RVSV-EBOV: Phase I data

A double-blind, placebo-controlled, U.S. Phase I trial in 26 healthy volunteers showed that 2 intramuscular injections of 3 and 20 million plaque-forming units (PFUs) VSV-ZEBOV given 28 days apart led to no safety concerns. The most common adverse events reported were injection-site pain, myalgia and fatigue. There were no deaths, serious adverse events or withdrawals due to an adverse event reported. Transient VSV viremia was reported in all subjects who received the vaccine. Additionally, all subjects receiving VSV-ZEBOV had seroconversion as measured by ELISA against the glycoprotein in the vaccine by day 28. The trial was conducted at NIH’s National Institute of Allergy and Infectious Diseases (NIAID). Data were published in The New England Journal of Medicine. ...