SRI International Initiates Clinical Trial Testing of a Vaccine Against Venezuelan Equine Encephalitis | SRI International

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SRI International Initiates Clinical Trial Testing of a Vaccine Against Venezuelan Equine Encephalitis

MENLO PARK, Calif.—August 28, 2018— SRI International has initiated dosing in a clinical trial evaluating a new vaccine against Venezuelan equine encephalitis (VEE), a serious viral infection for which there is currently no commercially available vaccine. SRI is conducting clinical testing under an agreement sponsored by the United States Army’s Joint Product Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) Medical Countermeasure Systems (MCS) Joint Vaccine Acquisition Program (JVAP).

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The VEE virus (VEEV) is an alphavirus that causes mild to severe influenza-like symptoms, but can progress, in a small number of individuals, to severe encephalitis with neurological complications such as seizures, paralysis, or coma. Military service members can be exposed to VEEV from the bite of an infected mosquito when deployed to regions where the virus is endemic (e.g., Central and South America), or from aerosol exposure if VEEV is 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 or failed to provide adequate protection against aerosol exposure to VEEV.

“The initiation of human testing for this VEE monovalent virus-like particle vaccine is a significant milestone, and we are hopeful that when this trial is completed it will show we have a VEEV vaccine with better safety, tolerability, and immunogenicity than previous vaccines,” said George Hughes, Jr., M.D., FACP, medical director of SRI Biosciences and physician investigator for the clinical study.

The clinical trial is being conducted at SRI’s Clinical Trials Unit (CTU) in Plymouth, Michigan. SRI anticipates that the study, which will be conducted in 90 healthy adult volunteers, will be completed in 15 months.

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.

The VEEV vaccine was developed and manufactured by the National Institute of Allergy and Infectious Diseases (NIAID) as part of an Interagency Agreement with JVAP.  Manufacturing of the finished vaccine product was performed by SRI in its Good Manufacturing Practice (GMP)-certified production facility in Menlo Park, California. SRI holds the Investigational New Drug (IND) for the vaccine, with plans to transfer the IND to the U.S. Government at completion of the trial.

This effort is sponsored by the U.S. Government under Other Transaction number W15QKN-16-9-1002 between the Medical CBRN Defense Consortium (MCDC) and the Government. The U.S. Government is authorized to reproduce and distribute reprints of this document for Governmental purposes notwithstanding any copyright notation thereon.

The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.