Plant-Made Microbicides and Mucosal Vaccines for STIs

描述（由申请方提供）：从生殖道粘膜表面排除感染原是STI杀微生物剂的关键目标。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接种，以实现女性生殖道中的保护性抗体浓度。该中心的一个独特之处将是使用绿色植物作为杀微生物剂（例如基于抗体的）和粘膜疫苗的多功能、高成本效益的生物制造系统。认识到获得性传播感染公共卫生计划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的工具进行生物制药生产。该提案涉及四个具体的关注领域。AzBio中心包括三个科学项目领域。 项目1的重点是多样化，表征和临床前评估的人单克隆抗体（huMab）保护免受病毒性STI。项目2专注于粘膜靶向免疫原的创建和临床前评估，以实现针对病毒STl的有效阴道抗体浓度。项目3侧重于被动和主动免疫的临床评价，以在女性生殖道中实现针对病毒性传播感染的稳健抗体浓度。 生产核心将为单克隆抗体和原型疫苗生产提供植物生物技术服务，以支持这三个项目。一个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监管地图，以及融合新兴技术的战略规划，以确保公共卫生界能够获得新的生物制药。这项研究的结果将确定一个分层系统的安全性和替代有效性的植物衍生的公共卫生产品的性传播感染。

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.