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Epidemic meningitis polyose-protein binding vaccine

An epidemic meningitis, capsular polysaccharide technology, applied in the direction of peptide/protein components, organic active components, bacterial antigen components, etc., can solve the problems of poor polysaccharide antigen reactivity, short-term immune response, low-affinity antibodies, etc., to improve the immune system. Coverage, Enhanced Immunogenicity, Pain Relief Effects

Inactive Publication Date: 2003-03-12
BEIJING LUZHU BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Bacterial polysaccharides are thymus-independent antigens, which have the following characteristics: (1) only weak immune responses can be produced in young animals or infants, or even no immune responses, and the immune responses increase with age; (2) produce Antibodies with low affinity, mainly IgM and IgG antibodies; (3) only produce transient immune responses, and do not have immune memory and immune enhancement effects during repeated vaccination; (4) are prone to immune tolerance; (5) common adjuvant The agent is not easy to play an immune enhancing effect on this antigen
[0008] The thymus of infants under 2 years old is immature, and their reactivity to polysaccharide antigens is poor. After polysaccharides enter the body, they cannot be recognized by the body's immune system and cannot produce effective antibodies. Therefore, polysaccharide vaccines for children under 2 years old cannot produce protective antibody
However, if the polysaccharide conjugate vaccine is inoculated first, and then the tetanus toxoid is inoculated, only the enhancement of the tetanus toxoid antibody response can be seen, but there is no enhancement effect on the immunogenicity of the polysaccharide antigen of the vaccine

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1 A+C group meningococcal polysaccharide-tetanus toxoid conjugate vaccine (1) purification of meningococcal polysaccharide

[0028] Proper medium can be selected for the production of polysaccharide vaccines. The liquid medium used for production should not contain components that can form precipitates with the added cetyltrimethylammonium bromide. The culture medium should not contain harmful or other allergen substances to the human body.

[0029]After inoculating the strains in a suitable medium, harvest after the logarithmic production phase or early in the stationary phase. It is advisable to add formaldehyde solution to the culture to sterilize or heat to sterilize, so as to ensure the safety of sterilization and not damage the polysaccharide of the bacteria. Centrifuge the sterilized single harvest (or combined harvest) to remove bacteria, collect the supernatant, add hexadecyltrimethylammonium bromide to it, mix well, and collect the precipitate by ...

Embodiment 2

[0041] Example 2 Group A Meningococcal Meningitis Polysaccharide-TT Conjugate Vaccine (1) Aluminum Hydroxide Adsorption Group A Meningococcal Meningitis Polysaccharide-TT Conjugate Vaccine

[0042] Dilute the group A meningococcal polysaccharide-TT conjugate vaccine stock solution to 100 μg / ml (calculated as polysaccharide), take 10ml in a 100ml Erlenmeyer flask, add 40ml aluminum hydroxide adjuvant (concentration is 1.25mg / ml, calculated as aluminum ion Calculation), mix thoroughly and place at 4-8°C. Packed according to the amount containing 10 μg / 0.5ml of group A meningococcal meningitis polysaccharide, that is, aluminum hydroxide adsorbed group A meningitis meningitis polysaccharide-TT conjugate vaccine.

[0043] Animal test: Prepare aluminum hydroxide-adsorbed group A meningococcal polysaccharide-TT conjugate vaccine according to the above method, and each milliliter of vaccine contains 20 μg of group A meningococcal polysaccharide. After diluting with 3 times the volume...

Embodiment 3

[0049] Example 3 Group C Meningococcal Polysaccharide-TT Conjugate Vaccine (1) Aluminum Hydroxide Adsorption of Group C Meningococcal Polysaccharide-TT Conjugate Vaccine

[0050] Dilute the stock solution of group C meningococcal meningitis polysaccharide-TT conjugate vaccine to 100 μg / ml (calculated as polysaccharide), take 10ml, add 40ml of aluminum hydroxide adjuvant (concentration is 1.25mg / ml, calculated as aluminum ion), and mix well Store at 4-8°C. Packed according to the amount containing 10 μg / 0.5ml of group C meningococcal polysaccharide, it is aluminum hydroxide adsorption group C meningococcal polysaccharide-TT conjugate vaccine.

[0051] Animal test: Prepare aluminum hydroxide-adsorbed group C meningococcal polysaccharide-TT conjugate vaccine according to the above method, and each milliliter of vaccine contains 20 μg of group C meningococcal polysaccharide. After diluting with 3 times the volume of aluminum diluent, it is a vaccine for animal experiments contain...

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PUM

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Abstract

A polyose-protein vaccine for epidemic cerebrospinal meningitis is prepared through chemically binding the two Neisseria capsular polyoses of cluster-A and-C epidemic cerebrospinal meningitis with protein carrier by covalent bonds.

Description

Technical field: [0001] The invention relates to a vaccine preparation, in particular to an epidemic cerebrospinal meningitis capsular polysaccharide-protein combination vaccine. Background technique: [0002] Meningococcal meningitis is an infectious disease with a long history. It is endemic in a very wide area and covers all continents of the world. It has not been effectively controlled so far. [0003] Neisseria meningitidis is the pathogenic bacterium that causes epidemic meningitis (hereinafter referred to as meningitis). According to the specificity of its capsular polysaccharide, Neisseria meningitidis can be divided into A, B, C, D, 29E, H, I, K, L, W 135 , X, Y and Z 13 serogroups, bacteria of all serogroups can cause disease, but A, B, C, Y and W 135 The virulence is the strongest, and the above-mentioned 5 serogroups account for more than 95% of the cases, among which group A and group C are the most contagious, and are the most common strains causing meningoc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/715A61K38/16A61K39/02A61P31/04
CPCY02A50/30
Inventor 孔健蒋先敏
Owner BEIJING LUZHU BIOTECH
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