Johnston M I, Noe J S, Killen J Y
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892.
AIDS Res Hum Retroviruses. 1994;10 Suppl 2:S317-23.
There is an urgent need for a prophylactic vaccine to protect individuals from AIDS and to help abate the growing epidemic. In October 1993, the Conference on Advances in AIDS Vaccine Development reviewed the state-of-the-art in vaccine research and confirmed both the progress that has been made and the challenges that remain. Approximately 12 candidate vaccines are now in phase I/II clinical trials. To date, these products appear to be safe and capable of eliciting immune responses in vaccinees. Other vaccine strategies in development include the use of new formulations and the design of vaccine products capable of inducing a mucosal immune response. Progress has also been made in the establishment of domestic and international sites at which efficacy trials can be conducted when appropriate vaccine candidates are identified, and preparatory activities at these sites are ongoing. The possibility that one or more candidates may enter efficacy trials within the next 2 years underscores numerous issues that must be considered in preparation for these trials. These include the importance of ease of vaccine administration and cost, and an array of social, legal, and ethical issues of concern to those individuals who will be asked to participate in efficacy trials. The purpose of this article is to highlight recent advances in vaccine research and development and to define the complex factors that will impact the NIAID's position on advancing candidates into phase III trials.
迫切需要一种预防性疫苗来保护个体免受艾滋病侵害，并帮助缓解日益蔓延的疫情。1993年10月，艾滋病疫苗开发进展会议审查了疫苗研究的最新状况，确认了已取得的进展和仍存在的挑战。目前约有12种候选疫苗正处于I/II期临床试验阶段。迄今为止，这些产品似乎是安全的，并且能够在接种疫苗者体内引发免疫反应。正在研发的其他疫苗策略包括使用新配方以及设计能够诱导黏膜免疫反应的疫苗产品。在确定合适的候选疫苗后可进行疗效试验的国内外场所的建立方面也取得了进展，这些场所的筹备工作正在进行。一种或多种候选疫苗可能在未来两年内进入疗效试验，这凸显了在为这些试验做准备时必须考虑的诸多问题。这些问题包括疫苗接种的简便性和成本的重要性，以及那些将被要求参与疗效试验的个体所关注的一系列社会、法律和伦理问题。本文的目的是强调疫苗研发的最新进展，并确定将影响美国国立过敏与传染病研究所（NIAID）关于推进候选疫苗进入III期试验立场的复杂因素。
