LIVE ATTENUATED VACCINES FOR PANDEMIC PREPAREDNESS

大多数流感专家都认为，流感大流行即将到来。在大流行威胁下保护公众健康的一种潜在方法是大规模免疫接种。拟议的研究计划将评估开发、生产和分发减毒活疫苗的可行性，这种活疫苗最终可能在流感大流行期间进行人体试验。其目的将是检验这样一种假设，即在大流行威胁期间，使用基于大流行病毒毒株的减毒活疫苗接种是控制流感传播的一种可行和实用的方法。Aviron正在开发一种用于预防流感的普通减毒活疫苗，并有兴趣将这项技术应用于开发候选疫苗的大流行防范工作，以及建立相关能力，以确保广泛接种疫苗的可行性。具体而言，本研究项目将确定：利用经典重组技术产生含有禽流感病毒HA和NA基因和冷适应A/Ann Arbor/6/60病毒剩余基因的重组体的可行性；体外和动物模型重组基因的特性及安全性评价生产这种疫苗，包括确保适合人体试验的放行规程；候选疫苗在提供人类保护方面（在提供安全性和有效性方面）的有用性潜力；以及向大量人群快速、有效地分发和管理疫苗所需的方法。

Most influenza experts agree that we are "due" for an influenza pandemic. One potential method of protecting public health in the threat of a pandemic would be mass immunization. The research program being proposed will evaluate the feasibility of developing, manufacturing, and distributing a live attenuated vaccine which could ultimately be tested in humans for potential use during an influenza pandemic. The objective will be to test the hypothesis that vaccination with a live attenuated vaccine based on a pandemic virus strain is a feasible and practical way of controlling the spread of influenza during a threat of a pandemic. Aviron is developing a live attenuated vaccine for general use in the prevention of influenza, and is interested in applying this technology to pandemic preparedness efforts in developing a vaccine candidate, as well as building related competencies to ensure widespread vaccination is feasible. Specifically, this research program will determine: the feasibility of generating reassortants containing HA and NA genes derived from avian influenza virus and remaining genes from the cold-adapted A/Ann Arbor/6/60 virus using classic reassortment technique; the characterization and safety evaluation of the reassortants in vitro and in animal models; manufacturing such a vaccine including the release protocols to ensure appropriateness for human testing; the potential for usefulness (in providing safety and efficacy) of the vaccine candidate in providing protection in humans; and the methods required for rapid, efficient distribution and administration of the vaccine to large numbers of people.