Development of a plant-grown subunit vaccine against respiratory syncytial virus

描述（由申请方提供）：呼吸道合胞病毒（RSV）引起的疾病是全球范围内的重大医疗保健负担。RSV几乎感染了全世界发达国家和发展中国家的所有儿童。再次感染是常见的，因为自然感染不会诱导持久的免疫力。此外，严重的RSV感染越来越多地发生在老年人中。尽管大规模的努力，以生产一种有效的疫苗，针对RSV，没有疫苗是尚未获得。 开发廉价的可食用植物基口服疫苗是控制RSV的创新方法。本研究首次将使用植物性口服疫苗的策略扩展到呼吸道病原体。即使用植物疫苗不能获得持久的免疫力，在连续的RSV季节中使用这种疫苗的成本也相对较低。 我们先前已经表明，用表达RSV亚单位蛋白的转基因番茄果实口服免疫小鼠，F蛋白，诱导全身免疫反应。该“原理证明”I期研究将优化转基因番茄果实中RSV-F蛋白的表达，并确定该口服给予的抗原蛋白在RSV研究的两种常用模型Balb/c小鼠和棉鼠中保护免受RSV攻击的能力。成功将验证我们针对RSV的番茄疫苗的进一步开发，并为II期研究奠定基础。这种疫苗肯定会有所作为，并对人类健康产生持久的影响。 公共卫生相关性：呼吸道合胞病毒引起的疾病是世界范围内的重大卫生保健负担，但没有疫苗可用。我们正在开发一种廉价的疫苗，使用番茄植物来控制这种病毒。

DESCRIPTION (provided by applicant): Respiratory syncytial virus (RSV)-caused disease represents a significant health care burden worldwide. The RSV infects virtually all children throughout the world in both developed and developing countries. Re-infection is common because natural infection does not induce lasting immunity. Also, severe RSV infections are increasingly occurring among the elderly. In spite of wide-scale efforts to produce an effective vaccine against RSV, no vaccine is yet available. Development of an inexpensive edible plant-based oral vaccine is an innovative approach for the control of RSV. The present study extends the strategy of using a plant-based oral vaccine to a respiratory pathogen for the first time. Even if lasting immunity is not obtained with the plant-based vaccine, it would be relatively low in cost to use such a vaccine during successive RSV seasons. We have shown previously that oral immunization of mice with transgenic tomato fruit expressing an RSV- subunit protein, i.e., the F-protein, induces a systemic immune response. This "proof of principle" Phase I study will optimize the expression of the RSV-F protein in the transgenic tomato fruit and determine the capacity of this orally-given antigenic protein to protect against an RSV challenge in two commonly-used models for RSV studies, the Balb/c mouse and the cotton rat. Success will validate the further development of our tomato- based vaccine against RSV and set the stage for a Phase II study. Such a vaccine will definitely make a difference and have an enduring impact on human health. PUBLIC HEALTH RELEVANCE: Respiratory syncytial virus-caused disease is a significant health care burden worldwide, but no vaccine is available. We are developing an inexpensive vaccine using tomato plants to control this virus.