Statistical evaluation of HIV vaccines in early clinical trials

被引:11
作者
Moodie, Z
Rossini, AJ
Hudgens, MG
Gilbert, PB
Self, SG
Russell, ND
机构
[1] Fred Hutchinson Canc Res Ctr, Stat Ctr HIV AIDS Res & Prevent, Seattle, WA 98109 USA
[2] Univ N Carolina, Dept Biostat, Chapel Hill, NC USA
[3] Fred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98109 USA
关键词
phase I/II clinical trials; HIV vaccine; trial design; power;
D O I
10.1016/j.cct.2005.11.008
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
The HIV pandemic is a pressing threat to global public health; HIV vaccine development is critical. Clinical evaluation of HIV vaccine candidates differs from the standard therapeutics trial framework primarily due to the fact that healthy individuals are studied. We present an early stage evaluation program developed for the HIV Vaccine Trials Network (HVTN) motivated by characteristics unique to the vaccine setting. The program consists of 3 prototypical stages (Phase I, Ib, II) that provide a unified yet flexible approach to the safety and immunogenicity evaluation of diverse vaccine regimens. The goal of these early trials is to narrow the number of candidate vaccines to the most promising candidates worthy of further study in efficacy trials. (c) 2005 Elsevier Inc. All rights reserved.
引用
收藏
页码:147 / 160
页数:14
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