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NIAID's role in the United States Government (USG) research response to the 2014-15 Ebola outbreak
Objective: As requested by the U.S. Department of Health and Human Services, NIAID developed a clinical research partnership with the Liberian government to accelerate development of vaccines/therapeutics for Ebola.
Methods: In an unprecedented collaboration with multiple partners (i.e. VRC, NIAID and Walter Reed Army Institute of Research), NIAID quickly launched two Phase I studies to assess safety of two leading Ebola vaccine candidates. NIAID’s Division of Clinical Research subsequently worked with Liberian partners to develop Phase II/ III protocols to evaluate the leading Ebola vaccine candidates and potential therapeutics.
Results: On February 2, 2015, the Liberia-U.S. Clinical Research Partnership launched the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), a Phase II/III 27, 000-subject randomized controlled trial to assess the safety and efficacy of two leading vaccine candidates. By March 13th PREVAIL had enrolled all 1500 planned Phase II participants. A therapeutics study, launched in Liberia and Sierra Leone, is still ongoing. In June, a natural history study to assess the impact of Ebola on survivors will be initiated.
Discussion: NIAID worked with USG and international partners to collaboratively respond to this urgent public health emergency. However, an even quicker overall research response could have prevented thousands of deaths, suffering, and economic hardships. The global health community must integrate and support regional consortiums for clinical research to ensure preparedness for future infectious disease outbreaks.
Learning Areas:
Protection of the public in relation to communicable diseases including prevention or controlProvision of health care to the public
Public health or related research
Learning Objectives:
Explain how the Ebola outbreak of 2014-15 evolved over time;
Describe the contribution of the National Institute of Allergy and Infectious Diseases (NIAID) to the USG research response, including development of clinical trials to evaluate the two leading vaccine candidates, potential Ebola therapeutics, and an Ebola survivors study; and
Discuss how gender differences influenced study enrollment and observed health characteristics among study participants.
Keyword(s): International Health, Emergency Preparedness
Qualified on the content I am responsible for because: I am the operations lead for the NIAID DCR Ebola efforts in West Africa. I am also the Deputy Director for Operations and Management for the DCR. I have worked in clinical research operations and management for over 15 years. I have led the operations for many clinical research networks internationally and domestically.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.