The Gonorrhea Vaccine Cooperative Research Center

ABSTRACT The overall goal of the Gonorrhea Vaccine Cooperative Research Center (GV CRC) is to advance promising vaccine candidates towards further preclinical development and clinical trials. The proposed GV CRC is organized around four Research Projects, which collectively will address the large research gap regarding correlates of vaccine-induced immunity against gonorrhea using human samples from individuals and mice vaccinated with the 4CMenB vaccine for which there is evidence of protection against gonorrhea (Project 1) and develop candidate gonorrhea vaccines against promising Ng surface molecules using vaccine platforms with proven safety and manufacturability, specifically OMV vaccines (Project 2), nanodisc-displayed protein subunit vaccines (Project 3) and epitope-tagged virus-like particle vaccines (Project 4). The choice of vaccine targets is based on sequence conservation, capacity to induce bactericidal antibodies (Abs), in vivo efficacy in the mouse model, and, or recognition by Abs from mice immunized with 4CMenB, which accelerates Ng clearance in the female mouse model of lower genital tract infection. Vaccine immunogens will be prepared by a centralized core (Core B) to ensure consistent and controlled preparations, and all vaccine candidates will be subjected to a systematic and rigorous evaluation process that uses state-of-the-art immunological assays (Cores C and D) and animal infection models (Core E) through the participation of four centralized Scientific Cores. An Administrative Core (Core A) will provide the infrastructure needed to facilitate communications between the different institutions within the center and with NIH/NIAID program staff, and coordinate teleconferences and meetings among the Project and Core leaders to foster data exchange, internal peer review and collaboration. A standing outside Scientific Advisory Board will review scientific progress in years 2 and 4, and determine which vaccines will be advanced for further pre-clinical development.