As the Ebola outbreak continues to ravage Liberia, Guinea and Sierra Leone, GlaxoSmithKline ($GSK) said Phase I trials of its experimental Ebola vaccine are expected to start in West Africa in the next few weeks, and Phase II trials are likely to begin in early 2015.
Phase I trials have already begun in the U.S. and U.K. So far, the NIH's National Institute of Allergy and Infectious Diseases (NIAID) has reported that no adverse side effects have occurred in healthy patients that have received the vaccine.
In an Oct. 1 assessment, the World Health Organization said the expedited evaluation of trial-ready Ebola vaccines is a "high priority," citing two vaccines that show promise--Glaxo's cAd3-ZEBOV, which is being developed in collaboration with NIAID's Vaccine Research Center, and rVSV-ZEBOV, which was conceived by the Public Health Agency of Canada in Winnipeg. The first Phase I trial of rVSV-ZEBOV will start this month.
The WHO's roadmap estimates that vaccine doses of both vaccines will be available for Phase II studies beginning in January 2015.
|NIAID Director Dr. Anthony Fauci|
The U.S. trial of the Glaxo vaccine, which began Sept. 2 at the NIH campus in Bethesda, MD, is expected to conclude by the end of November or beginning of December, NIAID Director Dr. Anthony Fauci said during a September congressional hearing.
Phase II trials are likely to include those at high-risk of Ebola, such as healthcare workers in the three affected countries in West Africa, Glaxo said in a statement.
Acquired in May 2013 in Glaxo's $325 million buyout of Okairos, the vaccine uses a chimpanzee cold virus vector containing two ebolavirus gene segments. This genetic material is carried into a cell and then dropped off, where it turns on the expression of a protein, which in turn elicits an immune response in the body.
The Ebola outbreak has gotten a lot closer to home for many Americans, with the first patient being diagnosed with the virus in a Houston hospital. According to an Oct. 1 update from the WHO, the death toll has reached 3,338 people, out of 7,178 total infections.
- get the WHO update on Ebola vaccines