NIH Starts Phase 1 Trial Of NewLink Ebola Vaccine

The National Institutes of Health (NIH) announced that it has begun the Phase 1 trial of its second investigational Ebola vaccine VSV-ZEBOV.

VSV-ZEBOV is based partly on a genetically engineered version of vesicular stomatitis virus (VSV), which affects cattle, horses, swine, and rodents. The infection lasts three to four days in humans as a mild illness. In VSV-ZEBOV, the gene for the outer protein of the virus has been replaced with a corresponding component of the Zaire Ebola virus species. The vaccine is unable to cause a vaccinated person to become infected with Ebola. VSV-ZEBOV is currently licensed to Iowa-based NewLink Genetics Corp through its subsidiary, BioProtection Systems. Last month, the company received approval from the U.S. Food and Drug Administration (FDA) to go ahead with its Phase 1 clinical trial of the Ebola vaccine candidate.

The NIH Phase 1 trial involves 39 healthy adults who will be randomized to receive either placebo or an escalating dose of VSV-ZEBOV given as two intramuscular doses, known as a prime-boost strategy. A research team at the National Institute of Allergy and Infectious Diseases (NIAID) is conducting the Phase 1 trial of VSV-ZEBOV at the NIH’s Clinical Center in Bethesda, Maryland. The Walter Reed Army Institute of Research (WRAIR) is simultaneously conducting a trial of the VSV-ZEBOV as a single dose. The NIH said initial safety and immune response data from the trials are anticipated to be released by the end of the year.

Charles Link, CSO and CEO of NewLink Genetics, said, “We are pleased to recognize the extraordinary work of our partners to move the VSV-ZEBOV vaccine candidate from preclinical development to clinical testing in a matter of weeks rather than years. This level of support has been and will continue to be a critical asset in the ongoing process of evaluating and potentially bringing this investigational product to broader use in the fight against Ebola virus.”

NIAID Director Anthony S. Fauci, said, “The need for a vaccine to protect against Ebola infection is urgent. NIH welcomes the opportunity to collaborate with the U.S. Department of Defense to conduct human clinical tests of another promising — and hopefully, successful — Ebola vaccine candidate.”

The NIAID is also conducting clinical trials of another experimental Ebola vaccine candidate developed with GlaxoSmithKline.