Multivalent group b meningococcal protein vaccine and preparation method thereof

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...

AI Technical Summary

Problems solved by technology

However, there is still no international universal meningococcal group B OMV vaccine

[0025] 2. Limitations of the protective coverage of OMV vaccines

The MenB OMV vaccine has been successfully used to control the epidemic and outbreak of the disease, but its effectiveness is limited to the control of vaccine-type and subtype MenB disease outbreaks, and its effectiveness is limited for diseases caused by different types and subtypes of MenB

[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

The prevalence of group B Nm PorA types in different countries is different, and the coverage of PorA strains of 4C MenB vaccine is affected by the PorA types of different circulating group B strains, which has limitations

[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

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