Plant-Made Microbicides and Mucosal Vaccines for STIs

描述（由申请人提供）：从生殖道粘膜表面排除传染性病原体是STI杀菌剂的关键目标。该中心将分析粘膜抗体作为排斥机制，以及互补的被动和主动免疫，以达到女性生殖道的保护性抗体浓度。该中心的一个独特之处在于使用绿色植物作为杀菌剂（如基于抗体的）和粘膜疫苗的多功能高成本效益生物制造系统。认识到参与性传播感染公共卫生项目将需要低成本和高能力的预防技术，该中心利用植物生物技术工具生产生物制药。该提案涉及4个具体的兴趣领域。AzBio中心包括三个科学项目区。

DESCRIPTION (provided by applicant): 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.