CSC (NYSE: CSC) announced that DynPort Vaccine Company LLC (DVC), a CSC company, has initiated a Phase 2b clinical trial for its Yersinia pestis Plague Recombinant Vaccine (rF1V) candidate, which is designed to provide protection against the plague bacterium Y. pestis in aerosolized form. The trial will evaluate the safety and immunogenicity of rF1V produced at large scale, assess the requirement for adjuvant in rF1V vaccine, and compare the safety and immunogenicity of two administration schedules for the vaccine candidate in 400 healthy volunteers. The U.S. Department of Defense is funding DVC's development of the plague vaccine candidate up to and including possible licensure by the U.S. Food and Drug Administration.

"Working closely with our client and subcontractors, DVC has made tremendous progress toward a licensed plague vaccine in support of the U.S. government's biodefense initiatives," said Dr. Robert V. House, president of DVC.

Phase 1 and 2a, which are completed, evaluated the vaccine in more than 400 healthy volunteers. Safety and immunogenicity data supported further clinical evaluation of the vaccine candidate. In addition to clinical trials, nonclinical testing required to support licensure of rF1V under the FDA Animal Rule is ongoing. Clinical trials are managed by DVC at its headquarters in Frederick, Md., and conducted through various clinical research organizations.

The vaccine was originally identified and developed by scientists working at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). DVC has further developed and manufactured the vaccine under the DoD Chemical Biological Medical Systems Joint Vaccine Acquisition Program (CBMS-JVAP) contract. DVC has served as prime systems contractor for CBMS-JVAP since 1997.

The safety and efficacy of this product in humans has not been established. The product is currently under clinical investigation and has not been licensed by the FDA.

Source:
DynPort Vaccine Company LLC (DVC)
CSC