HIV VACCINE CLINICAL TRIALS UNIT

HIV疫苗临床试验单位

• 批准号: 6188866
• 负责人: PETER Farnum WRIGHT
• 金额: $ 203.16万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-06-01 至 2005-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6188866
• 关键词: AIDS; AIDS education /prevention; AIDS therapy; AIDS vaccines; Caribbean; HIV infections; MHC class I antigen; MHC class II antigen; Poxviridae; Venezuelan equine encephalitis virus; adeno associated virus group; antibody formation; antiviral antibody; clinical research; clinical trial phase I; cooperative study; cytokine; cytotoxic T lymphocyte; helper T lymphocyte; human immunodeficiency virus 1; human subject; human therapy evaluation; immunomodulators; interferon gamma; interleukin 2; interleukin 4; interleukin 5; leukocyte activation /transformation; neutralizing antibody; protein biosynthesis; tissue resource /registry; vaccine development; vector vaccine; virus protein

Development of an effective AIDS vaccine is critical to the ultimate control of the global HIV-1 epidemic. Evaluation of candidate AIDS vaccines in clinical trials is an essential part of this process and is central to the iterative approach required for improving vaccine immunogens and formulations. In this proposal we will state the goals of the Vanderbilt HIV Vaccine Trials Unit (HVTU), define the current state of AIDS vaccine development and critical scientific challenges and describe our plan for implementing and advancing future trials. The Vanderbilt HVTU application will include a consortium between Vanderbilt University and the Cornell University Research Unit in Haiti (GHESKIO) that will have the capacity to perform Phase I clinical trials of candidate AIDS vaccines and advance selected products to Phase II and Phase Ill evaluation. The investigators have extensive experience in the clinical evaluation of vaccines and also bring basic virology and immunology expertise that will contribute to the scientific leadership involved in developing vaccine immunogens, devising vaccine formulations and delivery vehicles, and evaluating immunogenicity, safety, and efficacy in preclinical studies. The investigators are also involved at the national and international level in defining the ethics of performing domestic and international vaccine trials which will be critical during the expansion of studies into developing countries. The focus of the Vanderbilt HVTU consortium will be on the evaluation of novel vaccines vectors (including Venezuelan Equine Encephalitis virus (VEE), adeno-associated virus (AAV), poxvirus, nucleic acid vaccines, and other constructs), the evaluation of cytokine adjuvants (such as IL-12), and combination regimens that incorporate mucosal immunization. Investigators in the Vanderbilt HVTU consortium are engaged at multiple scientific and policy levels of the AIDS vaccine development process, and involved in both domestic and international efforts to pursue the ultimate goal of preventing HIV- l infection and controlling the AIDS epidemic.

有效辅助疫苗的开发对于全球HIV-1流行的最终控制至关重要。在临床试验中对候选艾滋病疫苗的评估是此过程的重要组成部分，对于改善疫苗免疫原和配方所需的迭代方法至关重要。在此提案中，我们将陈述范德比尔特艾滋病毒疫苗试验部（HVTU）的目标，定义当前的艾滋病疫苗开发和批判性科学挑战，并描述我们实施和推进未来试验的计划。 Vanderbilt HVTU申请将包括范德比尔特大学和海地康奈尔大学研究部门（Gheskio）之间的财团，该联盟将有能力对候选艾滋病疫苗进行I期临床试验，并将选定的产品推进II期和相位不当评估。研究人员在疫苗的临床评估方面具有丰富的经验，还带来了基本的病毒学和免疫学专业知识，这将有助于涉及开发疫苗免疫力，设计疫苗配方和递送工具的科学领导力，并评估免疫原性，安全性和疗效。调查人员还参与了国家和国际一级，以定义进行国内和国际疫苗试验的伦理，这在扩展到发展中国家的研究期间至关重要。 Vanderbilt HVTU联盟的重点将放在新型疫苗载体（包括委内瑞拉马匹脑炎病毒（VEE），腺相关病毒（AAV），痘病毒，核酸疫苗和其他结构）的评估上免疫。范德比尔特HVTU财团的研究人员参与了艾滋病疫苗开发过程的多个科学和政策水平，并参与了国内和国际努力，以追求防止艾滋病毒感染和控制艾滋病流行的最终目标。