同时评估左右删失多变量响应的幅度和广度，并应用于HIV疫苗开发。
Simultaneous Evaluation of the Magnitude and Breadth of a Left and Right Censored Multivariate Response, with Application to HIV Vaccine Development.
作者信息
Huang Yunda, Gilbert Peter B, Montefiori David C, Self Steve G
机构信息
Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington.
出版信息
Stat Biopharm Res. 2009 Feb 1;1(1):81-91. doi: 10.1198/sbr.2009.0008.
Abstract
Both the magnitude and breadth of neutralization against multiple strains of virus are main endpoints for comparing antibody-based HIV-1 vaccine candidates in Phase I and II trials, and are key markers to be evaluated in vaccine efficacy trials as immune correlates of protection against HIV-1 infection. More generally, consideration of both magnitude and breadth is encountered when there is interest in comparing quantitative multivariate response data between groups. In this paper, we discuss two approaches to simultaneously evaluating the magnitude and breadth of a multivariate response. We suggest methods for the summarization and group comparison of multivariate response data that are subject to left and/or right censoring. Applications to data from a phase III clinical trial (Vax004) are discussed. Simulation-based sample size calculations and power analyses of the described methods also are presented.
摘要
针对多种病毒株的中和作用的强度和广度，是在I期和II期试验中比较基于抗体的HIV-1疫苗候选物的主要终点，并且是在疫苗效力试验中作为预防HIV-1感染的免疫相关指标进行评估的关键标志物。更一般地说，当有兴趣比较组间定量多变量反应数据时，会同时考虑强度和广度。在本文中，我们讨论了两种同时评估多变量反应的强度和广度的方法。我们提出了适用于左删失和/或右删失的多变量反应数据的汇总和组间比较方法。讨论了这些方法在一项III期临床试验（Vax004）数据中的应用。还给出了基于模拟的样本量计算以及所描述方法的功效分析。
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