DEVELOPMENT OF A LIVE ATTENUATED HSV-2 VACCINE

描述：(改编自申请者摘要)生殖器疱疹是一种 美国的健康问题。这些感染的流行是戏剧性的 尽管有有效的抗病毒药物，但发病率仍在上升。这一增长使年轻人 以及分别有生殖器疱疹和新生儿疱疹风险的婴儿。新生儿 疱疹感染与神经损伤和高死亡率有关。 此外，活跃的生殖器疱疹病变有助于艾滋病毒的传播。 大部分传播是由于无症状的脱落，这突出了 需要一种有效的预防性疫苗来减少生殖器传播 因此，减少新生儿疱疹的发病率。最近的一个研究所 医学部关于21世纪疫苗优先事项的报告强调了 一种安全有效的生殖器疱疹疫苗。Aviron建议开发 预防HSV-2疾病的减毒活疫苗。一个活生生的，衰减的， 重组单纯疱疹病毒2型病毒除缺乏两个拷贝的Gamma1 34.5基因外 构建了UL55、UL56和US10-US12。这个重组体是高度 神经衰弱，遗传稳定。在这项提议期间，该病毒将 在豚鼠生殖器疱疹模型中评价其安全性和有效性。在……里面 此外，进一步的体外鉴定将使高质量的临床 将为IND支持灵长类研究和早期阶段制作试验材料 我做人体试验。 建议的商业应用： 不可用

DESCRIPTION: (Adapted from Applicant's Abstract) Genital herpes is a major health problem in the U.S. The prevalence of these infections is dramatically increasing despite effective antiviral drugs. This increase puts young adults and infants at risk of genital and neonatal herpes, respectively. Neonatal herpes infections are associated with neurologic impairment and high mortality. In addition, active genital herpes lesions facilitate the transmission of HIV. Much of the transmission is due to asymptomatic shedding which highlights the need for an efficacious prophylactic vaccine to reduce the spread of genital herpes and thereby reduce the incidence of neonatal herpes. A recent Institute of Medicine report on vaccine priorities for 21st century highlights the need for a safe and effective vaccine for genital herpes. Aviron proposes to develop a live attenuated vaccine to prevent HSV-2 disease. A live, attenuated, recombinant HSV-2 virus lacking both copies of gamma1 34.5 gene in addition to UL55, UL56, and US10-US12 was constructed. This recombinant was highly neuroattenuated and genetically stable. During this proposal this virus will be evaluated in the guinea pig model of genital herpes for safety and efficacy. In addition further in vitro characterization will enable high quality clinical trial material to be produced for IND enabling primate studies and early Phase I human trials. PROPOSED COMMERCIAL APPLICATION: Not Available