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) 卡罗莱纳-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/首席调查员(PI)在STI研究方面具有临床和基础研究专业知识，并 有效合作的历史，以支持包含疫苗抗原的疫苗开发流水线 评估，在动物模型中进行疫苗测试，以及确定与疗效相关的人类因素。北卡罗来纳大学-CVI STI CRC将通过三个项目实现我们的目标。项目1，人类对应聘者的回应 衣原体抗原(Darville、Goonetilleke、Co-Pis)将利用高度暴露于CT的妇女对 通过分析CD4和CD8反应确定候选疫苗抗原。项目2，衣原体 在小鼠和豚鼠(Beagley和Goonetilleke，Co-PI)身上进行的疫苗测试将探索两种疫苗的有效性 领先的T细胞疫苗模式已经在人类身上证明是安全有效的，作为建立持久的 小鼠和豚鼠对衣原体攻击的免疫力。我们招募了协作专家， Jenner研究所将为表达衣原体的复制能力不强的病毒载体提供建议并生成病毒载体 用于异源Prime-Boost策略的免疫原，以及BlueWillow Biologics的专家将 建议和制造纳米乳剂中的重组衣原体免疫原，纳米用作 鼻腔疫苗。最后，项目3，衣原体易感性和疾病的生物标记物(O‘Connell 和郑，Co-PI)解决了对生物标记物的关键需求，以加速合理的疫苗设计和测试， 通过支持确定最有可能从免疫中受益的个人，实现群体平衡 招募疫苗试验和充当代理终点。这些项目将由一个 行政核心和临床核心。行政核心将作为中心的沟通中心 中心，并将提供中心职能的行政和科学监督，包括发展 研究计划(DRP)，将培养STI疫苗研究的新研究人员，以及生物统计学 将为所有项目和DRP获奖者提供服务的支持小组。临床核心中心将确定和招募女性 并收集完成项目所需的临床标本。这些调查人员， 项目和核心代表了技能和经验的独特组合，以满足重要公众的需求 健康问题。在这项计划完成后，我们预计将识别出新的衣原体疫苗 拥有一条高度可行的临床测试和许可途径。