Selection of Filovirus Isolates for Vaccine Development Programs
Daniel N. Wolfe,
Carol L. Sabourin,
Michael J. Merchlinsky,
William C. Florence,
Larry A. Wolfraim,
Kimberly L. Taylor,
Lucy A. Ward
Affiliations
Daniel N. Wolfe
U.S. Department of Health and Human Services (DHHS), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), Washington, DC 20201, USA
Carol L. Sabourin
Tunnell Government Services, Inc., Supporting Biomedical Advanced Research & Development Authority (BARDA), Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (DHHS), Washington, DC 20201, USA
Michael J. Merchlinsky
U.S. Department of Health and Human Services (DHHS), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), Washington, DC 20201, USA
William C. Florence
U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Rockville, MD 20852, USA
Larry A. Wolfraim
U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Rockville, MD 20852, USA
Kimberly L. Taylor
U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Rockville, MD 20852, USA
Lucy A. Ward
U.S. Department of Defense (DOD), Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), Fort Detrick, MD 21702, USA
The continuing outbreaks of ebola virus disease highlight the ongoing threat posed by filoviruses. Fortunately, licensed vaccines and therapeutics are now available for Zaire ebolavirus. However, effective medical countermeasures, such as vaccines for other filoviruses such as Sudan ebolavirus and the Marburg virus, are presently in early stages of development and, in the absence of a large outbreak, would require regulatory approval via the U.S. Food and Drug Administration (FDA) Animal Rule. The selection of an appropriate animal model and virus challenge isolates for nonclinical studies are critical aspects of the development program. Here, we have focused on the recommendation of challenge isolates for Sudan ebolavirus and Marburg virus. Based on analyses led by the Filovirus Animal and Nonclinical Group (FANG) and considerations for strain selection under the FDA Guidance for the Animal Rule, we propose prototype virus isolates for use in nonclinical challenge studies.
