Clinical studies of experimental vaccines
Clinical studies of experimental vaccines
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DOI：
10.1097/01.coh.0000232343.23533.70
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发表时间：
2006-07-01
影响因子：
4.1
通讯作者：
Pantaleo, Giuseppe
中科院分区：
文献类型：
--
作者：
Bart, Pierre-Alexandre;Harari, Alexandre;Pantaleo, Giuseppe
综述的目的是提供HIV疫苗临床发展的现状。还将讨论一系列问题，如正在研制的候选疫苗所激发的免疫反应的类型，保护的免疫相关性的进展，选择候选疫苗用于进一步临床开发的有效决策过程的必要性，以及临床试验的原理。最近的发现到目前为止，在开发诱导广泛中和抗体的艾滋病毒疫苗方面取得的进展都是失败的。目前的研发流程主要由候选疫苗组成，旨在诱导细胞免疫，特别是T细胞反应。基于这些原因，这些候选疫苗被称为“T细胞疫苗”。2005年，大量候选疫苗或疫苗组合进入了I-II期临床试验。此外，一种基于腺病毒载体的疫苗已经进入概念验证疗效试验，一种金丝雀痘载体与一种基于蛋白质的疫苗的组合目前正在进行第三阶段临床试验。T细胞疫苗已被证明是安全的，最新一代的T细胞疫苗也具有实质性的免疫原性。概述只有临床试验才能对免疫保护和疫苗效力的相关性提供明确的答案。
Purpose of reviewThe scope of this review is to provide the current status of HIV vaccine clinical development. A series of issues regarding the type of immune response stimulated by the candidate vaccines in the pipeline, the advances in the immune correlates of protection, the need for an effective decision-making process for selection of candidate vaccines into further clinical development and the rationale for clinical trials will also be discussed.Recent findingsEfforts in the development of HIV vaccines inducing broad neutralizing antibodies have failed so far. The current pipeline is predominantly composed of candidate vaccines designed to induce cellular immunity and particularly T-cell response. For these reasons, these candidate vaccines have been termed 'T-cell vaccines'. A large number of candidate vaccines or vaccine combinations have entered phase I-II clinical trials in 2005. Furthermore, an adenovirus vector-based vaccine has entered proof-of-concept efficacy trial and a canarypox vector in combination with a protein-based vaccine is currently being evaluated in phase III clinical trials. T-cell vaccines have been shown to be safe and the most recent generation of these vaccines also has substantial immunogenicity.SummaryOnly clinical trials can provide the definitive answer to immune correlates of protection and vaccine efficacy.