Exclusion of infectious agents from mucosal surfaces of the reproductive tract is a key objective of STI microbicides. The center will analyze mucosal antibodies as mechanisms of exclusion, and complimentary passive and active immunizations to achieve protective antibody concentrations in the female reproductive tract. A unique feature of this center will be the use of green plants as versatile highly cost-effective biomanufacturing systems for microbicides (e.g. antibody-based) and mucosal vaccines. Recognizing that access to STI public health programs will require low-cost and high capacity prevention technologies, this center utilizes the tools of plant biotechnology for biopharmaceutical production. This proposal addresses 4 specific areas of interest. Three scientific project areas are included in the AzBio Center. Project 1 focuses on diversification, characterization and preclinical evaluation of human monoclonals (huMabs) protective against viral STIs. Project 2 focuses on creation and preclinical evaluation of mucosally targeted immunogens to achieve effective vaginal antibody concentrations against viral STls. Project 3 focuses on the clinical evaluation of passive and active immunization to achieve robust antibody concentrations in the female reproductive tract against viral STIs. A Production Core will provide plant biotechnology services for Mabs and prototype vaccine production to support the three projects. An Administrative Core will oversee and coordinate all of the projects, including defining the regulatory map for clinical evaluation of the technologies, and strategic planning to blend emerging technologies to ensure that new biopharmaceuticals are accessible to the public health community. The outcomes of this study will define the safety and surrogate effectiveness of a layered system of plant-derived public health products for STIs.
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