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Plague - Research - Development of a Recombinant Vaccine

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¹ DynPort Vaccine Company LLC (DVC), A  CSC Company, 64 Thomas Johnson Drive, Frederick, MD 21702, USA.

Abstract. Although few diseases have had a greater impact on human history, currently there is no vaccine available for protection against plague that is licensed by the Food and Drug Administration (FDA). DVC is managing advanced development of a recombinant plague vaccine (rF1V) for the U.S. Department of Defense that will provide protection against plague aerosols, the most likely form a biological weapon would take.

The vaccine was originally developed at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). To meet the requirements for licensure in the shortest possible time, DVC developed a strategy for the integration of data from USAMRIID with data from clinical and nonclinical studies conducted by DVC.

This strategy is based on parallel development and validation of assays for analysis of animal and human immune responses to the vaccine that facilitated the transfer of the candidate from the developing lab at USAMRIID. These assays also form the foundation of our approach to the licensure of the rF1V vaccine using the FDA Animal Rule.

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