell-independent antigen into a T-cell-dependent antigen, and also can be used for preventing diseases caused by hepatitis B virus; and by adopting the bacterial polysaccharide protein conjugate vaccine disclosed by the invention, the problem of performing immunization inoculation on infants and young children under 2 years old can be solved, the function of one injection with multiple immune effects also can be achieved, and the use crowd and coverage rate of the vaccine can be expanded.

Description

technical field [0001] The invention relates to the technical field of human vaccines, in particular to a monovalent or multivalent vaccine product made from a bacterial polysaccharide protein conjugate prepared with hepatitis B surface antigen as a carrier protein and a preparation method thereof. Background technique [0002] Bacterial polysaccharide is one of the main virulence factors of bacteria, which has good immunogenicity and can induce the body to produce effective protective antibodies. However, bacterial polysaccharides are non-T cell-dependent antigens, and cannot induce effective protective antibodies and cannot produce immune memory for infants under the age of 2 with immature immune systems. After the bacterial polysaccharide antigen is covalently combined with the carrier protein, the bacterial polysaccharide can be converted from a T-cell-independent antigen to a T-cell-dependent antigen, so that the bacterial polysaccharide can also produce effective antib...

Claims

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Application Information

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IPC IPC(8): A61K39/385A61K39/295A61K47/48A61P31/04A61P31/20A61K39/29
CPCY02A50/30
Inventor 马波陈玉秋吴凯黄镇何建东范荣坤陶佳明白锐琼钱雯
Owner 云南沃森生物技术股份有限公司
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