Background
Invasive meningococcal disease (IMD), caused by Neisseria meningitidis, remains a serious global health threat. Serogroup B N.meningitidis (MenB) is a major cause of disease in many regions, including Asia. Current OMV-based MenB vaccines have demonstrated effectiveness but face limitations such as reactogenicity, restricted strain coverage due to antigen loss during detergent extraction, and complex manufacturing processes. These challenges highlight the need for next-generation OMV vaccine technologies.
Methods
DX-104 is a genetically engineered OMV vaccine candidate designed to present multiple protective antigens within a single OMV chassis. Genetic engineering enables antigen expression without detergent extraction, preserving native antigen structures. Preclinical evaluation included monocyte activation tests (MAT) for innate immune activation and serum bactericidal assays with human complement (hSBA) to assess functional antibody responses. Manufacturing scalability and OMV purity were also evaluated.
Results
DX-104 demonstrated lower innate immune activation compared with a marketed OMV MenB vaccine in MAT assays. hSBA analyses indicated broad bactericidal activity against globally prevalent meningococcal clonal complexes. Scalable manufacturing was demonstrated at the 100-L level, yielding more than one million doses per batch with high OMV purity. In addition, a dual-OMV candidate showed broadly protective response against serogroups A, B, C, W, X, and Y strains in SBA studies.
Conclusions
DX-104 represents a next-generation OMV vaccine candidate with promising safety, broad strain coverage, and scalable manufacturing potential. The OMV platform may also support the development of universal meningococcal vaccines providing broader protection across multiple serogroups.