Viral Evolution and Transmission Unit, IRCCS Ospedale San Raffaele, Milan, Italy
New Microbiol. 2022 Apr;45(2):99-103.
Since the beginning of the HIV/AIDS epidemy in the eighties, hundreds of phase I human immunization studies were performed, however, only nine tested efficacy in phase IIb/III clinical trials. While immunogens for SARS-CoV-2 did move along the development and clinical trial pipeline at unprecedent speed, two HIV immunization vaccine trials, started in 2016 and 2017, did meet non-efficacy criteria at the interim analysis and were thus, halted by the Data and Safety Monitoring Boards. The challenges in the quest to develop a safe, effective and durable HIV vaccine are unchanged. However, as research on HIV vaccine discovery moves forward there are many new tools and platform technologies to iterate vaccine strategies faster. Among these, there is a growing interest to conduct experimental medicine approaches where product development is directly informed by human data at an early stage of product development.
自八十年代艾滋病大流行开始以来,已经进行了数百项 I 期人体免疫研究,但只有 9 项在 IIb/III 期临床试验中测试了疗效。虽然用于 SARS-CoV-2 的免疫原沿着开发和临床试验管道以前所未有的速度前进,但两项于 2016 年和 2017 年开始的 HIV 免疫接种疫苗试验在中期分析时未达到疗效标准,因此被数据和安全监测委员会停止。开发安全、有效和持久的 HIV 疫苗的挑战仍然存在。然而,随着 HIV 疫苗发现研究的推进,有许多新的工具和平台技术可以更快地迭代疫苗策略。其中,人们越来越感兴趣地开展实验医学方法,在产品开发的早期阶段,直接根据人类数据来制定产品开发策略。