The Gonorrhea Vaccine Cooperative Research Center

淋病疫苗合作研究中心

• 批准号: 10362587
• 负责人: Ann E. Jerse
• 金额: $ 212.17万
• 依托单位: HENRY M. JACKSON FDN FOR THE ADV MIL/MED
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-26 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10362587
• 关键词: Address; Animals; Antibiotic Resistance; Antibodies; Antigens; Clinical Trials; Collaborations; Communication; Ensure; Epitopes; Evaluation; Female; Fostering; Goals; Gonorrhea; Human; Immunize; Immunology procedure; Individual; Infection; Infrastructure; Institution; Modeling; Mus; National Institute of Allergy and Infectious Disease; Peer Review; Preparation; Process; Protein Subunits; Public Health; Research; Research Project Grants; Safety; Sampling; Subunit Vaccines; Surface; Teleconferences; United States National Institutes of Health; Vaccinated; Vaccines; Virus-like particle; Work; bactericide; base; data exchange; gonorrhea vaccine; in vivo; manufacturability; meetings; mouse model; nanodisk; preclinical development; prevent; programs; reproductive tract; vaccine candidate; vaccine development; vaccine platform; vaccine-induced immunity

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.

抽象的 淋病疫苗合作研究中心（GV CRC）的总体目标是促进有希望的 候选疫苗的进一步临床前开发和临床试验。拟议的GV CRC是 围绕四个研究项目组织，该项目将共同解决有关的较大研究差距 使用来自个体和小鼠的人类样品，疫苗诱导对淋病的免疫力的相关性 用4CMENB疫苗接种了疫苗，有证据表明促淋病（项目1）和 使用带有疫苗的疫苗平台开发候选淋病疫苗，以防止有希望的NG表面分子 经过验证的安全性和制造性，特别是OMV疫苗（项目2），纳米散发蛋白质亚基 疫苗（项目3）和表位标记的病毒样颗粒疫苗（项目4）。疫苗目标的选择是 基于序列保守性，诱导杀菌抗体（ABS）的能力在小鼠中的体内功效 模型，或或通过ABS识别4厘米免疫的小鼠，这加速了NG清除率 下生殖道感染的雌鼠模型。疫苗免疫原会由集中核心制备 （核心B）确保一致和受控的准备工作，所有候选疫苗都将遭受A 使用最先进的免疫学测定（核C和D）的系统和严格评估过程 和动物感染模型（核心E）通过四个集中的科学核心参与。一个 行政核心（核心A）将提供促进沟通所需的基础架构 中心内以及NIH/NIAID计划人员的不同机构，并协调电视会议和 该项目和核心领导者之间的会议，以促进数据交换，内部同行评审和协作。 一个站在外部科学咨询委员会将审查第2和4年的科学进步，并确定哪个 疫苗将用于进一步的临床前开发。