Clinical Research Core

描述：拟议IPCAVD项目临床研究核心的目标是在项目内开展涉及人类受试者的所有研究：一项关于创新型重组修饰安卡拉痘苗（MVA）多支系、多基因HIV-1疫苗的安全性、耐受性和免疫原性的I期临床试验，以及两项人类皮肤微磨皮的探索性研究，以接触表皮抗原呈递细胞，增强免疫原性，并更安全地给药HIV疫苗。临床研究核心将确保IPCAVD项目内的所有临床研究活动按照涉及人类受试者的研究安全和道德行为的最高标准进行，并符合GCP、NIH和FDA的要求和指导方针。核心将促进I期疫苗试验和微磨皮研究的临床方面，准备机构审查委员会申请和知情同意文件，招募研究志愿者，获得知情同意，筛选潜在志愿者是否适合特定研究，管理研究疫苗，获得适当的临床标本用于免疫学研究，并监测研究志愿者以最大限度地提高其安全性。临床研究核心将与参与单个研究项目1-3、项目协调和产品开发核心以及免疫学核心的研究人员密切互动，以确保在基础、非人类灵长类动物和临床研究活动之间建立高度互动和有效的桥梁。此外，该中心将确保所有合作调查人员都能接受科学教育

CORE B DESCRIPTION: The goal of the Clinical Research Core of the proposed IPCAVD Program is to conduct all studies involving human subjects within the Program: a phase I clinical trial of the safety, tolerability and immunogenicity of innovative recombinant modified vaccinia Ankara (MVA) multiclade, multigene HIV-1 vaccines and two exploratory studies of microdermabrasion of the skin in humans to access epidermal antigen presenting cells for enhanced immunogenicity and safer administration of HIV vaccines. The Clinical Research Core will ensure that all clinical research activities within this IPCAVD Program are conducted according to the highest standards for safe and ethical conduct of research involving human subjects and in keeping with GCP, NIH and FDA requirements and guidelines. The Core will facilitate the clinical aspects of the phase I vaccine trial and microdermabrasion studies, prepare Institutional Review Board applications and informed consent documents, recruit study volunteers, obtain informed consent, screen potential volunteers for their suitability for specific studies, administer study vaccines, obtain appropriate clinical specimens for immunologic studies, and monitor study volunteers to maximize their safety. The Clinical Research Core will interact closely with investigators involved in individual research Projects 1-3, the Project Coordination and Product Development Core, and the Immunology Core to ensure that a highly interactive and effective bridge is established between basic, non-human primate and clinical research activities. In addition, the Core will ensure that all collaborating investigators receive education in appropriate standards for protection of human subjects involved in research studies.