Harvard Medical School Vaccine Clinical Trials Unit

描述（由申请人提供）： 本提案描述了哈佛医学院（HMS）疫苗临床试验部门（CTU），该部门由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）的两个临床研究中心（CRS）组成，并由贝斯以色列女执事医疗中心（BIDMC）的一个处理实验室提供支持。CTU将隶属于疫苗网络，并代表了非常成功的哈佛HVTU的延续，该HVTU在过去三年中一直是HIV疫苗试验网络（HVTN）的主要招生单位，在网络评估系统中保持一贯的高分，其成员在HVTN中发挥重要的领导作用。 CTU将由在艾滋病毒疫苗领域经验丰富的临床研究人员领导，他们在过去五年中进行了有效的合作。Raphael Dolin博士将担任CTU的主要研究者（PI），Lindsey Baden博士和Kenneth Mayer博士将分别担任BWH和FCH的CRS研究中心PI。Dolin博士还将监督BIDMC的支持实验室。 拟议的技术股各组成部分之间的合作利用了每个地点的特殊优势，并导致为实现疫苗试验网络的目标而开展的活动的协同作用。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，并拥有广泛的研究计划。FCH是一个以社区为基础的健康中心，与男同性恋、女同性恋、双性恋和变性者社区有着密切的联系，并与代表性不足的少数群体社区建立了良好的关系。BIDMC的实验室有完善的样本处理程序，并具有其他高度发达的艾滋病毒实验室能力。 反恐股及其下属的中央登记系统已经完全建立，可以开展网络所要求的广泛活动。这些活动在CTU的指导下完全整合，包括社区外展，招募和教育计划，单一的社区咨询委员会（CAB），单一的公共药房，集中的样本处理和协调的质量管理。已通过哈佛HVTU为两个CRS研究中心制定了通用标准操作规程（SOP）。 虽然该股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HVTU将遵循176个科目在今年6目前的奖项，并在第一年的拟议奖项至少146个科目。因此，每年将在每次CRS时对80 - 100例受试者进行随访。我们还预计，我们可以扩大到招募500名受试者进行III期试验时，一个是进行。 行政部分

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