MALARIA CVD 16000

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一种候选疟疾疫苗ICC-1132的开放标签、第一阶段、剂量递增的临床试验。因此，它旨在评估和比较成人肌肉注射疫苗的安全性、反应性和免疫原性。将招募18岁至45岁的健康成年人，并获得知情同意，并对每位志愿者进行仔细筛选，以确保其健康状况良好。共有48名志愿者被分成两个学习臂，将被招募。前16名符合条件的志愿者将被分配到10微克队列中，并随机分配接受生理盐水或ICC-1132+羟水凝胶的ICC-1132。第二个符合条件的16名志愿者将被分配到20微克队列中，并随机分配接受生理盐水或ICC-1132+羟水凝胶的ICC-1132。第三个符合条件的16名志愿者将被分配到50微克的队列中，并随机分配接受生理盐水或ICC-1132+羟水凝胶的ICC-1132。每个志愿者将在第0、56+4和168+14天接种分配的疫苗剂量的三次免疫。

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. This is an open label, phase I, dose-escalating clinical trial of a candidate malaria vaccine, ICC-1132. As such, it is designed to assess and compare the safety, reactogenicity, and immunogenicity of up to 3 intramuscular injections of the vaccine in adults. Healthy adults aged 18 to 45 years will be recruited, informed consent will be obtained, and each volunteer will be carefully screened to ensure that he or she is in good health. A total of 48 volunteers, divided into 2 study arms, will be enrolled. The first 16 eligible volunteers will be assigned to the 10 ug cohort and randomly assigned to receive ICC-1132 in saline or ICC-1132+alhydrogel. The second 16 eligible volunteers will be assigned to the 20 ug cohort and randomly assigned to receive ICC-1132 in saline or ICC-1132+alhydrogel. The third 16 eligible volunteers will be assigned to the 50 ug cohort and randomly assigned to receive ICC-1132 in saline or ICC-1132+alhydrogel. Three immunizations of the assigned vaccine dose will be administered to each volunteer on days 0,56+4,and 168+14.