Yersinia pestis (Y. pestis) bacteria is the causative agent of plague, typically transmitted from animals to humans by the bite of an infected flea. Y. pestis infection of the lungs leads to pneumonic plague, which is highly contagious and generally fatal. Y. pestis is a potential bioterrorist threat agent for which no vaccine yet exists.
This invention claims the generation and development of a candidate oral vaccine against plague. The vaccine consists of a synthetic gene construct that expresses a Y. pestis F1-V fusion antigen linked to a secretion signal, resulting in the production of large amounts of the F1-V antigen. The F1-V synthetic gene fusion is housed within Ty21a, an attenuated typhoid fever strain that is licensed for human use as a live oral bacterial vaccine. Ty21a serves as a carrier to deliver the F1-V fusion antigens of the plague bacteria; the combined F1-V fusion in the Ty21a carrier has been shown to stimulate a robust immune response in mice. The possibility of combining the oral plague vaccine of this invention with FDA’s candidate oral anthrax vaccine exists and would result in an easy-to-administer oral delivery system to streamline administration of the vaccine to large numbers of recipients in emergency situations.
Potential Commercial Applications:
- Plague vaccines, therapeutics and diagnostics.
- Vector is well-characterized.
- Simple manufacturing process.
- Potential low-cost vaccine.
US Application No. 61/650,676
US Application No. 14/402,457
PCT Application No. PCT/US13/42240
Bill Ronnenberg, JD-MIP, MS
FDA Technology Transfer Program
10903 New Hampshire Ave.
Building WO1, Rm 4214
Silver Spring, MD 20993
OTT Reference No: E-105-2011/0
Updated: August 4, 2015