University of North Carolina - Chlamydia Vaccine Initiative (UNC-CVI)

北卡罗来纳大学 - 衣原体疫苗倡议 (UNC-CVI)

• 批准号: 10392970
• 负责人: Toni Darville
• 金额: $ 206.37万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10392970
• 关键词: Address; Adjuvant; Advanced Development; Animal Model; Antigens; Basic Science; Binding; Biological Markers; Biological Products; Biometry; Blood; CD8B1 gene; Cavia; Chad; Chlamydia trachomatis; Clinical; Clinical Research; Collaborations; Combined Vaccines; Communication; Development; Disease; Endocervix; Enrollment; Exhibits; Exposure to; Female; Female genitalia; Fostering; Genital; Genitalia; Goals; HIV; Health; Human; Immunity; Immunization; Individual; Infection; Infertility; Institutes; Knowledge; Licensure; Life; Mission; Modality; Mus; North Carolina; Outcome; Persons; Predisposition; Principal Investigator; Public Health; Recombinants; Recording of previous events; Regimen; Research; Research Personnel; Resistance; Risk; Route; Sexual Transmission; Sexually Transmitted Diseases; Specimen; Subunit Vaccines; Support Groups; Surrogate Endpoint; System; T cell response; T memory cell; T-Lymphocyte; Technology; Translating; United States National Institutes of Health; Universities; Vaccine Antigen; Vaccine Design; Vaccine Research; Vaccines; Viral Vector; Woman; chlamydia vaccine; clinical efficacy; disability; experience; immunogenicity; improved; men; multidisciplinary; nanoemulsion; novel; novel vaccines; pathogen; prevent; programs; protective efficacy; recruit; reproductive tract; research clinical testing; response; skills; transmission process; vaccine candidate; vaccine development; vaccine evaluation; vaccine trial

The U19 Sexually Transmitted Infections Cooperative Research Center (STI CRC), “University of North Carolina - Chlamydia Vaccine Initiative (UNC-CVI)” brings together a synergistic multidisciplinary group of project leaders/principal investigators (PI) with clinical and basic research expertise in STI research and a history of effective collaboration, to support a vaccine development pipeline comprising vaccine antigen assessment, vaccine testing in animal models, and identification of human correlates of efficacy. The UNC-CVI STI CRC will accomplish our goal through three projects. Project 1, Human Responses to Candidate Chlamydial Antigens (Darville, Goonetilleke, Co-PIs) will exploit responses of women highly exposed to CT to identify candidate vaccine antigens through profiling of CD4 and CD8 responses. Project 2, Chlamydial Vaccine Testing in Mice and Guinea Pigs (Beagley and Goonetilleke, Co-PIs) will explore the efficacy of two leading T cell vaccine modalities already proven safe and effective in humans, as a route to establishing lasting immunity to chlamydial challenge in mice and guinea pigs. We have enlisted collaborative experts at The Jenner Institute who will advise and generate replication-incompetent viral vectors expressing chlamydial immunogens for use in a heterologous prime-boost strategy, and experts at BlueWillow Biologics who will advise and manufacture recombinant chlamydial immunogens in nanoemulsion, Nanovax for use as intranasal vaccines. Finally, Project 3, Biomarkers of Chlamydial Susceptibility and Disease (O’Connell and Zheng, Co-PIs) addresses a critical need for biomarkers to accelerate rational vaccine design and testing, by supporting identification of individuals most likely to benefit from immunization, enabling balanced group recruitment for vaccine trials and serving as surrogate endpoints. These projects will be supported by an Administrative Core and a Clinical Core. The Administrative Core will serve as the Center’s communications hub and will provide administrative and scientific oversight of Center functions, including a Developmental Research Program (DRP) that will foster new investigators in STI vaccine research, and a Biostatistical Support Group that will serve all projects and DRP awardees. The Clinical Core will identify and enroll women with or at-risk for STI and collect clinical specimens required to complete the projects. These investigators, projects and cores represent a unique combination of skills and experience to address a significant public health problem. Upon completion of this program, we anticipate having identified novel chlamydial vaccines with a highly feasible path to clinical testing and licensure.

U19 性传播感染合作研究中心 (STI CRC)、“北方大学” 卡罗莱纳州 - 衣原体疫苗倡议 (UNC-CVI)”汇集了一个协同的多学科小组 项目负责人/主要研究者 (PI)，具有 STI 研究方面的临床和基础研究专业知识以及 有效合作的历史，以支持包含疫苗抗原的疫苗开发管道 评估、动物模型疫苗测试以及人体功效相关性的鉴定。 STI CRC 将通过三个项目来实现我们的目标：项目 1，人类对候选人的反应。 衣原体抗原（Darville、Goonetilleke、Co-PIs）将利用高度暴露于 CT 的女性的反应来 通过分析 CD4 和 CD8 反应来识别候选疫苗抗原 项目 2，衣原体。 小鼠和豚鼠疫苗测试（Beagley 和 Goonetilleke，Co-PI）将探讨两种疫苗的功效 领先的 T 细胞疫苗模式已被证明对人类安全有效，作为建立持久的途径 我们在小鼠和豚鼠中招募了合作专家。 詹纳研究所将提供建议并生成表达衣原体的无复制能力的病毒载体 用于异源初免-加强策略的免疫原，以及 BlueWillow Biologics 的专家，他们将 建议并生产纳米乳剂 Nanonovax 中的重组衣原体免疫原，用作 最后，项目 3，衣原体易感性和疾病的生物标志物（奥康奈尔） 和郑（Co-PIs））解决了对生物标志物的迫切需求，以加速合理的疫苗设计和测试， 通过支持识别最有可能从免疫接种中受益的个人，从而实现平衡的群体 这些项目将得到疫苗试验招募和替代终点的支持。 行政核心和临床核心 行政核心将作为中心的通讯中心。 中心，将为中心职能提供行政和科学监督，包括发展中心 研究计划 (DRP) 将培养 STI 疫苗研究的新研究者，以及生物统计 将为所有项目和 DRP 获奖者提供服务的支持小组将确定并招募女性。 患有性传播感染或有感染性传播感染风险的人并收集完成项目所需的临床标本。 项目和核心代表了技能和经验的独特组合，可以满足重要公众的需求 完成该计划后，我们预计已经发现了新型衣原体疫苗。 具有高度可行的临床测试和许可途径。