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news.NewLink Genetics has received approval from the US Food and Drug Administration (FDA) to initiate Phase I human clinical trials with their Ebola vaccine candidate.
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The Public Health Agency of Canada (PHAC) has initially developed the vaccine, which is under an exclusive licensing arrangement with BioProtection Systems, a subsidiary of NewLink Genetics.
The new vaccine has been studied extensively and it has showed promise in both pre- and post-exposure vaccination of non-human primates exposed to lethal doses of the Ebola virus.
To launch the initial Phase I safety trial, the company is working with the US Department of Defense’s Defense Threat Reduction Agency (DTRA) and the Walter Reed Army Institute of Research (WRAIR).
The planned Phase I trial is designed to evaluate how healthy adults respond to various doses of vaccine.
The new vaccine is directed at the protein which forms the outer coat of Ebola virus and has been shown to induce antibodies that neutralize the virus.
Around 40 healthy volunteers will be immunized and then followed to determine the safety of the new vaccine.
The trial will also determine the magnitude and durability of any immune response, including whether these volunteers develop the same levels of antibody responses that are thought to protect monkeys in Ebola challenge studies.
The company intends to undertake additional Phase I studies to examine different dosing schedules and extension to vulnerable populations.
The additional studies are planned to be carried out with other collaborators such as National Institute of Allergy and Infectious Disease (NIAID), PHAC and the World Health Organization (WHO).
NewLink Genetics CEO and chief scientific officer Dr Charles Link said: "Our goal is to empower our research partners to conduct scientifically sound and ethically appropriate first in human studies," Link said.
"We are preparing for Phase 1 studies in North America, Europe and Africa, and recently signed agreements with third-party manufacturers to scale up vaccine production.
"NewLink’s team will be in Geneva this week at the WHO Ebola meeting to continue the process of sharing information and planning for additional studies."