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US Army awards SRI International $4.7 million to manufacture, test encephalitis vaccine
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SRI International recently announced in a press release that the U.S. Army’s Joint Vaccine Acquisition Program has awarded the company with two agreements totaling $4.7 million to manufacture and test a potential new vaccine candidate against Venezuelan equine encephalitis, or VEE.
The VEE virus (VEEV), a type of alphavirus, usually causes mild to severe influenza-like symptoms; however, VEEV can also cause serious neurological complications, such as insomnia, seizures, confusion and coma. Young adults are more likely to develop serious complications, including encephalitis.
U.S. military service members can potentially be exposed to VEEV when they are deployed to regions where the virus is endemic, such as Central and South America. In addition, there is concern that aerosolized VEEV may be used as a biological weapon. The CDC has classified the virus as a category B bioterror agent, the release said.
Currently, there are no commercially available vaccines for VEEV. Previous candidates had insufficient tolerability profiles and failed to offer enough protection against the virus during studies of aerosolized VEEV exposure.
“We are honored by the opportunity to help our military develop a vaccine with better safety, tolerability and efficacy than previous VEEV vaccines,” George Hughes Jr., MD, FACP, physician investigator at SRI Biosciences, said in the release.
Under the agreement, SRI International will manufacture the vaccine at its production facility in Menlo Park, Calif. The company will test the vaccine in a phase 1 study at its Clinical Trials Unit in Plymouth, Mich., and will help submit an Investigational New Drug application to further advance the vaccine in clinical trials.
“We will apply SRI’s extensive clinical manufacturing and research expertise to provide this vaccine and then determine a safe and effective dose for individuals who may be exposed to aerosolized VEEV,” Jia-Hwa Fang, director of clinical manufacturing at SRI Biosciences, said in the release. “Successful manufacture and clinical testing of this vaccine could also advance efforts against other types of alphaviruses.”
According to the release, recruitment for the dose-escalation, safety, tolerance and immunogenicity study will begin after the vaccine is developed in the third quarter of 2017. Researchers plan to enroll 90 healthy adult volunteers.
Disclosure: Fang and Hughes are employees of SRI Biosciences.