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

U19性传播感染合作研究中心（STI CRC），“北方大学 卡罗莱纳-衣原体疫苗倡议（UNC-CVI）”汇集了一个协同多学科小组， 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， 有效合作的历史，以支持包括疫苗抗原的疫苗开发管道 评估、动物模型中的疫苗测试和功效的人类相关性的鉴定。UNC-CVI STI CRC将通过三个项目实现我们的目标。项目1，人类对候选人的反应 衣原体抗原（Darville，Goonetilleke，Co-PI）将利用高度暴露于CT的女性的反应， 通过分析CD 4和CD 8应答来鉴定候选疫苗抗原。项目2，衣原体 小鼠和豚鼠的疫苗试验（Beagley和Goonetilleke，Co-PI）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中被证明是安全有效的，作为建立持久免疫的途径。 小鼠和豚鼠对衣原体攻击的免疫力。我们已经招募了合作专家， 詹纳研究所，他们将提供建议并生产表达衣原体的无复制能力的病毒载体 免疫原用于异源初免-加强策略，BlueWillow Biologics的专家将 建议和生产纳米乳液中的重组衣原体免疫原，Nanovax ®可用作 鼻内疫苗最后，项目3，衣原体易感性和疾病的生物标志物（O 'Connell 和Zheng，Co-PI）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， 通过支持确定最有可能从免疫接种中受益的个人， 疫苗试验招募并作为替代终点。这些项目将得到一个 行政核心和临床核心。行政核心将作为该中心的通信 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），将培养新的研究人员在性病疫苗研究，和生物统计 支持小组，将服务于所有项目和DRP获奖者。临床核心将识别和招募女性 感染性病或有感染性病风险的病人，并收集完成项目所需的临床标本。这些调查员， 项目和核心代表了技能和经验的独特组合，以解决重大的公众 健康问题。在完成这项计划后，我们预计已经确定了新的衣原体疫苗 临床试验和执照的可行性很高

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.