Industry News: Phase I Human Trials for Ebola Vaccine Begin this Week

04 Sep 2014

The first human trial for an investigational Ebola vaccine is set to begin this week.

The ongoing Ebola outbreak in West Africa prompted the National Institutes of Health to expedite safety testing for several vaccines already in the works. Since March, the deadly virus has killed 1,552 people, according to the World Health Organization, which predicted last week that the virus could infect 20,000 people in the next six months.

This urgently required, protective Ebola vaccine is different from the experimental Ebola drug ZMapp, which two Americans received last month and is designed to treat an ‘existing’ Ebola infection, rather than prevent one.

The NIH is developing the vaccine with GlaxoSmithKline and it has not yet been tested in humans. A phase 1 clinical trial in 20 humans is set to begin this week at the NIH Clinical Center in Bethesda, Maryland.

Researchers will use the study to determine whether the vaccine is safe and to see whether it prompts an immune response necessary to protect against Ebola. No human subjects will be infected with Ebola.

If successful, the vaccine could be administered to a limited number of health workers, and enable GlaxoSmithKline to manufacture 10,000 doses of the vaccine while the trials are ongoing. If the vaccine trials are successful, it will be able to make stocks available immediately to the World Health Organization.

The NIH said it should have initial data from the trial in late 2014.