A PHASE I/II OF LC16M8, A MODIFIED VACCINIA VACCINE IN HEALTHY VOLUNTEERS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 美国正在研究LC16m8疫苗的许可可能性，作为目前获得许可的Dryvax痘苗的潜在更安全的替代品，用于预防天花、牛痘和相关的正痘病毒。斯坦福大学将招募45名健康的疫苗初学者志愿者，年龄从18岁到33岁不等，他们符合筛查和纳入/排除标准。志愿者将被随机分成两组：四分之三的人接种LC16m8疫苗，四分之一的人接种Dryvax疫苗株。 这项研究的目标是： 健康接种初治志愿者接种LC16m8疫苗或Dryvax疫苗后的安全性、临床反应和免疫原性评估。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. LC16m8 vaccine is being studied for possible licensure in the United States (US) as a potentially safer alternative to the currently licensed Dryvax vaccinia vaccine for protection against smallpox, vaccinia, and related Orthopoxviruses. A total of 45 healthy vaccinia-naive volunteers will be enrolled at Stanford, ranging in age from 18-33 years-old and who fulfill the screening and inclusion/exclusion criteria. Volunteers will be randomized into 2 groups: three fourths of the individuals receiving LC16m8 and one fourth of the individuals receiving the Dryvax strain of vaccinia. The objectives of the study will be the: Assessment of safety, clinical responses, and immunogenicity following vaccination with the LC16m8 vaccine or Dryvax vaccine in healthy vaccinia-naive volunteers.