Harvard Medical School Vaccine Clinical Trials Unit

哈佛医学院疫苗临床试验单位

• 批准号: 7341116
• 负责人: Raphael Dolin
• 金额: $ 97.73万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-15 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7341116
• 关键词: Adenovirus Vector; Adjuvant; Award; Bisexual; Category Rating Scale; Clinical Investigator; Clinical Trials; Collaborations; Communities; Community Health Centers; Community Outreach; Dolin; Education; Employee; Enrollment; Evaluation; Gays; Goals; HIV; HIV vaccine; Health; Hospitals; Israel; Laboratories; Lead; Leadership; Lesbian; Medical center; Mucosal Immunity; Pharmacy facility; Phase III Clinical Trials; Play; Population; Principal Investigator; Procedures; Process; Research; Role; Sampling; Score; Site; Standards of Weights and Measures; System; Underrepresented Minority; Universities; Vaccine Clinical Trial; Vaccines; Woman; base; clinical research site; college; experience; interest; medical schools; member; novel; programs; transgender

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

描述（由申请人提供）： 该建议描述了哈佛医学院（HMS）疫苗临床试验单元（CTU），该试验由HMS的行政组成部分，Brigham医院的两个临床研究地点（CRS）和Fenway社区健康中心（FCH）组成，并由Beth Israel DeaConsess Medical Center（BIDMC）提供了支持。 CTU将隶属于疫苗网络，并代表了高度成功的哈佛大学HVTU的延续，该疫苗HVTU是HIV疫苗试验网络（HVTN）的主要入学单元（HVTN），在过去的三年中，该单元在网络评估系统中保持持续很高的分数，并且其成员在HVTN中发挥了重要的领导力。 CTU将由经验丰富的艾滋病毒疫苗领域经验丰富的临床研究人员领导，这些研究人员在过去五年中有效合作。拉斐尔·多林（Raphael Dolin）博士将担任CTU的首席研究员（PI）和Drs。 Lindsey Baden和Kenneth Mayer将分别用作BWH和FCH的CRS网站。 Dolin博士还将监督BIDMC的支持实验室。 拟议CTU组成部分之间的合作利用了每个站点的特殊优势，并导致了朝着疫苗试验网络目标的活动协同作用。 BWH CRS是一个基于大学的网站，与当地的大学人口，医学中心员工有牢固的联系，并具有广泛的研究计划。 FCH是一个基于社区的健康中心，与同性恋，女同性恋，双性恋和跨性别社区有着密切的联系，并且与代表人数不足的少数民族的社区建立了良好的关系。 BIDMC的实验室具有良好的样本处理程序，并且具有其他高度发达的HIV实验室能力。 CTU及其组件CRS已完全确定，以进行网络要求的广泛活动。这些活动在CTU的指导下完全集成，包括社区外展，招聘和教育计划，一个社区顾问委员会（CAB），单个普通药房，集中样本处理以及协调的质量管理。这两个CRS站点都通过哈佛大学HVTU开发了常见的标准操作程序（SOP）。 尽管该单元参与了广泛的HIV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。我们预测，哈佛大学HVTU将在当前奖项的第六年遵循176个主题，并在拟议奖励的第1年中至少146个受试者。因此，每年将遵循80至100名受试者。我们还预计，在进行第三阶段试验时，我们可以扩展到500名受试者进行III期试验。 管理组件