SDMC: HIV Vaccine Trials Network

描述（由申请人提供）：本申请继续作为 HIV 疫苗试验网络 (HVTN) 的统计和数据管理中心 (SDMC)，是组成 HVTN 领导小组的三份申请之一。为了实现 RFA-AI-12-012 中描述的总体科学目标，即开发安全有效的 HIV 疫苗，HVTN SDMC 科学议程包括以下目标： 目标 1，提供高质量的安全数据管理和安全监测，并通过应用最佳数据和临床管理实践、遵守临床数据交换标准和实施最先进的技术来不断提高质量和效率；目标 2，设计、监测和分析疗效前试验，评估候选 HIV 疫苗方案的安全性和免疫原性；目标 3，开发和实施用于测量疫苗的免疫测定的数据处理和分析的工具和方法 免疫原性；目标 4，完善和实施新型 2b 期概念测试和 3 期许可试验设计，主要目标是评估疫苗预防 HIV 感染的功效； 目标 5，完善和实施新的定量方法，用于评估和开发 HIV 感染保护的免疫相关性以及疾病进展的早期生物标志物，以显示疗效的治疗方案；目标 6，与其他 NIAD 网络合作，考虑非疫苗预防方式以实现目标 2 至 5 的目标，并共同进行联合治疗方案试验；目标 7，进行临床试验以评估用于 HIV 免疫预防的单克隆抗体以及用于 TB 和 HCV 的疫苗。 SDMC 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、监控和分析的系统经过充分测试，符合 GCDMP、21 CFR 第 11 部分和 GCP，并且符合 CDISC 标准。此外，SDMC 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 HIV 疫苗试验计划的效率、严谨性和科学敏锐度。 相关性：据估计，全球有 3400 万人感染艾滋病毒，每年新增感染者 270 万人（2011 年联合国艾滋病规划署）。尽管生物医学干预措施最近取得了降低艾滋病毒感染风险的进展，但消除这一流行病仍需要安全有效的方法 艾滋病毒疫苗。只有通过遵循最高科学、伦理和监管标准的人体临床试验，才能实现艾滋病毒疫苗的目标。

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.