NIH Launches Human Safety Study of Ebola Vaccine Candidate

Aug 29, 2014
By PharmTech Editors

Initial human testing on a vaccine to prevent Ebola virus co-developed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institute of Health, and GlaxoSmithKline (GSK) will begin the week of Sept. 1, according to the National Institutes of Health (NIH). 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.

NIH is testing the NIAID/GSK vaccine in partnership with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development. Healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali will participate in the testing.

The experimental NIAID/GSK vaccine will be conducted among 20 healthy adults ages 18-50 years. Participants will be divided into two groups of 10 participants each. One group will receive an intramuscular injection of the NIAID/GSK experimental vaccine, and the second group will receive a single injection of the same vaccine but at a higher dose.

Human safety testing for experimental Ebola vaccines is being expedited because of the ongoing Ebola virus outbreak in West Africa. According to the World Health Organization (WHO), more than 1400 suspected and confirmed deaths from Ebola infection have been reported in Guinea, Liberia, Nigeria, and Sierra Leone since the outbreak was first reported in March 2014.

NIAID will also test a version of the NIAID/GSK vaccine that contains a genetic material from the Zaire Ebola species. Initial safety and immunogenicity data from the Phase 1 trials of the NIAID/GSK investigational Ebola vaccine are expected in late 2014.

Source: NIH