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.
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