ABC group meningococcal combined vaccine and preparation method thereof

A meningococcal and combined vaccine technology, applied in the direction of bacteria, antibacterial drugs, pharmaceutical formulations, etc., can solve the problems of vaccine safety hazards, protein carrier toxicity reversal, etc., and achieve broad pertinence, good specificity, and good specificity Effect

Active Publication Date: 2018-03-09
CHENGDU OLYMVAX BIOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, no trace of formaldehyde or glutaraldehyde is added to the conjugate vaccine with TT or DT as the protein carrier, so there is a risk of reversal of the toxicity of the protein carrier
And tetanus toxoid is a highly allergenic substance, although the detoxified tetanus toxoid (TT) also has a high risk of allergies
These factors all constitute a safety hazard of vaccination

Method used

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  • ABC group meningococcal combined vaccine and preparation method thereof
  • ABC group meningococcal combined vaccine and preparation method thereof
  • ABC group meningococcal combined vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1AB

[0033] Embodiment 1ABC group meningococcal combined vaccine and its preparation process

[0034] This example is composed of purified component antigens from four strains of meningococcus, and the specific serogroups and antigenic components are as follows:

[0035] Group A meningococcal strains were obtained from China Medical Bacteria Collection Center (CMCC), strain number CMCC29201, and the component antigen was capsular polysaccharide (CPS).

[0036] Group C meningococcal strains were obtained from China Medical Bacteria Collection Center (CMCC), strain number CMCC29205, and the component antigen was capsular polysaccharide (CPS).

[0037] Group B meningococcal strains are from China Medical Bacteria Collection Center (CMCC), strain number CMCC29356, and the component antigen is outer membrane protein vesicle (OMV).

[0038] The group B meningococcal strain is derived from the isolated strain xrsw341215 from the blood samples of domestic group B meningococcal meningitis ...

Embodiment 2

[0054] Example 2 Comparison of Immunogenicity of Group AC Meningococcal Conjugate Vaccines from Different Manufacturers

[0055] Experimental program:

[0056] 1. Vaccines from four sources are domestic 1AC vaccine, domestic 2AC vaccine, Xiangrui biological AC vaccine and the ABC group meningococcal combined vaccine prepared in Example 1.

[0057] 2. Experimental animals: BALB / C mice, 12-14 grams / body weight.

[0058] 3. Grouping: 10 mice in each group, half female and half male, and 5 mice of the same sex were raised in each tank.

[0059] 4. Immunization method: subcutaneous injection; immunization dose: 2.5 μg polysaccharide / groups A and C.

[0060] 5. Immunization procedure: three injections in the whole process, that is, one injection each on day 0, 14, and 21.

[0061] 6. Serum separation and detection: Blood was collected two weeks after each immunization, serum was separated, antibody titer of a single mouse was determined by ELISA, geometric mean titer (GMT) of eac...

Embodiment 3

[0067] Example 3 Determination of the cross-antibody between the immune serum of xrsw341215 isolated from domestic group B meningococcal meningitis patients and dominant pathogenic group B meningococcal meningitis strains from different sources at home and abroad

[0068] 1. Domestic strains: Screened from 167 domestically collected ECM patients and carriers of group B, and identified 8 dominant strains in total (Table 2).

[0069] Table 2 Domestic isolates of group B patients

[0070]

[0071]

[0072] 2. Foreign strains: respectively from the US FDA, the Netherlands National Institute of Public Health and Environmental Protection, and China National Institute for Food and Drug Control. (table 3)

[0073] Table 3 Strains collected abroad

[0074]

[0075] 3. Preparation of immune serum of xrsw341215 strain

[0076] Animals: SPF grade N1H mice, 10 / group, 12-14 grams.

[0077] Preparation of immune stock solution: Kaikai working seed batch 1 strain, inoculated in s...

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Abstract

The invention provides a group A, group B and group C meningococcus combined vaccine which is composed of polysaccharide-protein conjugates and a group B ST-4821 genotype (xrsw341215) meningococcus outer membrane protein vesicle (OMV), wherein the polysaccharide-protein conjugates are obtained in a manner that a group A meningococcus capsular polysaccharide and a group C meningococcus capsular polysaccharide are each subjected to covalent binding with a group B serotype 4-type (CMCC29356) meningococcus outer membrane protein vesicle (OMV). The vaccine can simultaneously prevent group A, group B and group C meningococcus invasive diseases, has better protective effects especially on prevention aiming at epidemic cerebrospinal meningitis high-risk groups at the age of less than 2 years, and moreover, has better specificity and better protection effect aiming at nature group A, group B and group C meningococcus invasion.

Description

technical field [0001] The invention relates to a multivalent combined vaccine composed of multiple serogroup meningococcal vaccines and its preparation process, in particular to a combined vaccine composed of ABC group meningococcal polysaccharide conjugates and protein antigen components and its preparation method. Background technique [0002] Invasive sepsis, meningitis, pneumonia and other diseases caused by meningococcal infection occur all over the world, causing high mortality and disability, and seriously threatening human health. According to the differences in the composition of meningococcal capsular polysaccharides, it can be divided into 13 serogroups, and all serogroups are pathogenic. Among them, group A, B and C cases are the most, accounting for more than 90% of meningococcal cases. [0003] At present, a variety of meningococcal vaccines of different types and combinations have been marketed at home and abroad, among which capsular polysaccharide vaccine...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/116A61P31/04C12N1/20A61K39/095
Inventor 王建华
Owner CHENGDU OLYMVAX BIOPHARM
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