Center for Immunological Interventions against Gonorrhea (CIIG) - Modified Project Summary/Abstract Section SUMMARY Over 82 million Neisseria gonorrhoeae (Ng) infections occur globally and gonorrhea ranks second among notifiable infections reported to the CDC. Ng has a major impact on reproductive health, the well-being of newborns, and the transmission of the human immunodeficiency virus. Control relies on safe-sex counseling and identification and treatment of infected individuals, the latter of which is seriously challenged by the rapid evolution of antibiotic resistance in Ng. New interventions are needed to reduce the number of infections and curb the spread of resistant strains. The overall goal of the Center for Immunological Interventions against Gonorrhea (CIIG) is to advance a promising vaccine candidate through further preclinical development and into clinical trials. This goal will be accomplished by three Research Projects that are focused on developing i.) a combination meningococcal outer membrane vesicle (OMV) vaccine (VesiVax® IAMs-OMV-NgAg) containing promising recombinant Ng antigens using the VesiVax® liposome vaccine platform. The OMV portion of the vaccine is designed to induce broader reactivity against Ng strains; co-delivery of selected adjuvants (IAMs) and intradermal immunization through a patented microneedle patch will be optimized to induce robust protective responses (Projects 1 and 3); ii.) a peptide/virus-like protein immunogen to augment the VesiVax® IAMs-OMV-NgAg vaccine by inducing epitope-targeted antibodies that increase Ng susceptibility to host immune defenses by blocking mechanisms by which Ng to evades complement activation (Project 2). Three collaborative Scientific Cores will support the projects by providing state-of-the art measurements of immune responses (Core B), in vivo efficacy testing in mouse models of Ng reproductive tract infection (Core C), and centralized systems for data management, study design, data analysis, and pre-IND activities (Core D). An Administrative Core (Core A) will provide the infrastructure needed to facilitate communications between the CIIG and NIH, and coordinate teleconferences among the Project and Core Leaders to foster data exchange, internal peer review and intra-center collaborations. A standing Scientific Advisory Board will review scientific progress each year and determine which products will be advanced for further pre-clinical development. Pre-IND activities will begin in Year 4 under a regulatory strategy provided by Core D.
