A joint, multi-nation project arrangement between the U.S. Department of Defense (DoD), the Department of National Defence of Canada, and the Secretary of State for Defense of the United Kingdom of Great Britain and Northern Ireland was announced today for the cooperative development of a vaccine to protect against plague. Under this agreement, the three nations will work together to develop and produce a plague vaccine that will ultimately be licensed for human use.
The defense establishments of the United States and the U.K. have each maintained active plague vaccine research and development efforts since the 1990s. Relevant plague vaccine development information has been shared among the U.S., U.K., and Canada under provisions of a memorandum of understanding between the three nations since 2000.
The U.K. plague vaccine candidate is a purified subunit vaccine containing the F1 and V antigens purified separately from recombinant Escherichia coli and then mixed together, while the DoD vaccine candidate contains the F1 and V antigens linked together as a fusion protein. The F1V fusion protein candidate was pioneered by the U.S. Army Medical Research Institute of Infectious Diseases, of the U.S. Army Medical Research and Materiel Command. The DoD program is now managed by the Joint Vaccine Acquisition Program in the office of the Joint Program Executive Office for Chemical and Biological Defense.
Testing of the U.K. plague vaccine candidate in the United States under the joint project arrangement is expected to begin in late 2005 with a phase one clinical trial to be performed in accordance with regulations administered by the Food and Drug Administration (FDA). The DoD plague vaccine candidate began phase one clinical trials, at the University of Kentucky, in the first quarter of 2005. This joint effort will continue until late 2005, at which time the DoD will evaluate both vaccine candidates and select one for continued advanced development.