Richert Laura, Lhomme Edouard, Fagard Catherine, Lévy Yves, Chêne Geneviève, Thiébaut Rodolphe
a University of Bordeaux, ISPED ; Bordeaux , France.
Hum Vaccin Immunother. 2015;11(4):1022-9. doi: 10.1080/21645515.2015.1011974.
HIV vaccine strategies are expected to be a crucial component for controlling the HIV epidemic. Despite the large spectrum of potential candidate vaccines for both prophylactic and therapeutic use, the overall development process of an efficacious HIV vaccine strategy is lengthy. The design of clinical trials and the progression of a candidate strategy through the different clinical development stages remain methodologically challenging, mainly due to the lack of validated correlates of protection. In this review, we describe recent advances in clinical trial designs to increase the efficiency of the clinical development of candidate HIV vaccine strategies. The methodological aspects of the designs for early- (phase I and II) and later -stage (phase IIB and III) development are discussed, taking into account the specificities of both prophylactic and therapeutic HIV vaccine development.
HIV疫苗策略有望成为控制HIV流行的关键组成部分。尽管有大量潜在的预防性和治疗性候选疫苗，但有效的HIV疫苗策略的整体开发过程漫长。临床试验的设计以及候选策略在不同临床开发阶段的推进在方法上仍具有挑战性，主要原因是缺乏经过验证的保护相关性指标。在本综述中，我们描述了临床试验设计方面的最新进展，以提高候选HIV疫苗策略临床开发的效率。同时讨论了早期（I期和II期）和后期（IIB期和III期）开发设计的方法学方面，同时考虑到预防性和治疗性HIV疫苗开发的特殊性。
