FORT DETRICK, Md. – November 3, 2021 –
Trial aims to protect the warfighter against deadly infectious diseases
The U.S. Department of Defense (DOD) awarded Dynavax Technologies Corporation with an agreement worth approximately $22 million over two and a half years, to execute a clinical trial combining the DOD’s recombinant plague (rF1V) vaccine with its own CpG 1018® adjuvant. Under the agreement, Dynavax will conduct a Phase II clinical trial in 2022.
Plague is a potentially deadly infectious disease caused by bacteria found in fleas and rodents, or by handling a plague-infected animal. It is possible that pneumonic plague bacteria could be released intentionally in a biological attack to sicken people. Pneumonic plague is the most serious form and is the only one that spreads from person to person.
Dynavax’s planned Phase II randomized, placebo-controlled, observer-blind, multicenter clinical trial will evaluate the immunogenicity, safety, and tolerability of the U.S. government’s rF1V vaccine antigens, combined with Dynavax’s CpG 1018® adjuvant, in adults 18 to 55 years of age.
The clinical trial is funded by the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), with funding originating from the Chemical and Biological Defense Program. Any future clinical research or commercial supply agreements would be subject to a separate agreement between Dynavax and the U.S government.
“Enhancing the DOD’s rF1V vaccine is crucial for protecting service members across the globe, hopefully through fewer doses administered over a shorter time period,” said Dr. Jason Roos, Joint Program Executive Officer for the JPEO-CBRND. “In an environment of constantly evolving chemical, biological, radiological, and nuclear threats, our goal is to provide the means needed to expeditiously fight and win against future threats, so the warfighter can continue to carry out their mission.”
About the JPM CBRN Medical: The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability. To learn more about the JPM CBRN Medical, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.
About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.