Clinical Core

临床试验核心将以快速、高效和协调的方式进行由CHAVI发起的I期和II期疫苗试验。该中心将提供以下职能：(1)设计第一阶段和第二阶段临床方案；(2)招募和保留志愿者受试者；(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加入疫苗发现团队，以及通过在导致和涉及临床试验的开发过程中的积极互动，在候选疫苗开发的早期阶段进行互动。 在美国，Core将在布里格姆妇女医院的临床研究机构进行疫苗试验，哈佛大学艾滋病毒疫苗试验单位(HVTU)就是在这里进行的。研究将由拉斐尔·多林博士领导的一个经验丰富的疫苗试验小组进行，该小组在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急性艾滋病毒感染网络密切合作，准备、培训和协调这些临床站点，以根据需要进行I期和II期疫苗试验。临床试验核心还将协助核心B的研究人员在需要时为进行急性艾滋病毒感染研究提供支持，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个第一阶段或一个第二阶段的研究，可能 从获奖的第二年开始。核心中心将密切协调其与艾滋病毒疫苗试验网络(HVTN)的活动，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.