SAN FRANCISCO HIV VACCINE CLINICAL TRAILS UNIT

旧金山 HIV 疫苗临床试验单位

• 批准号: 7111311
• 负责人: Susan Buchbinder
• 金额: $ 165.05万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-06-01 至 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7111311
• 关键词: AIDS; AIDS education /prevention; AIDS therapy; AIDS vaccines; HIV infections; MHC class I antigen; MHC class II antigen; antibody formation; antiviral antibody; bisexual; clinical research; clinical trial phase I; cooperative study; cytotoxic T lymphocyte; helper T lymphocyte; human immunodeficiency virus 1; human subject; human therapy evaluation; interferon gamma; interleukin 2; interleukin 4; interleukin 5; leukocyte activation /transformation; male; neutralizing antibody; protein biosynthesis; tissue resource /registry; urban area; vaccine development; virus protein

A clinical trials network is an essential component of an overall program to develop and test candidate HIV vaccines, and needs the scientific leadership and practical capacity to take products expeditiously from Phase I studies through efficacy trials. This application brings together participants in the UCSF AIDS Research Institute (ARI) who are leaders n the fields of virology, immunology, epidemiology, and behavioral science to design and conduct HIV vaccine trials. )ver the last decade, we have carried out pre-clinical and efficacy trial preparedness studies, single- and multi-site Phase I - III HIV vaccine trials, and laboratory support f6r all domestic and international HIV Network for Prevention Trials HIVNET) protocols. From this group of ARI investigators, the HVTN can expect expertise and leadership in the design, implementation, and laboratory support of vaccine trials. We work closely with dedicated community members to address issues of importance in the conduct of vaccine trials, and propose in this application to link domestic with international community advisory boards. "Sister" sites will jointly address scientific, operational and ethical issues to help ensure that domestic and international agendas advance cooperatively. We also bring to this application substantial capacity to enroll high risk men who have sex with men (MSM) for inclusion in Phase II, Phase IIB, and Phase III vaccine trials. Data from previous studies demonstrate our success in identifying and enrolling diverse cohorts of high risk MSM in vaccine and other prevention trials; HIV seroincidence among our participants has been consistently in excess of 2 per 100 person1years, after administration of enhanced risk reduction counseling and decreases in reported risk behavior over the course of these trials. These high seroincidence rates are likely the joint result of high HIV seroprevalence in the MSM community (estimated at 30%), and identification f participants with substantial risk behavior. We have expanded our capacity to enroll high-risk MSM by inclusion of experienced sites in other Northern California locations including Santa Clara, Sacramento, Marin, and Sonoma counties. We will work within the HVTN to refine and implement a comprehensive scientific agenda for evaluating HIV vaccines, and bring substantial expertise and capacity to carry out such trials in the San Francisco HIV Vaccine Clinical Trials Unit.

临床试验网络是开发和测试候选艾滋病毒疫苗的整体计划的重要组成部分，需要科学领导力和实践能力，以通过有效试验从I期研究中快速采用产品。该应用程序汇集了UCSF AIDS研究所（ARI）的参与者，他们是病毒学，免疫学，流行病学和行为科学领域的领导者，以设计和进行HIV疫苗试验。 ）在过去的十年中，我们已经进行了临床前和效力试验准备研究，单位和多站点I-III-III期HIV疫苗试验以及实验室支持F6R F6R所有国内和国际HIV HIV网络HIVNET方案）方案。 HVTN从这组ARI调查人员那里期望疫苗试验的设计，实施和实验室支持方面的专业知识和领导能力。我们与专门的社区成员紧密合作，以解决进行疫苗试验的重要性问题，并建议在此申请中与国际社区咨询委员会联系起来。 “姐妹”站点将共同解决科学，运营和道德问题，以帮助确保国内和国际议程合作。我们还带来了这一应用程序，可以将与男性发生性关系的高风险男性（MSM）纳入II期，IIB期和III期疫苗试验。先前研究的数据表明，我们成功地识别和招募了疫苗和其他预防试验中高风险MSM的各种同类。在这些试验过程中，我们的参与者中的HIV血清持续时间始终超过每100人10年的2年。这些高血清含量率可能是MSM社区高HIV血清阳性率的共同结果（估计为30％），并且具有实质性风险行为的识别参与者。我们通过在加利福尼亚州其他北部其他地区包括经验丰富的地点来扩大了高危MSM的能力，包括圣克拉拉，萨克拉曼多，马林和索诺玛县。我们将在HVTN内工作，以完善和实施全面的科学议程来评估艾滋病毒疫苗，并在旧金山HIV HIV疫苗临床试验单元中带来大量的专业知识和能力来进行此类试验。