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: 10392972
• 负责人: Toni Darville
• 金额: $ 75.81万
• 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/10392972
• 关键词: Achievement; Aftercare; Antibiotic Therapy; Antigens; Bacterial Infections; Biological; Biological Markers; Biopsy Specimen; Blood; Blood specimen; CLIA certified; Caring; Cells; Cervical; Chlamydia; Chlamydia Infections; Chlamydia trachomatis; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collection; County; Data; Data Collection; Diagnosis; Diagnostic tests; Disease; Disease susceptibility; Ectopic Pregnancy; Endocervix; Endometrial; Endometrium; Enrollment; Ensure; Evaluation; Female; Female genitalia; Goals; Health; Hospitals; Human; Human Resources; Individual; Infection; Infectious Diseases Research; Infertility; Laboratories; Leadership; Mammalian Oviducts; Medical center; Mononuclear; Mycoplasma genitalium; Neisseria gonorrhoeae; North Carolina; Nucleic Acid Amplification Tests; Participant; Patient Recruitments; Pelvic Inflammatory Disease; Physical Examination; Population; Predisposition; Preventive vaccine; Procedures; Process; Protocols documentation; Provider; Regimen; Research; Research Institute; Research Personnel; Research Project Grants; Research Support; Risk; Sampling; Scientist; Sexual Transmission; Sexually Transmitted Diseases; Ships; Site; Specimen; Standardization; T cell response; Techniques; Testing; Trichomonas vaginalis; Universities; Vagina; Woman; Work; aged; base; chlamydia vaccine; chronic pelvic pain; clinical research site; cohort; design; disorder risk; experience; follow-up; member; novel vaccines; pathogen; prevent; programs; recruit; repository; reproductive; reproductive tract; research study; response; screening; socioeconomics; success; vaccine development; young woman

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.

C.沙眼（CT）是最常见的性传播细菌感染， 全球年度病例。发生在宫颈内膜，在约10%的感染妇女中，CT上升到宫颈内膜。 子宫内膜和输卵管可引起症状性或亚临床盆腔炎，导致 慢性盆腔疼痛不孕和宫外孕抗生素治疗是有限的，因为>70% 感染是无症状的，妇女可能会出现治疗后，不可逆的输卵管损伤， 发生了。性传播感染（STI）合作研究中心（CRC）U19的目标 北卡罗来纳大学衣原体疫苗倡议（UNC-CVI STI CRC）的提案是制定一项 一种新型疫苗，可预防女性生殖道CT Ascension，消除CT相关PID， 不孕最终目标是开发一种疫苗方案，完全防止生产性CT感染。帮助 为了实现这些目标，位于匹兹堡大学的拟议临床核心将与 研究项目1和研究项目3的科学家和工作人员提供全面的临床 分别评估妇女CT抗原和确定疾病生物标志物所需的研究支持 CT感染的风险或易感性。核心小组将对下列人员进行彻底、敏感的筛选和评价： 患有性传播感染或面临性传播感染风险的育龄妇女;安全有效地招募个人，并确保 招募和保留方案从一系列种族和社会背景中招募了多样化的临床人群， 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 对性传播感染病原体样本进行初步实验室检测。实现核心目标将是 以三种关键方式提供便利。第一，核心将使用临床研究中心和一些相同的人员， 参加了以前的核心支持项目，T细胞对衣原体（TRAC）的研究， 匹兹堡大学STI CRC。这些网站--阿勒格尼县卫生部门 传染病方案和马吉妇女医院门诊部（均用于登记）， 和生殖传染病研究股（也在马吉开展后续临床活动）， 女子医院）-是一个五分钟的车程。二、核心人才的招聘、留用和 （c）通过TRAC研究的数据收集程序，达到了所有征聘目标，保留率高。 第三，TRAC的库存样本为这一U19提案提供了初步数据，这些数据将补充 由核心收集样本以完成项目1和3。成功征聘和留住 UNC-CVI临床研究参与者和采集的人体样本数据， 由核心分配给中心科学家的这些数据将极大地确保项目1和3的成功， 大大有助于UNC-CVI的长期目标，开发C.沙眼