Selection of Filovirus Isolates for Vaccine Development Programs
The continuing outbreaks of ebola virus disease highlight the ongoing threat posed by filoviruses. Fortunately, licensed vaccines and therapeutics are now available for <i>Zaire ebolavirus</i>. However, effective medical countermeasures, such as vaccines for other filoviruses such as <...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-09-01
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| Series: | Vaccines |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-393X/9/9/1045 |
| _version_ | 1797516996264329216 |
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| author | Daniel N. Wolfe Carol L. Sabourin Michael J. Merchlinsky William C. Florence Larry A. Wolfraim Kimberly L. Taylor Lucy A. Ward |
| author_facet | Daniel N. Wolfe Carol L. Sabourin Michael J. Merchlinsky William C. Florence Larry A. Wolfraim Kimberly L. Taylor Lucy A. Ward |
| author_sort | Daniel N. Wolfe |
| collection | DOAJ |
| description | The continuing outbreaks of ebola virus disease highlight the ongoing threat posed by filoviruses. Fortunately, licensed vaccines and therapeutics are now available for <i>Zaire ebolavirus</i>. However, effective medical countermeasures, such as vaccines for other filoviruses such as <i>Sudan ebolavirus</i> 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 <i>Sudan ebolavirus</i> 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. |
| first_indexed | 2024-03-10T07:08:43Z |
| format | Article |
| id | doaj.art-73596e1a6cfd4c0db6c1fc5902d3557b |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-10T07:08:43Z |
| publishDate | 2021-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-73596e1a6cfd4c0db6c1fc5902d3557b2023-11-22T15:35:19ZengMDPI AGVaccines2076-393X2021-09-0199104510.3390/vaccines9091045Selection of Filovirus Isolates for Vaccine Development ProgramsDaniel N. Wolfe0Carol L. Sabourin1Michael J. Merchlinsky2William C. Florence3Larry A. Wolfraim4Kimberly L. Taylor5Lucy A. Ward6U.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, USATunnell 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, USAU.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, USAU.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Rockville, MD 20852, USAU.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Rockville, MD 20852, USAU.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Rockville, MD 20852, USAU.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, USAThe continuing outbreaks of ebola virus disease highlight the ongoing threat posed by filoviruses. Fortunately, licensed vaccines and therapeutics are now available for <i>Zaire ebolavirus</i>. However, effective medical countermeasures, such as vaccines for other filoviruses such as <i>Sudan ebolavirus</i> 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 <i>Sudan ebolavirus</i> 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.https://www.mdpi.com/2076-393X/9/9/1045ebolaSudanMarburgfilovirusanimal ruleviral isolate |
| spellingShingle | Daniel N. Wolfe Carol L. Sabourin Michael J. Merchlinsky William C. Florence Larry A. Wolfraim Kimberly L. Taylor Lucy A. Ward Selection of Filovirus Isolates for Vaccine Development Programs Vaccines ebola Sudan Marburg filovirus animal rule viral isolate |
| title | Selection of Filovirus Isolates for Vaccine Development Programs |
| title_full | Selection of Filovirus Isolates for Vaccine Development Programs |
| title_fullStr | Selection of Filovirus Isolates for Vaccine Development Programs |
| title_full_unstemmed | Selection of Filovirus Isolates for Vaccine Development Programs |
| title_short | Selection of Filovirus Isolates for Vaccine Development Programs |
| title_sort | selection of filovirus isolates for vaccine development programs |
| topic | ebola Sudan Marburg filovirus animal rule viral isolate |
| url | https://www.mdpi.com/2076-393X/9/9/1045 |
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