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本文引用的文献

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Evaluating neutralizing antibodies against HIV, SIV, and SHIV in luciferase reporter gene assays.在荧光素酶报告基因检测中评估针对HIV、SIV和SHIV的中和抗体。
Curr Protoc Immunol. 2005 Jan;Chapter 12:12.11.1-12.11.17. doi: 10.1002/0471142735.im1211s64.
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Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand.泰国曼谷注射吸毒者中一种二价重组糖蛋白120 HIV-1疫苗的随机、双盲、安慰剂对照疗效试验。
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Correlation between immunologic responses to a recombinant glycoprotein 120 vaccine and incidence of HIV-1 infection in a phase 3 HIV-1 preventive vaccine trial.在一项3期HIV-1预防性疫苗试验中，重组糖蛋白120疫苗的免疫反应与HIV-1感染发生率之间的相关性。
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Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection.一项用于预防HIV-1感染的重组糖蛋白120疫苗的安慰剂对照3期试验。
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Sample size estimation for GEE method for comparing slopes in repeated measurements data.用于比较重复测量数据中斜率的广义估计方程（GEE）方法的样本量估计
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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.

DOI:10.1198/sbr.2009.0008
PMID:20072667
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2805400/
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。