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[Research progress on immunogenicity evaluation of serogroup B meningococcal vaccine]
1Institute for Communicable Disease Prevention and Control,Chinese Center for Disease Control and Prevention, Beijing 102206, China.
Abstract:
Epidemic cerebrospinal meningitis (meningococcal meningitis) is an acute respiratory infectious disease with high mortality and serious sequelae. Meningococcal vaccine is an effective measure to prevent and control meningococcal meningitis. At present, group B meningococcal meningitis has become the main prevalent serum group in the world, including China. Meningococcal ACYW and other vaccines are mainly composed of capsular polysaccharides, while the main component of group B meningococcal vaccine is protein, including outer membrane vesicles (OMV) and recombinant protein vaccine. The methods for evaluating the immunogenicity of group B meningococcal vaccine include hSBA and alternative methods such as meningococcal antigen typing system (MATS), flow cytometric meningococcal antigen surface expression assay (MEASURE), genetic meningococcal antigen typing system (gMATS) and bexsero antigen sequence type (BAST). The evaluation of vaccine immunogenicity is the basis of vaccine development and clinical trial research, However, at present, there is no group B meningococcal vaccine in China. Therefore, in this paper, the research progress of immunogenicity evaluation of group B meningococcal vaccine has been reviewed, in order to provide technical guidance for the research and development of group B meningococcal vaccine, immunogenicity evaluation and clinical trial research in China.
Insights
Group B meningococcal meningitis is a global health threat. This review details immunogenicity evaluation methods for group B meningococcal vaccines, crucial for developing new vaccines in China.
Area of Science:
- Microbiology
- Vaccinology
- Epidemiology
Background:
- Meningococcal meningitis, particularly group B, poses a significant global health risk due to high mortality and sequelae.
- Current meningococcal vaccines (ACYW) target capsular polysaccharides, but group B strains require protein-based vaccines like outer membrane vesicles (OMV) or recombinant proteins.
- China currently lacks a group B meningococcal vaccine, highlighting an urgent need for development and evaluation.
Purpose of the Study:
- To review the research progress on immunogenicity evaluation methods for group B meningococcal vaccines.
- To provide technical guidance for the research, development, and clinical trials of group B meningococcal vaccines in China.
Main Methods:
- The review discusses established immunogenicity assays such as the human serum bactericidal assay (hSBA).
- It also covers alternative and emerging methods including Meningococcal Antigen Typing System (MATS), MEASURE, gMATS, and BAST.
- These methods assess the immune response to key vaccine components.
Main Results:
- The study identifies various methods for evaluating the immunogenicity of group B meningococcal vaccines.
- It highlights the importance of these evaluations as the foundation for vaccine development and clinical trials.
- The review underscores the lack of a group B meningococcal vaccine in China.
Conclusions:
- Effective immunogenicity evaluation is critical for advancing group B meningococcal vaccine development.
- The reviewed methods offer a framework for assessing vaccine efficacy and guiding future research in China.
- Establishing robust evaluation strategies will facilitate the introduction of a much-needed group B meningococcal vaccine.
