HIV VACCINE TRIALS NETWORK LEADERSHIP GROUP

HIV 疫苗试验网络领导小组

• 批准号: 7274620
• 负责人: STEVEN G. SELF
• 金额: $ 153.67万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-05-01 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7274620
• 关键词: AIDS; AIDS education /prevention; AIDS therapy; AIDS vaccines; HIV infections; clinical research; clinical trial phase I; cooperative study; data management; human immunodeficiency virus 1; human subject; human therapy evaluation; statistical service /center; vaccine development

EXCEED THE SPACE PROVIDED. This application to be the Statistical and Data Management Center (SDMC) for the proposed HIV Prevention Trials Network (HPTN) is submitted by the Fred Hutchinson Cancer Research Center (FHCRC) in response to the National Institute of Allergy and Infectious Disease (NIAID) RFA: AI-98-015, HPTN Leadership Group. The Universityof Washington, School of Public Health and Community Medicine, Department of Biostatistics will be a co-applicant and sub-contractor to the FHCRC. This SDMC application is one component of a three component application comprising the Leadership Group of the HIV Prevention Trials Network (HPTN). Separate applications describe the CORE applicant, Family Health International, Inc., Dr. Willard Gates Jr., PI, and the Central Laboratory applicant, Johns Hopkins University,Dr. Brooks Jackson, PI. The organization of the key scientific leadership components of this new network is shown in Section 1 and includesthe members of the Executive Committee, Prevention Leadership Group, External Advisory Committee, Scientific Working Groups and Protocol Review Committee. The CORE application contains a detailed description of how the HPTN proposes to carry out its scientific agenda. This application takes advantage of the particular strengths provided by both the FHCRC and UW. The FHCRC has several large statistical and data management coordinating centers for multi-site and multi-protocol clinical trial groups. The UW faculty has extensive biostatistical, epidemiological and clinical experience in research in HIV/AIDS and sexually transmitted diseases as well as considerable experience in conducting clinical trials. Drs. Self and Fleming have faculty appointments at both institutions (Dr. Self is Head of the Biostatistics Program at the FHCRC and Dr. Fleming serves as Chairman of the Department of Biostatistics at the UW), as do Drs. Huang and Richardson. With the strong ties that have existed between the two institutions since the FHCRC's establishment in 1972, virtually all FHCRC faculty and many UW faculty hold joint appointments, and thus, from an academic perspective, they can be regarded as the same institution. This application begins with a general background statement relating to the HIV epidemic and prevention efforts, bothunderway and proposed, to reduce the various modes of viral transmission. The balance of the application is specific to the SDMC which, in large measure, draws upon the experience of serving as the Statistical Center for the HIV Network for Prevention Trials (HIVNET) since 1994. The transition from HP/NET to HPTN will be described, as will the procedures andorganizational structures that will be carried forward into the HPTN and those that will be modified to enhance the objectives of the SDMC.

超出所提供的空间。 本申请将成为拟议的艾滋病毒预防试验网络的统计和数据管理中心（SDMC） （HPTN）是由弗雷德哈钦森癌症研究中心（FHCRC）提交的，以回应国家过敏研究所 和传染病（NIAID）RFA：AI-98-015，HPTN领导小组。华盛顿大学公共管理学院 卫生和社区医学，生物统计系将是FHCRC的共同申请人和分包商。 该SDMC应用程序是由艾滋病毒/艾滋病管理局领导小组组成的三个组件应用程序的一个组件。 预防试验网络。单独的申请描述了核心申请人，家庭健康国际公司，博士 小威拉德·盖茨，PI和约翰·霍普金斯大学中心实验室申请人，布鲁克斯·杰克逊博士，PI。本组织 这个新网络的关键科学领导组成部分在第1节中显示，包括执行委员会的成员 委员会、预防领导小组、外部咨询委员会、科学工作组和方案审查 以马克思CORE申请详细描述了HPTN如何建议执行其科学议程。 该应用程序利用了FHCRC和UW提供的特殊优势。FHCRC有几个大的 多中心和多方案临床试验组的统计和数据管理协调中心。华盛顿大学的教师们 在艾滋病毒/艾滋病和性传播疾病研究方面具有广泛的生物统计、流行病学和临床经验， 以及进行临床试验的丰富经验。赛尔夫博士和弗莱明博士在这两所大学都有教职 机构（Self博士是FHCRC生物统计学项目负责人，Fleming博士担任该部门主席 ），黄博士和理查森博士也是如此。由于两个机构之间存在着牢固的联系， 自1972年FHCRC成立以来，几乎所有的FHCRC教员和许多华盛顿大学教员都是联合任命的，因此， 从学术的角度来看，它们可以被视为同一个机构。 本申请以有关艾滋病毒流行和预防工作的一般背景陈述开始， 并建议减少各种病毒传播方式。应用程序的平衡是特定于SDMC的， 在很大程度上，它借鉴了作为艾滋病毒预防试验网络统计中心的经验 自1994年以来，将描述从HP/NET到HPTN的过渡，以及程序和组织 将被带入HPTN的结构，以及将被修改以增强SDMC目标的结构。

项目成果

Statistical evaluation of HIV vaccines in early clinical trials.

早期临床试验中艾滋病毒疫苗的统计评估。

• DOI: 10.1016/j.cct.2005.11.008
• 发表时间: 2006
• 期刊: Contemporary clinical trials.
• 作者: Moodie,Zoe;Rossini,AJ;Hudgens,MichaelG;Gilbert,PeterB;Self,StevenG;Russell,NinaD
• 通讯作者: Russell,NinaD

Identification of cross-neutralization determinants by GAP analysis: a mutational behavior approach.

通过 GAP 分析识别交叉中和决定因素：一种突变行为方法。

• DOI: 10.2174/157016207779316305
• 发表时间: 2007
• 期刊: Current HIV research
• 影响因子: 1
• 作者: Li,Fusheng;Gilbert,PeterB;Self,SteveG
• 通讯作者: Self,SteveG

Mapping HIV-1 vaccine induced T-cell responses: bias towards less-conserved regions and potential impact on vaccine efficacy in the Step study.

• DOI: 10.1371/journal.pone.0020479
• 发表时间: 2011
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Li F;Finnefrock AC;Dubey SA;Korber BT;Szinger J;Cole S;McElrath MJ;Shiver JW;Casimiro DR;Corey L;Self SG
• 通讯作者: Self SG

Estimating cumulative probabilities from incomplete longitudinal binary responses with application to HIV vaccine trials.

估计不完整纵向二元反应的累积概率并应用于艾滋病毒疫苗试验。

• DOI: 10.1002/sim.1334
• 发表时间: 2003
• 期刊: Statistics in medicine.
• 作者: Hudgens,MichaelG