NIH to Launch First in Series of Accelerated Safety Studies of Ebola Vaccine Candidates

In an August 28, 2014 press release, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) announced that initial human testing of an investigational vaccine to prevent Ebola virus disease will begin in the week of September 1, 2014, and be conducted by the NIAID. The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine's safety and ability to generate an immune system response in healthy adults. Testing will take place at the NIH Clinical Center in Bethesda, Maryland. The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. The other trials are set to launch in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response. In parallel, the NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain's Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali. Additionally, the U.S. Centers for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a Phase 1 safety study of the vaccine among healthy adults in that country.