Excler J L, Parks C L, Ackland J, Rees H, Gust I D, Koff W C
International AIDS Vaccine Initiative, 110 William Street, 27th Floor, New York, NY 10038-3901, USA.
Biologicals. 2010 Jul;38(4):511-21. doi: 10.1016/j.biologicals.2010.03.005.
In October 2009, The International AIDS Vaccine Initiative (IAVI) convened a satellite symposium entitled 'Replicating Viral Vectors for use in AIDS Vaccines' at the AIDS Vaccine 2009 Conference in Paris. The purpose of the symposium was to gather together researchers, representatives from regulatory agencies, and vaccine developers to discuss issues related to advancement of replication-competent viral vector- based HIV vaccines into clinical trials. The meeting introduced the rationale for accelerating the development of replicating viral vectors for use as AIDS vaccines. It noted that the EMEA recently published draft guidelines that are an important first step in providing guidance for advancing live viral vectors into clinical development. Presentations included case studies and development challenges for viral vector-based vaccine candidates. These product development challenges included cell substrates used for vaccine manufacturing, the testing needed to assess vaccine safety, conducting clinical trials with live vectors, and assessment of vaccination risk versus benefit. More in depth discussion of risk and benefit highlighted the fact that AIDS vaccine efficacy trials must be conducted in the developing world where HIV incidence is greatest and how inequities in global health dramatically influence the political and social environment in developing countries.
2009年10月，国际艾滋病疫苗倡议组织（IAVI）在巴黎召开的2009年艾滋病疫苗大会上举办了一场题为“用于艾滋病疫苗的复制型病毒载体”的卫星研讨会。该研讨会的目的是召集研究人员、监管机构代表和疫苗开发者，讨论与具有复制能力的基于病毒载体的HIV疫苗推进到临床试验相关的问题。会议介绍了加速开发用作艾滋病疫苗的复制型病毒载体的基本原理。会议指出，欧洲药品管理局（EMEA）最近发布了指导方针草案，这是为推进活病毒载体进入临床开发提供指导的重要第一步。发言内容包括基于病毒载体的候选疫苗的案例研究和开发挑战。这些产品开发挑战包括用于疫苗生产的细胞基质、评估疫苗安全性所需的测试、进行活载体的临床试验以及评估接种风险与益处。对风险和益处的更深入讨论突出了这样一个事实，即艾滋病疫苗疗效试验必须在HIV发病率最高的发展中国家进行，以及全球卫生方面的不平等如何极大地影响发展中国家的政治和社会环境。
