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SRI International has been awarded two agreements worth $4.7 million to manufacture and conduct clinical testing on a potential new vaccine against Venezuelan equine encephalitis (VEE), a serious viral infection for which there is currently no commercially available vaccine.
The VEE virus (VEEV) is a type of alphavirus that typically causes mild to severe influenza-like symptoms, but can progress to serious neurological complications such as insomnia, seizures, confusion, and coma. Young adults, who are in the typical age ranges of US warfighters, are more likely to develop serious and potentially deadly VEEV complications, including encephalitis. Military service members can be exposed to VEEV when deployed to regions where the virus is endemic (e.g., Central and South America), or where aerosolized VEEV could be used as a biological weapon.
The Centers for Disease Control has classified VEEV as a category B bioterror agent. Previous VEEV vaccines had issues with tolerability and failed to stimulate adequate levels of protective antibodies against VEEV in 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,” said George Hughes, Jr., M.D., FACP, physician investigator, SRI Biosciences, and principal investigator for the clinical study.
Under the agreement, sponsored by the United States Army’s Joint Vaccine Acquisition Program (JVAP), SRI will manufacture the vaccine in its Good Manufacturing Practice (GMP) certified production facility in Menlo Park, California and test the novel compound in a phase 1 study at SRI’s Clinical Trials Unit (CTU) in Plymouth, Mich. SRI will also assist in submitting the Investigational New Drug application to enable human 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,” said Jia-Hwa Fang, director of Clinical Manufacturing, SRI Biosciences. “Successful manufacture and clinical testing of this vaccine could also advance efforts against other types of alphaviruses.”
Once the vaccine product is developed, researchers at SRI’s CTU will conduct a dose-escalation, safety, tolerance, and immunogenicity study of the virus-like particle (VLP) vaccine in 90 healthy adult volunteers. SRI’s 9,200 square-foot CTU in the Michigan Life Science and Innovation Center facility includes an investigational pharmacy, a sample-processing laboratory, and amenities to accommodate extended overnight stays for research participants. Recruitment for healthy adult volunteers will begin in Q3 2017.
This effort is sponsored by the US Government under Other Transaction number W15QKN-16-9-1002 between the Medical CBRN Defense Consortium (MCDC) and the Government. The US Government is authorized to reproduce and distribute reprints of this document for Governmental purposes notwithstanding any copyright notation thereon.
Sri international, manufacture, test vaccine against venezuelan equine encephalitis
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