SDMC: HIV Vaccine Trials Network

描述(由申请人提供)：本申请继续作为艾滋病毒疫苗试验网络(HVTN)的统计和数据管理中心(SDMC)，是由HVTN领导小组组成的三项申请之一。为了实现RFA-AI-12-012中描述的总体科学目标，开发安全有效的艾滋病毒疫苗，HVTN SDMC科学议程包括以下目标：目标1，通过应用最佳数据和临床管理实践，坚持临床数据交换标准，并实施最新技术，提供高质量的可靠数据管理和安全监测，并不断提高质量和效率；目标2，设计、监测和分析评估候选艾滋病毒疫苗方案的安全性和免疫原性的疗效前试验；目标3，开发和实施用于测量疫苗的免疫分析的数据处理和分析的工具和方法 免疫原性；目标4，改进和实施新的2b阶段概念测试和第3阶段许可试验设计，主要目的是评估预防艾滋病毒感染的疫苗效力； 目标5，改进和实施新的定量方法，以评估和开发预防艾滋病毒感染和疾病进展的早期生物标记物的免疫相关性，用于显示疗效的方案；目标6，与其他全国抗炎网络合作，说明非疫苗预防方式，以实现目标2至5的目标，并共同进行联合方案试验；目标7，进行临床试验，以评估艾滋病毒免疫预防的单抗以及结核病和丙型肝炎疫苗。国家艾滋病预防控制中心在全球艾滋病毒疫苗和预防研究的设计、实施和分析方面拥有丰富的经验。我们建议用于数据收集、管理、监测和分析的系统已根据GCDMP、21 CFR Part 11和GCP进行了良好的测试，并将符合CDISC标准。此外，SDMC的统计学家和计算生物学家将开发新的定量方法，以提高拟议的艾滋病毒疫苗试验计划的效率、严密性和科学尖锐性。 相关性：据估计，全球有3400万艾滋病毒携带者，每年发生270万新感染病例(2011年联合国艾滋病规划署)。尽管最近在生物医学干预方面取得了进展，以降低感染艾滋病毒的风险，但消除这一流行病将需要安全和有效的 艾滋病疫苗。只有通过以最高的科学、伦理和监管标准进行的人体临床试验，艾滋病毒疫苗的目标才能实现。

DESCRIPTION (provided by applicant): This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Vaccine Trials Network (HVTN) is one of three applications comprising the Leadership Group of the HVTN. To address the overall scientific goal described in RFA-AI-12-012, the development of a safe and effective HIV vaccine, the HVTN SDMC scientific agenda includes the following aims: Aim 1, to provide high quality secure data management and safety monitoring and to continually improve quality and efficiency by applying best data and clinical management practices, adhering to clinical data interchange standards, and implementing state-of-the-art technologies; Aim 2, to design, monitor, and analyze pre-efficacy trials that evaluate the safety and immunogenicity of candidate HIV vaccine regimens; Aim 3, to develop and implement tools and methods for data processing and analysis of immunological assays used for measuring vaccine immunogenicity; Aim 4, to refine and implement novel Phase 2b test-of-concept and Phase 3 licensure trial designs with primary objective to assess vaccine efficacy to prevent HIV infection; Aim 5, to refine and implement novel quantitative methods for assessing and developing immune correlates of protection against HIV infection and early biomarkers of disease progression for regimens showing efficacy; Aim 6, in collaboration with other NIAD networks, to account for non-vaccine prevention modalities in meeting the objectives of Aims 2 through 5 and to co-conduct combination regimen trials; Aim 7, to conduct clinical trials to assess monoclonal antibodies for HIV immunoprophylaxis and vaccines for TB and HCV. The SDMC has extensive experience in the design, conduct and analysis of global HIV vaccine and prevention studies. The systems we propose to use for data collection, management, monitoring and analysis are well-tested, in accordance with GCDMP, 21 CFR Part 11 and GCP, and will comply with CDISC Standards. In addition, SDMC statisticians and computational biologists will develop novel quantitative methodologies to increase efficiency, rigor, and scientific incisiveness of the proposed program of HIV vaccine trials. RELEVANCE: 34 million people globally are estimated to be living with HIV, and 2.7 million new infections occur annually (2011 UNAIDS). Despite recent advances in biomedical interventions that reduce the risk of HIV acquisition, eliminating the pandemic will require a safe and effective HIV vaccine. Only through human clinical trials held to the highest scientific, ethical and regulatory standards will the goal of an HIV vaccine be realized.