Profectus BioSciences has started a Phase I trial of its VesiculoVax-vectored vaccine to treat Ebola.
Ebola is a filovirus that causes periodic outbreaks of a highly contagious and infectious human disease associated with severe hemorrhagic fever, with a mortality rate that ranges between 50% and 90%.
Transmitted from wild animals, the virus spreads in the human population through human-to-human transmission.
The infection affects multiple organs in the body and often causes severe bleeding (hemorrhage).
The Ebola vaccine has already shown promising results in monkeys during preclinical studies.
The Phase I study will evaluate the safety and immunogenicity of the vaccine in humans at doses shown to protect monkeys.
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Around 39 people will be enroled into three groups that will receive progressively higher doses of the vaccine by intramuscular injection.
Profectus BioSciences chief scientific officer John H. Eldridge said: "This first study is designed to quickly establish the safety and immunogenicity of our attenuated VSV-vectored Ebola vaccine.
"The next step, anticipated for mid-next year, will be a trial of our trivalent vaccine to protect against all species of Ebola and Marburg viruses. That will be followed by the testing of a freeze-dried formulation that will allow field use without refrigerated storage."
The evaluation of the filovirus vaccine is being backed by the US Department of Defense Medical Countermeasures Systems-Joint Vaccine Acquisition Program (MCS-JVAP), both directly and through contracts with Battelle, the Biomedical Advanced Research and Development Authority (BARDA), and the National Institutes of Health (NIH).
The firm will manufacture the vaccine to provide pre and post-exposure protection against exposure with all major strains of Ebola virus.
It has received $8.5m in funding from the Department of the Army, US Army Contracting Command, Aberdeen Proving Ground, and the Natick Contracting Division.
Image: Electron micrograph of an Ebola virus virion. Photo: courtesy of CDC / Cynthia Goldsmith.