EVALUATION OF IMVAMUNER SMALLPOX VACCINE WITH RESPECT TO SAFETY AND OPTIMIZATION

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。子项目和 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。 开发安全、有效的天花疫苗是国家生物防御准备工作的重要组成部分。具体目的是1）确定Imvamune疫苗与安慰剂和Dryvax相比的安全性和临床副作用特征。2)了解疫苗激活免疫系统以产生免疫反应的不同组成部分。3)了解不同剂量的Imvamune和/或Dryvax对个体的保护时间，以用于最终制定生物防御的事后建议。 2007年7月，在CBER的要求下，招募停止。方案修改如下。将195例受试者随机分配至三组之一，A组和B组接受两次IMVAMUNE <$疫苗或安慰剂皮下免疫，F组接受IMVAMUNE <$或安慰剂皮下单次免疫。(NOTE：共197例受试者将随机分配至A、B和F组，因为2例受试者之前入组B组。） 这些人将在接种疫苗后的一个月内经常进行随访，然后在接种第一剂疫苗后6个月和12个月进行随访。 他们将被要求保持副作用日记，并将进行实验室研究，以评估安全性，毒性和免疫反应。 一种具有改进的安全性和免疫原性的替代天花疫苗对国家战略性地提供生物防御的能力很重要。

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. Development of safe, effective vaccines for protection against smallpox is an important component of national readiness in biodefense. The specific aims are to 1) establish the safety and clinical side effect profile of Imvamune Vaccine as compared to placebo and to Dryvax. 2) Understand the different components of the immune system that the vaccine activates to develop an immune response. 3) Understand the timing of protection in individuals receiving Imvamune in different doses and /or Dryvax for use in eventual development of recommendations in a post-event scenario for biodefense. In July, 2007, enrollment was halted at the request of CBER. The protocol has been modified as follows. One hundred and ninety-five subjects will be randomly assigned to one of three groups to be immunized twice with IMVAMUNE¿ vaccine or placebo subcutaneously in Groups A and B, or to receive a single immunization with IMVAMUNE¿ or placebo subcutaneously in Group F. (NOTE: A total of 197 subjects will be randomly assigned to Groups A, B, and F as two subjects were previously enrolled in Group B.) These individuals will come for follow up visits frequently in the month following vaccine, and then 6 and 12 months after receiving the first dose of vaccine. They will be asked to maintain a diary of side effects and will have lab studies done to evaluate for safety, toxicity and immune response. An alternative smallpox vaccine with an improved safety profile and immunogenicity profile is important to the nation's ability to strategically provide biodefense.