Harvard Medical School Vaccine Clinical Trials Unit

描述(由申请人提供)： 这份提案描述了哈佛医学院(HMS)疫苗临床试验股(CTU)，它由HMS的一个行政部门、布里格姆妇女医院(BWH)和芬威社区卫生中心(FCH)的两个临床研究站点(CRSS)组成，并由贝丝以色列女执事医疗中心(BIDMC)的处理实验室提供支持。CTU将隶属于疫苗网络，是非常成功的哈佛大学的延续，过去三年来，哈佛大学一直是艾滋病毒疫苗试验网络(HVTN)的牵头登记单位，在网络评估系统中保持高分，其成员在HVTN中发挥着重要的领导作用。 CTU将由艾滋病毒疫苗领域经验丰富的临床调查人员领导，他们在过去五年中进行了有效的合作。拉斐尔·多林博士将担任CTU的首席调查员，林赛·巴登博士和Kenneth Mayer博士将分别担任BWH和FCH的CRS现场调查员。多林博士还将负责BIDMC的支持实验室。 拟议的CTU各组成部分之间的合作利用了每个地点的特殊优势，并产生了朝着疫苗试验网络目标的活动的协同效应。BWH CRS是一个以大学为基础的网站，与当地大学人口、医疗中心员工有着密切的联系，并拥有基础广泛的研究项目。FCH是一个以社区为基础的健康中心，与男同性恋、女同性恋、双性恋和变性人社区有着密切的联系，并与代表不足的少数族裔社区发展良好的关系。BIDMC的实验室有完善的样本处理程序，也有其他高度发达的艾滋病毒实验室能力。 全面建立了反恐股及其组成部分中央支助系统，以开展该网络所需的广泛活动。这些活动在反恐联盟的指导下完全整合，包括社区外联、招聘和教育计划、单一社区咨询委员会(CAB)、单一共同药房、集中样品处理和协调质量管理。通过哈佛交通大学为两个CRS站点制定了共同标准作业程序(SOP)。 虽然该单位参与了广泛的艾滋病毒疫苗试验，但CTU对腺病毒载体、新型佐剂和粘膜免疫的研究特别感兴趣。我们预计哈佛高等交通大学将在当前奖项的第六年跟踪176门科目，在拟议的第一年至少跟踪146门科目。因此，每个CRS每年将跟踪80到100名受试者。我们还预计，如果进行第三阶段试验，我们可以扩大到招募500名受试者参加第三阶段试验。 管理组件

DESCRIPTION (provided by applicant): This proposal describes the Harvard Medical School (HMS) Vaccine Clinical Trials Unit (CTU), which is comprised of an administrative component at HMS, two Clinical Research Sites (CRSs) at Brigham and Women's Hospital (BWH) and Fenway Community Health Center (FCH), and is supported by a processing laboratory at Beth Israel Deaconess Medical Center (BIDMC). The CTU will be affiliated with the Vaccine Network and represents a continuation of the highly successful Harvard HVTU which has been the lead enrolling unit in the HIV Vaccine Trials Network (HVTN) for the past three years, which maintains consistently high scores in the Network Evaluation System, and whose members play important leadership roles in the HVTN. The CTU will be led by highly experienced clinical investigators in the field of HIV vaccines who have collaborated effectively for the past five years. Dr. Raphael Dolin will serve as Principal Investigator (PI) for the CTU, and Drs. Lindsey Baden and Kenneth Mayer will serve as CRS site-PIs for BWH and FCH respectively. Dr. Dolin will also oversee the supporting laboratory at BIDMC. The collaboration among the components of the proposed CTU takes advantage of the special strengths of each site and results in a synergy of activities toward the goals of the Vaccine Trials Network. The BWH CRS is a university-based site with strong ties to local college populations, medical center employees, and has broad-based research programs. FCH is a community-based health center with strong ties to gay, lesbian, bisexual, and transgender communities and with well developed relationships with communities of underrepresented minorities. The laboratory at BIDMC has well-established sample processing procedures and also has other highly developed HIV laboratory capabilities. The CTU and its component CRSs are fully established to carry out the broad spectrum of activities required by the Network. These activities are fully integrated under the guidance of the CTU, and include community outreach, recruitment, and education programs, a single community advisory board (CAB), a single common pharmacy, centralized sample processing, and coordinated quality management. Common standard operating procedures (SOPs) have been developed through the Harvard HVTU for both CRS sites. While this Unit has participated in a broad spectrum of HIV vaccine trials, the CTU has particular interest in studies of adenovirus vectors, novel adjuvants, and mucosal immunity. We project that the Harvard HVTU will follow 176 subjects in year 6 of the current award, and at least 146 subjects in year 1 of the proposed award. Thus, 80 to 100 subjects will be followed at each CRS annually. We also anticipate that we could expand to enroll 500 subjects for a Phase III trial when one is undertaken. ADMINISTRATIVE COMPONENT