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。 开发安全、有效的预防天花疫苗是国家生物防御准备的重要组成部分。具体目的是：1)建立Imvamune疫苗与安慰剂和Dryvax相比的安全性和临床副作用概况。2)了解疫苗激活以产生免疫反应的免疫系统的不同组成部分。3)了解接受不同剂量Imvamune和/或Dryvax的个人的保护时间，以用于最终制定生物防御的事后建议。 2007年7月，应CBER的要求，暂停招生。该协议已修改如下。195名受试者将被随机分配到三组中的一组，分别在A和B组皮下接种两次Imvamune疫苗或安慰剂，或在F组皮下接种一次Imvamune疫苗或安慰剂。(注：共有195名受试者被随机分配到A、B和F组，因为B组中有两名受试者已登记在册。)这些人将在接种疫苗后的一个月内，以及在接种第一剂疫苗后的6个月和12个月内经常来进行后续访问。他们将被要求保留副作用日记，并将进行实验室研究，以评估安全性、毒性和免疫反应。一种具有更好的安全性和免疫原性的替代天花疫苗对国家提供战略性生物防御的能力非常重要。

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.