EL SEGUNDO, Calif., Nov. 18 /PRNewswire/ -- 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., , 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.
About Covalent Group, Inc.
Covalent Group, Inc. is a clinical research organization that is a leader in the design and management of complex clinical trials and Patient Disease Registries for the pharmaceutical, biotechnology and medical device industries. The Company's mission is to provide its clients with high quality, full-service support for their clinical trials. Covalent offers therapeutic expertise, experienced team management and advanced technologies. The Company has clinical trial experience across a wide variety of therapeutic areas such as cardiovascular, endocrinology/metabolism, diabetes, vaccines, biologics, gene therapy, immunology, neurology, oncology, infectious diseases, gastroenterology, dermatology, hepatology, womens' health and respiratory medicine. Covalent believes that its leadership in the design of complex clinical trials, its application of innovative technologies, therapeutic expertise and commitment to quality offer its clients a means to more quickly and cost effectively develop products through the clinical trial process. With its wholly-owned international subsidiary, Covalent Group, Ltd., as well as its Strategic Partners operating in various regions around the world, Covalent is able to meet the global drug development needs of its clients. For more information, please visit www.covalentgroup.com.
Founded in 1959, Computer Sciences Corporation is a leading global information technology (IT) services company. CSC's mission is to provide customers in industry and government with solutions crafted to meet their specific challenges and enable them to profit from the advanced use of technology.
With approximately 78,000 employees, CSC provides innovative solutions for customers around the world by applying leading technologies and CSC's own advanced capabilities. These include systems design and integration; IT and business process outsourcing; applications software development; Web and application hosting; and management consulting. Headquartered in El Segundo, Calif., CSC reported revenue of $14.5 billion for the 12 months ended Sept. 30, 2005. For more information, visit the company's Web site at www.csc.com.
Computer Sciences Corporation
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