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

沙眼衣原体(CT)是最常见的性传播细菌感染，估计有1亿人 全球每年的病例。发生在宫颈内，在~10%的感染妇女中，CT上升到 可引起症状性或亚临床盆腔炎的子宫内膜和输卵管，导致 到慢性盆腔疼痛、不孕不育和宫外孕。抗生素治疗是有限的，因为70%的 感染是无症状的，妇女可能在不可逆转的输卵管损伤后接受治疗。 发生了。性传播感染(STI)合作研究中心(CRC)U19的目标 建议，“北卡罗来纳大学-衣原体疫苗倡议(UNC-CVI STI CRC)”，是开发一种 一种新型疫苗，可防止CT在女性生殖道内上升，消除CT相关的PID和 不孕不育。最终目标是开发一种完全预防产生性CT感染的疫苗方案。帮助 为了实现这些目标，拟议的临床核心，总部设在匹兹堡大学，将与 研究项目1、研究项目3的科研人员为临床提供全面的 分别需要研究支持来评估女性的CT抗原和确定疾病的生物标记物 CT感染的风险或易感性。该核心将对以下各项进行彻底、敏感的筛选和评估 有性传播感染或有性传播感染风险的育龄妇女；安全和有效地招募个人并确保 招募和保留方案招募了来自一系列种族和社会- 两个项目的经济背景；从参与者那里收集信息和临床样本；以及 对STI病原体样本进行初步实验室检测。核心目标的实现将是 在三个关键方面提供了便利。首先，核心将使用临床站点和一些相同的人员 参与了上一个核心资助的项目，即T细胞对衣原体的反应(TRAC)研究 匹兹堡大学STI CRC。这些网站-阿勒格尼县卫生局 传染病方案和玛吉-妇女医院的门诊(都是为了登记)， 和生殖传染病研究股(用于后续临床活动，也在马吉岛-- 妇女医院)-距离酒店只有五分钟的车程。第二，核心将聘用招聘、留住和 核心预算资源调拨目标研究的数据收集程序达到了所有征聘目标，保留率很高。 第三，来自TRAC的银行样本导致了这项U19提案的初步数据，它们将补充 核心部门为完成项目1和项目3而收集的样本。成功招聘和保留 UNC-CVI临床研究参与者和来自收集和 由核心科学家分发给中心的科学家将极大地确保项目1和3的成功，并将 为联合国儿童基金会开发沙眼衣原体预防性疫苗的长期目标做出了重大贡献。

C. trachomatis (CT) is the most common sexually transmitted bacterial infection with an estimated 100 million annual cases worldwide. Arising in the endocervix, in ~10% of infected women CT ascends to the endometrium and oviducts where it can cause symptomatic or subclinical pelvic inflammatory disease, leading to chronic pelvic pain, infertility, and ectopic pregnancy. Antibiotic treatment is limited because >70% of infections are asymptomatic, and women may present for treatment after irreversible oviduct damage has occurred. The goal of this Sexually Transmitted Infections (STI) Cooperative Research Center (CRC) U19 proposal, “University of North Carolina-Chlamydia Vaccine Initiative (UNC-CVI STI CRC),” is to develop a novel vaccine that prevents CT ascension in the female genital tract, eliminating CT-associated PID and infertility. The ultimate goal is to develop a vaccine regimen that fully prevents productive CT infection. To help achieve these goals, the proposed Clinical Core, based at the University of Pittsburgh, will work closely with the scientists and staff of Research Project 1 and Research Project 3 to provide the comprehensive clinical research support needed to, respectively, evaluate CT antigens in women and identify biomarkers of disease risk or susceptibility during CT infection. The core will conduct thorough, sensitive screening and evaluation of reproductive-aged women with or at-risk for STIs; safely and efficiently enroll individuals and ensure that recruitment and retention protocols enroll a diverse clinical population from an array of ethnic and socio- economic backgrounds for the two projects; collect information and clinical specimens from participants; and conduct initial laboratory testing of samples for STI pathogens. Achievement of the core’s goals will be facilitated in three critical ways. One, the core will use the clinical sites and some of the same personnel that participated in a previous core-supported project, the T Cell Response Against Chlamydia (TRAC) Study of the University of Pittsburgh STI CRC. These sites -- the Allegheny County Health Department Sexually Transmitted Diseases Program and the Ambulatory Clinic at Magee-Womens Hospital (both for enrollment), and the Reproductive Infectious Diseases Research Unit (for follow-up clinical activities, also in Magee- Womens Hospital) – are a five minutes’ drive apart. Two, the core will employ the recruitment, retention and data collection procedures from the TRAC Study, which met all recruitment targets and had high retention. Three, banked samples from TRAC led to preliminary data for this U19 proposal, and they will supplement the samples to be gathered by the core to complete Projects 1 and 3. The successful recruitment and retention of UNC-CVI clinical research participants and the data originating from the human samples collected and distributed by the core to Center scientists will greatly ensure the success of Projects 1 and 3 and will significantly contribute to the UNC-CVI’s long-term goal to develop a preventative vaccine for C. trachomatis.