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Combined vaccine bonding bacterial polysaccharides and protein for human

A combined vaccine and bacterial polysaccharide technology, applied in the direction of antibacterial drugs, bacterial antigen components, medical preparations containing active ingredients, etc.

Inactive Publication Date: 2009-10-21
BEIJING ZHIFEI LVZHU BIOPHARM +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, there are exotoxin A, P6 and some high-molecular outer membrane proteins of Pseudomonas aeruginosa, as well as unrelated proteins such as human serum albumin, etc., but these protein carriers are still in the stage of animal experiments and have not been used clinically.

Method used

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  • Combined vaccine bonding bacterial polysaccharides and protein for human
  • Combined vaccine bonding bacterial polysaccharides and protein for human
  • Combined vaccine bonding bacterial polysaccharides and protein for human

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Preparation of Capsular Polysaccharides of Group A and C Meningococci and Capsular Polysaccharide of Haemophilus Influenzae Type B Conjugate Vaccine

[0021] Prepare group A meningococcal capsular polysaccharide-TT conjugate vaccine stock solution, group C meningococcal capsular polysaccharide-TT conjugate vaccine stock solution, b Haemophilus influenzae type capsular polysaccharide-TT conjugate vaccine stock solution. Dilute group A meningococcal capsular polysaccharide-TT conjugate vaccine stock solution, group C meningococcal capsular polysaccharide-TT conjugate vaccine stock solution, and Haemophilus influenzae type b capsular polysaccharide-TT conjugate vaccine stock solution to 60-120 μg respectively / ml (according to polysaccharide calculation), add the above three diluted vaccine solutions into a sterile container according to the required amount, after mixing thoroughly, add a certain amount of sterile pyrogen-free sodium chloride and aluminum hydroxide Adjuva...

Embodiment 2

[0023] HibACon TM Clinical Research Trials in Children 1-2 Years

[0024] 3 batches of Group AC meningococcus-Haemophilus influenzae type b capsular polysaccharide conjugate vaccine prepared in the GMP workshop according to the above-mentioned Example 1 method according to GMP requirements, each milliliter of the vaccine contains Group A and Group C meningococcal capsular polysaccharides 20 μg each of Haemophilus influenzae type b capsular polysaccharide. The State Food and Drug Administration has randomly inspected a batch of vaccines for clinical trials.

[0025]The clinical research was carried out by double-blind method, and the vaccinated people who met the age group of enrollment were all never vaccinated with group A or group A+C meningococcal polysaccharide vaccine and Haemophilus influenzae type b conjugate vaccine.

[0026] The clinical study was divided into 4 research groups (two different immunization program groups, each program group was inoculated with differ...

Embodiment 3

[0038] HibACon TM Clinical research trials in infants 3-8 months of age

[0039] 3 batches of AC group meningococcus-type b Haemophilus influenzae capsular polysaccharide conjugate vaccine prepared according to the method of above-mentioned embodiment 1, each dose of HibACon vaccine contains A group, C group meningococcal capsular polysaccharide, b type haemophilus Each 10 μg of Bacillus influenzae capsular polysaccharide.

[0040] The clinical research is carried out by double-blind method. All the vaccinated people in the age group who met the enrollment had never been vaccinated with group A or group A+C meningococcal polysaccharide vaccine and Haemophilus influenzae type b conjugate vaccine. The clinical study was divided into two research groups, each group was inoculated with different doses (15 μg, 30 μg) of the research vaccine, and the control group was the Haemophilus influenzae type b conjugate vaccine. Infants aged 3-8 months were inoculated 3 injections, with a...

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PUM

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Abstract

The invention discloses a bacterial polysaccharides and protein binding combined vaccine for human, wherein Group A and Group B epidemic cerebrospinal meningitis Neisser's coccus capsular polysaccharides and Type B haemophilus influenzae capsular polysaccharide are bonded on an effective protein carrier with covalent bonds by a chemical method to prepare a preventive combined vaccine bonding polysaccharides and protein for human. Three vaccinations are conducted on children with the age of three to eight months and each for one month, and one vaccination is conducted on children older than one year. More than 96.5 percent of vaccine inoculators can be immunized from the Group A and Group C epidemic cerebrospinal meningitis Neisser's coccus and 91.2 percent of the vaccine inoculators can obtain long-term immunity from the Type B haemophilus influenzae one month after immunization. The vaccine is applied to the prevention of the infection caused by the Group A and Group C epidemic cerebrospinal meningitis Neisser's coccus and the Type B haemophilus influenzae.

Description

Technical field: [0001] The invention relates to a combined vaccine preparation of a covalent conjugate of trivalent bacterial capsular polysaccharide and protein for humans, which contains the capsular polysaccharide-protein conjugate of epidemic cerebrospinal meningococcus of group A and group C and type B hemophilic influenza Combination vaccines of capsular polysaccharide-protein conjugates of Bacillus infectiensis. The technical invention related to it is disclosed in the Chinese patent ZL 02159032.X, and the present invention particularly relates to that the preparation can be used to prevent meningococcus A, C group meningococcus and Haemophilus influenzae bacillus type B in children over 3 months old Infect. Background technique: [0002] Meningococcal meningitis is a human infectious disease with a long history. It is endemic in a very wide area and spreads all over the world. It has not been effectively controlled so far. The causative agent of the disease, Neiss...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/095A61K39/102A61K39/116A61P31/04
Inventor 孔健蒋先敏蒋仁生
Owner BEIJING ZHIFEI LVZHU BIOPHARM
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