CSC's DynPort Edges One Step Closer to Plague Vaccine
Client:Department of Defense Chemical Biological Medical Systems-Joint Vaccine Acquisition Program (DoD CBMS-JVAP)
- The causative agent of plague, Yersinia pestis, is naturally occurring and widely available. Due to its availability and relative ease of aerosolization, plague is classified as a Category A biological threat agent.
- There is currently no licensed plague vaccine.
- Working with the DoD, USAMRIID and expert subcontractors, DynPort is managing advanced development of a recombinant plague vaccine (rBV A/B).
- DynPort is working toward licensure of a biodefense vaccine that can protect defense personnel and the civilian population in the event of an attack using Y. pestis in aerosol form.
- The vaccine candidate is currently in Phase 2b clinical trials.
It's lethal. It's extremely contagious. Plague is caused by the Gram-negative bacterium Yersinia pestis and is one of the oldest documented infectious diseases. Infections are classified as either bubonic or pneumonic plague depending on the route of transmission (flea bite or aerosol, respectively). Three pandemics of plague have occurred in recorded history, each resulting in enormous morbidity and mortality.
Pneumonic Plague: A Terrifying Biological Weapon
As the Working Group on Civilian Biodefense wrote, "The availability of Y. pestis around the globe, the capacity for its mass production and aerosol dissemination ... make the use of plague as a biological weapon a great concern." Aerosol exposure leads to sepsis and death much more rapidly than bubonic plague. Within 72 hours of exposure, 100% of pneumonic plague exposures result in death if untreated. Antibiotic therapy is effective only when administered within 18 hours of exposure. If treatment starts at the first sign of disease, it is generally too late for successful intervention
DynPort's Goal: A Vaccine to Combat the Terror
DynPort Vaccine Company LLC, on behalf of the Department of Defense Chemical Biological Medical Systems-Joint Vaccine Acquisition Program (DoD CBMS-JVAP), is developing a recombinant plague vaccine designed to provide protection against pneumonic plague. Thanks to the dedication and skills of a team of scientists at CSC's DynPort, in close partnership with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), and an expert team of subcontractors, the world is one step closer to a pneumonic plague vaccine
In April 2004, DynPort announced that it had completed nonclinical testing of its plague vaccine — conceived and developed at USAMRIID, then handed over to DynPort for advanced development, testing and licensure. In initial testing, the vaccine protected mice against both bubonic and pneumonic plague.
Explains Technical Development Manager Lawrence Wolfraim, Ph.D, "Previous vaccines against plague used killed whole Y. pestis organisms and were effective at preventing bubonic plague, the form of the disease naturally transmitted by fleas. These vaccines were also more reactogenic, with vaccinated individuals frequently developing adverse reactions. However, these vaccines were not protective against pneumonic plague, which is much more deadly.
"Weaponized plague organisms would likely be deployed as aerosols, leading to the more deadly pneumonic form of the disease. Therefore, from a biodefense perspective, there is a real need for a vaccine that can prevent pneumonic plague. Our goal is to develop and license a safer recombinant vaccine that protects the warfighter and civilian population against pneumonic plague, in the event of a bioterrorism attack where aerosolized Y. pestis is deployed."
Clinical Trials Began in 2005
Following successful nonclinical efficacy and safety studies, DVC began the next step — human clinical trials of the vaccine. DynPort reported final results of the Phase 1 clinical trials in 2007 and the Phase 2a trial in 2008 to the U.S. Food and Drug Administration (FDA). A Phase 2b clinical trial was initiated in August 2010. The vaccine program has received Fast Track designation and DynPort plans to seek approval using the FDA Animal Efficacy Rule.
The plague vaccine candidate is one of a range of biodefense vaccines being developed by DynPort under its contract with the DoD. Currently, there is no FDA-licensed plague vaccine.
The safety and efficacy of this product in humans has not been established. This product is currently under clinical investigation and has not been licensed by the FDA. This program is funded by Department of Defense Contract DAMD17-98-C-8024.
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