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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 正在研究LC 16 m8疫苗是否可能在美国（US）获得许可，作为目前获得许可的Dryvax牛痘疫苗的潜在更安全的替代品，用于预防天花、牛痘和相关正痘病毒。 斯坦福大学将招募45名健康的疫苗初治志愿者，年龄范围为18-33岁，符合筛选和入选/排除标准。 志愿者将被随机分为2组：四分之三接受LC 16 m8的个体和四分之一接受Dryvax牛痘菌株的个体。 该研究的目标是： 在未接种过疫苗的健康志愿者中评估接种LC 16 m8疫苗或Dryvax疫苗后的安全性、临床应答和免疫原性。

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.