Dynavax has executed an agreement for around $22m over two and a half years to develop the recombinant vaccine.
The randomized, placebo-controlled, observer-blind, multicenter clinical trial will evaluate the immunogenicity, safety, and tolerability of the rF1V vaccine antigens provided by the US government combined with Dynavax's CpG 1018 adjuvant in adults 18 to 55 years of age. The trial is expected to begin in 2022.
The award, funded by the 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), will also enable Dynavax to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).
Well-known for widespread pandemics throughout history and in particular the middle ages, plague is a potentially deadly infectious disease caused by bacteria found in fleas and rodents or infected animals. It is caused by the bacterium, Yersinia pestis. Pneumonic plague bacteria has been identified by US authorities as an agent of concern for potential intentional release in a biological attack.
COL Ryan Eckmeier, the Joint Project Manager for CBRN Medical, commented, "Advancing the development of a recombinant plague vaccine supports the JPM CBRN Medical's vision to deliver a full, layered medical countermeasure capability to enable a protected and unencumbered Joint Force to fight and win in any global CBRN battlespace. Incorporating the CpG 1018 adjuvant to the DOD's rF1V vaccine will hopefully allow us to protect our service members with fewer doses administered over a shorter time period."
Meanwhile, the disease can still be found in certain areas of the world. Most human cases since the 1990s have occurred in Africa. A 2017 epidemic in Madagascar resulted in 171 deaths.
The rF1V vaccine was originally developed at the US Army Medical Research Institute for Infectious Diseases.
CpG 1018 adjuvant
CpG 1018 is used in Dynavax’ FDA-licensed adult hepatitis B vaccine, Heplisav-B; while several late-stage COVID-19 vaccine candidates are also using the adjuvant (including Valneva’s VLA2001; Clover Biopharmaceuticals SCB-2019; and Medigen’s MVC-COV1901).
Ryan Spencer, Dynavax's CEO, said: "We are honored to receive this award and to support the US government in developing a plague vaccine to protect the U.S. military members who put their lives at risk every day in service to the country.
“The development of a CpG 1018 adjuvanted plague vaccine is an important example of the broad utility of our adjuvant which we are leveraging to build our pipeline of new and improved vaccines. Our confidence in CpG 1018 is built on the successful development of our FDA-licensed 2-dose adult hepatitis B vaccine and the multiple late-stage COVID-19 vaccine candidates utilizing CpG 1018."
In July, researchers at the University of Oxford launched a Phase 1 trial to test a new plague vaccine based on the COVID-19 ChAdOx1 adenovirus viral vector platform. It is recruiting 40 adults aged 18-55.