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Multivalent group B meningococcal protein vaccine and preparation method thereof

A meningococcal and protein vaccine technology, applied in the preparation methods of peptides, chemical instruments and methods, bacteria, etc., can solve the complexity of the vaccine preparation process, the excessive purification, the difficulty of 4CMenB vaccine to achieve wide coverage, the change of three-dimensional natural conformation, etc. problems, to achieve good protection and immunity persistence, to ensure vaccine protection coverage, and to maintain the effect of three-dimensional natural conformation

Active Publication Date: 2014-11-05
BEIJING SANROAD BIOLOGICAL PROD CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0025] 2. Limitations of the protective coverage of OMV vaccines
[0028] 3. The production process of MenB OMV affects its antigenicity
[0033] ① Group B has more Nm types and subtypes, and the cross protection between them is weak;
[0035] ③ The complexity and over-purification of foreign vaccine preparation processes have changed the three-dimensional natural conformation of bacterial antigens (protein II, III, and IV spatial conformations), and the induced antibodies lack specificity against the invasion of natural epidemic strains;
[0036] ④Excessive purification process also leads to the loss, damage, and singleness of abundant antigenic sites, which affects its antigenicity
[0041] The fHbp in the 4C MenB vaccine is Variant 1, and the effectiveness of immune serum against fHbp Variant 1 strains can reach 95%, but the protection against Variant 2 or 3 strains is only 56%
[0043] Based on the analysis of the above factors, the 4C MenB vaccine is difficult to achieve the expected wide coverage, and it is not suitable for the prevention of group B meningococcal disease in my country

Method used

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  • Multivalent group B meningococcal protein vaccine and preparation method thereof
  • Multivalent group B meningococcal protein vaccine and preparation method thereof
  • Multivalent group B meningococcal protein vaccine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Example 1 Preparation method of multivalent group B meningococcal protein vaccine

[0074] The serotypes, subtypes, and origins of the four serogroup B meningococcal strains are as follows:

[0075] CMCC29356 strain, serotype 4, subtype: P1.19,15 (B4,P1.19,15), from the China Medical Bacteria Collection Center (CMCC); provided by the Netherlands National Institute of Public Health and Environmental Protection.

[0076] CMCC29361 strain, serotype 15, subtype: P1.7, 16 (B15, P1.7, 16), from the China Medical Bacteria Collection Center (CMCC); provided by the Netherlands National Institute of Public Health and Environmental Protection.

[0077] xrsw341215 strain, serotype 3, subtype: P1.7-2, 14, ST-4821 (B3, P1.7-24, ST-4821), isolated from a blood sample of a domestic group B epidemic cerebrospinal meningitis patient , deposit number CGMCC No.8982.

[0078] Strain xrsw210902, serotype 3, subtype: P1.22, 26, ST-8919 (B3, P1.22, 26, ST-8919), isolated from domestic cerebr...

Embodiment 2

[0131] Example 2 Determination of the cross-antibody titer of group B meningococcal vaccine strains to dominant pathogenic strains at home and abroad

[0132] 1. Source of the strain

[0133] 1.1 Domestic group B strains: Screened from 167 domestically collected group B meningococcal meningitis patients and carriers, and the identified patients isolated dominant pathogenic strains, a total of 8 strains (Table 1).

[0134] Table 1 Predominant pathogenic strains of domestic group B meningitis patients

[0135]

[0136]

[0137] 1.2 Group B strains from foreign countries come from the US FDA, the Netherlands National Institute of Public Health and Environmental Protection, and the China National Institutes for Food and Drug Control, with a total of 7 strains (Table 2).

[0138] Table 2 Foreign strains and dominant pathogenic strains of Group B vaccines

[0139]

[0140] 1. Group 3A meningococcal strains (Table 3).

[0141] Table 3 Three strains of group A meningococca...

Embodiment 3

[0167] Example 3 Acute Toxicity and Abnormal Toxicity Tests

[0168] This test utilizes the acute toxicity reaction of medicine of different doses, injects the test animal (mice, guinea pig) body of certain dose of need test solution (multivalent B group meningococcal protein vaccine prepared in embodiment 1), in the stipulated Observe the toxic reaction symptoms and death of animals within a certain period of time, and judge whether the test product meets the specified quality requirements and its safety degree.

[0169] 1. Experimental method:

[0170] 1.1 Experimental animals

[0171] Mice: NIH mice, body weight: 18-22 g / mouse, 5 in each group;

[0172] Guinea pigs: body weight: 250-350 g / guinea pig, 2 guinea pigs per group;

[0173] 1.2 Injection dose and grouping

[0174] 1.2.1 Abnormal toxicity test: According to the inoculation dose stipulated in the abnormal toxicity inspection method of the three appendix XIIF items of the 2010 edition of "Chinese Pharmacopoeia": ...

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Abstract

The invention provides a multivalent group B meningococcal protein vaccine. The multivalent group B meningococcal protein vaccine is a multivalent combined vaccine comprising outer menbrane vesicle (OMV) proteins of group B meningococcus strain CMCC29356, strain CMCC29361, strain xrsw341215 having preservation number of CGMCC No.8982 and strain xrsw210902 having preservation number of CGMCC No.8981, and optionally comprises a medicinal excipient and / or an adjuvant. The multivalent group B meningococcal protein vaccine has wide cross protection antibody titers for prevention of group B epidemic cerebrospinal meningitis around the world, and has good cross protection effects on group A and group C epidemic cerebrospinal meningitis. The invention provides a whole production technology of the multivalent group B meningococcal protein vaccine. The production technology is suitable for large scale production. A research result shows that the multivalent group B meningococcal protein vaccine has good immunogenicity, reliable safety and stable immunization endurance.

Description

technical field [0001] The invention relates to a meningococcal vaccine and a preparation method thereof, in particular to a multivalent group B meningococcal protein vaccine and a preparation method thereof. Background technique [0002] Meningococcal meningitis (meningococcal meningitis) caused by Neisseria meningococcus (Nm) infection is a worldwide acute respiratory infectious disease, which still seriously endangers human health. It's children. Nm can be divided into 13 serogroups according to the differences in their capsular polysaccharide structures, and all serogroups can be pathogenic. Among them, diseases caused by Nm in groups A, B, C, Y, and W135 accounted for more than 95% of Nm diseases. [0003] Various monovalent (A or C), bivalent (A, C) and quadrivalent (ACYW135) vaccines based on meningococcal capsular polysaccharides and polysaccharide-protein combinations of groups A, C, Y, W135 are effective in the prevention of invasive disease It plays a very crit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/116A61K39/095A61P31/04C07K1/36C07K1/30C07K1/34C07K1/16C07K1/20C07K14/22C12N1/20
Inventor 王建华
Owner BEIJING SANROAD BIOLOGICAL PROD CO LTD
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