The Center for Vaccine Development of the University of Maryland School of Medicine and the Center for Immunization Research in the Johns Hopkins Bloomberg School of Public Health comprise two of the world?s most experienced institutions in clinical trials and vaccine development. Through combined effort and collaboration, these two resources can interact synergistically to provide facilities and expertise necessary in a Clinical Trials Core to conduct clinical trials involving large numbers of subjects in an expedited fashion. We propose to create an infrastructure capable of meeting the requirements for accelerated clinical development of vaccines that could protect the population against the threat of bioterror. To this end, it is our intention to conduct RCE trials for vaccines, therapeutics and diagnostics at the two institutions in parallel, with each center providing half of the required number of volunteers. The academic, regulatory and administrative duties would be shared by alternating the assignment of Principal Investigator between the two institutions. The RCE plans to develop a large number of products that would require using clinical core testing facility. The overall goals of the clinical core are to provide facilities and personnel for the testing of vaccines, therapeutics and diagnostics in humans. In addition, the core will provide the experience and support services for IND preparation, protocol preparation and IRB submission as well as regulatory monitoring.