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Dynavax has signed an agreement of approximately $ 22 million over two and a half years to develop the recombinant vaccine.
Randomized, placebo-controlled, multi-center, observer-blind clinical trial will evaluate the immunogenicity, safety and tolerability of rF1V vaccine antigens supplied by the US government in combination with Dynavax adjuvant CpG 1018 in adults 18 to 55 years old. The trial is expected to begin in 2022.
The award, funded by the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Defense of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) (JPM CBRN Medical), will also allow Dynavax to submit a New Drug Investigation Request (IND) from the United States Food and Drug Administration (FDA).
Military development
Well known for its widespread pandemics throughout history and especially during the Middle Ages, plague is a potentially fatal infectious disease caused by bacteria found in fleas and rodents or infected animals. It is caused by the bacteria, Yersinia pestis. The pulmonary plague bacteria have been identified by US authorities as an agent of concern for potential intentional release during a biological attack.
COL Ryan Eckmeier, Co-Project Leader for CBRN Medical, commented: “Advancing the development of a recombinant plague vaccine supports JPM CBRN Medical’s vision to provide a comprehensive, multi-layered medical countermeasures capability to enable a protected and unencumbered joint force to fight and win in any global CBRN battlespace. The rF1V vaccine will hopefully allow us to protect our military with fewer doses administered over a shorter period of time. “
Meanwhile, the disease can still be found in some parts of the world. Most human cases since the 1990s have been in Africa. A 2017 epidemic in Madagascar killed 171 people.
The rF1V vaccine was originally developed at the US Army Medical Research Institute for Infectious Diseases.
Adjuvant CpG 1018
CpG 1018 is used in the FDA-approved adult hepatitis B vaccine from Dynavax, Heplisav-B; while several late-stage COVID-19 vaccine candidates also use the adjuvant (including VLA2001 from Valneva; Clover Biopharmaceuticals SCB-2019; and MVC-COV1901 from Medigen).
Ryan Spencer, CEO of Dynavax, said: “We are honored to receive this award and to support the United States government in the development of a plague vaccine to protect the United States military personnel who put their lives at risk every day in service to the country.
“The development of a plague vaccine with CpG 1018 adjuvant is an important example of the broad utility of our adjuvant which we are exploiting to build our pipeline of new and improved vaccines. Our confidence in CpG 1018 is based on the successful development of our FDA-cleared 2-dose adult hepatitis B vaccine and multiple late-stage COVID-19 vaccine candidates using 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 adenovirus vector platform ChAdOx1. It recruits 40 adults aged 18 to 55.
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