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EL SEGUNDO, Calif. -- Computer Sciences Corporation today announced that DVC LLC, a CSC company, has successfully vaccinated all volunteers in a phase 1 clinical trial for its recombinant plague vaccine candidate rF1V.
The trial is evaluating safety, tolerability and immunogenicity of the plague vaccine candidate in 44 healthy volunteers between the ages of 18 and 40. Long-term safety evaluation is underway and will be completed in early 2006 at the University of Kentucky Medical Center, Lexington, Ky. Safety monitoring, data collection and data management are being conducted by Covalent Group Inc. of Wayne, Pa. No vaccine-related serious adverse events have been reported to date.
"DVC was able to meet accelerated budget and schedule milestones for this program by integrating and managing the expertise of subcontractors that are leaders in their respective fields," said DVC chief scientific officer Dr. Robert V. House. "This is yet another example of how DVC delivers value and results to its customers."
The plague vaccine candidate is designed to provide protection against the plague bacterium Yersinia pestis, and was originally identified and developed by scientists working at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). Their work involved the identification of suitable protein antigens and the development of the processes used to assess the performance of the vaccine. Further development and manufacture of the vaccine candidate has been achieved by DVC under the Department of Defense Joint Vaccine Acquisition Program (JVAP) prime systems contract.
JVAP's mission is to develop, produce and stockpile FDA-licensed vaccine products to help protect the warfighter against biological warfare agents. JVAP consolidates the Department of Defense's efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines.
USAMRIID, located at Fort Detrick, Md., is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.
DVC is a biodefense company, dedicated to the development and licensure of safe and effective biological products. DVC is part of CSC's Enforcement, Security and Intelligence organization, which CSC created to support programs enhancing U.S. security.
The safety and efficacy of this product in humans has not yet been established. This product is currently under clinical investigation and has not been licensed by the FDA.
Source: Computer Sciences Corporation