Clinical Core

临床试验核心将快速、高效、协调地开展CHAVI发起的疫苗一期和二期试验。 Core将提供以下功能：（1）I、II期临床方案设计； (2) 招募和留住志愿者受试者群体； (3) 评估候选疫苗的安全性和免疫原性； (4) 收集数据和临床样本； (5) 提供质量控制； (6)分析数据。临床试验核心将通过疫苗发现团队的成员资格，在候选疫苗开发的早期阶段进行互动，并通过在临床试验之前和涉及临床试验的开发过程中的积极互动。 在美国，核心将在布莱根妇女医院的临床研究设施进行疫苗试验，该设施也是哈佛艾滋病毒疫苗试验中心 (HVTU) 的所在地。研究将由 Raphael Dolin 博士领导的经验丰富的疫苗试验团队进行，该团队在 HVTN 研究中表现出色。临床试验核心还将与核心 B 中描述的 CHAVI 急性 HIV 感染网络密切合作，准备、培训和协调这些临床中心，根据需要进行 I 期和 II 期疫苗试验。临床试验核心还将协助核心 B 的研究人员根据需要为急性 HIV 感染研究的开展提供支持，特别是在获奖的第一年。临床试验核心将有能力每年进行两项 I 期研究或一项 II 期研究，可能 从该奖项的第二年开始。该核心将与 HIV 疫苗试验网络 (HVTN) 密切协调其活动，以利用其基础设施和数据分析能力，并根据需要扩大临床试验的规模。

The Clinical Trials Core will conduct phase I and II vaccine trials initiated by CHAVI in a rapid, efficient and coordinated manner. The Core will provide the following functions: (1) design of phase I and II clinical protocols; (2) recruit and retain volunteer subject populations; (3) assess safety and immunogenicity of vaccine candidates; (4) collect data and clinical samples; (5) provide quality control; (6) analyze data. The Clinical Trials Core will interact at early stages in the development of vaccine candidates through membership in Vaccine Discovery Teams, and through active interaction in the development process leading up to and involving clinical trials. In the U.S., the Core will carry out vaccine trials at the clinical studies facility based at Brigham and Women's Hospital, which is the site used for the Harvard HIV Vaccine Trials Unit (HVTU). Studies will be conducted by a highly experienced vaccine trials team led by Dr. Raphael Dolin, which has had a high level of performance in HVTN studies. The Clinical Trials Core will also work closely with the CHAVI Acute HIV Infection Network described in Core B to prepare, train, and coordinate those clinical sites to conduct phase I and II vaccine trials as needed. The Clinical Trials Core will also assist the investigators in Core B to provide support for the conduct of acute HIV infection studies as needed, particularly during the first year of the award. The Clinical Trials Core will have the capability to conduct two phase I or one phase II study annually, likely beginning in year 2 of the award. The Core will closely coordinate its activities with those of the HIV Vaccine Trials Network (HVTN) to take advantage of its infrastructure and data analysis capabilities and to expand the size of the clinical trials as warranted.