Plant-Made Microbicides and Mucosal Vaccines for STIs

描述(由申请人提供)：排除生殖道粘膜表面的感染性物质是STI杀微生物剂的一个关键目标。该中心将分析粘膜抗体作为排斥机制，并补充被动和主动免疫，以实现女性生殖道中保护性抗体浓度。该中心的一个独特特点是使用绿色植物作为杀菌剂(例如抗体)和粘膜疫苗的多功能、高成本效益的生物制造系统。认识到获得STI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进行生物制药生产。这项提案涉及4个具体感兴趣的领域。AzBio中心包括三个科学项目区。 项目1的重点是预防病毒性性传播感染的人类单克隆体的多样化、特性和临床前评估。项目2的重点是创建和临床前评估粘膜靶向免疫原，以达到有效的抗病毒STL的阴道抗体浓度。项目3的重点是对被动免疫和主动免疫进行临床评估，以在女性生殖道实现强大的抗体浓度，以对抗病毒性性传播感染。 生产核心将为单抗和疫苗原型生产提供植物生物技术服务，以支持这三个项目。行政核心将监督和协调所有项目，包括确定技术临床评估的管理地图，以及战略规划，以融合新兴技术，以确保公共卫生界可以获得新的生物制药。这项研究的结果将确定用于性传播感染的植物来源公共卫生产品分层系统的安全性和替代有效性。

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.