Cargando…

A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development

A United States Government (USG) interagency group, the Filovirus Animal Non-Clinical Group (FANG), has been established to support the development of biodefense medical countermeasures (MCMs). As both vaccines and therapeutics are licensed using “non-traditional pathways”, such as the U.S. Food and...

Descripción completa

Detalles Bibliográficos
Autores principales: Taylor, Kimberly L., Lanning, Lynda, Wolfraim, Lawrence, Shrivastava Gales, Sonia, Sico, Colleen, Dowling, William E., Ward, Lucy A., Florence, William C., Nuzum, Edwin, Bryant, Paula R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9412622/
https://www.ncbi.nlm.nih.gov/pubmed/36016089
http://dx.doi.org/10.3390/vaccines10081201
_version_ 1784775539649675264
author Taylor, Kimberly L.
Lanning, Lynda
Wolfraim, Lawrence
Shrivastava Gales, Sonia
Sico, Colleen
Dowling, William E.
Ward, Lucy A.
Florence, William C.
Nuzum, Edwin
Bryant, Paula R.
author_facet Taylor, Kimberly L.
Lanning, Lynda
Wolfraim, Lawrence
Shrivastava Gales, Sonia
Sico, Colleen
Dowling, William E.
Ward, Lucy A.
Florence, William C.
Nuzum, Edwin
Bryant, Paula R.
author_sort Taylor, Kimberly L.
collection PubMed
description A United States Government (USG) interagency group, the Filovirus Animal Non-Clinical Group (FANG), has been established to support the development of biodefense medical countermeasures (MCMs). As both vaccines and therapeutics are licensed using “non-traditional pathways”, such as the U.S. Food and Drug Administration’s (FDA) Animal Rule (AR), non-human primate (NHP) models and associated assays have been developed and standardized across BSL4 testing sites to evaluate candidate products. Vaccine candidates are evaluated using these NHP models, and through this public–private partnership, a meta-analysis of NHP control data has been conducted and submitted to the FDA as a master file. This is an example of how existing NHP control data can be leveraged in lieu of conducting separate natural history studies at multiple testing facilities to demonstrate the consistency of a standardized animal model for vaccine development. As a result, animal use can be minimized and the duplication of effort avoided, thus reducing the amount of time needed to conduct additional studies, as well as the cost of vaccine candidate development. This successful strategy may be applied to other pathogens of high consequence for vaccine development, and shows how strategic preparedness for biodefense can be leveraged in response to outbreaks and public health emergencies.
format Online
Article
Text
id pubmed-9412622
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-94126222022-08-27 A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development Taylor, Kimberly L. Lanning, Lynda Wolfraim, Lawrence Shrivastava Gales, Sonia Sico, Colleen Dowling, William E. Ward, Lucy A. Florence, William C. Nuzum, Edwin Bryant, Paula R. Vaccines (Basel) Review A United States Government (USG) interagency group, the Filovirus Animal Non-Clinical Group (FANG), has been established to support the development of biodefense medical countermeasures (MCMs). As both vaccines and therapeutics are licensed using “non-traditional pathways”, such as the U.S. Food and Drug Administration’s (FDA) Animal Rule (AR), non-human primate (NHP) models and associated assays have been developed and standardized across BSL4 testing sites to evaluate candidate products. Vaccine candidates are evaluated using these NHP models, and through this public–private partnership, a meta-analysis of NHP control data has been conducted and submitted to the FDA as a master file. This is an example of how existing NHP control data can be leveraged in lieu of conducting separate natural history studies at multiple testing facilities to demonstrate the consistency of a standardized animal model for vaccine development. As a result, animal use can be minimized and the duplication of effort avoided, thus reducing the amount of time needed to conduct additional studies, as well as the cost of vaccine candidate development. This successful strategy may be applied to other pathogens of high consequence for vaccine development, and shows how strategic preparedness for biodefense can be leveraged in response to outbreaks and public health emergencies. MDPI 2022-07-28 /pmc/articles/PMC9412622/ /pubmed/36016089 http://dx.doi.org/10.3390/vaccines10081201 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Taylor, Kimberly L.
Lanning, Lynda
Wolfraim, Lawrence
Shrivastava Gales, Sonia
Sico, Colleen
Dowling, William E.
Ward, Lucy A.
Florence, William C.
Nuzum, Edwin
Bryant, Paula R.
A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development
title A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development
title_full A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development
title_fullStr A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development
title_full_unstemmed A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development
title_short A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development
title_sort u.s. government-coordinated effort to leverage non-human primate data to facilitate ebolavirus vaccine development
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9412622/
https://www.ncbi.nlm.nih.gov/pubmed/36016089
http://dx.doi.org/10.3390/vaccines10081201
work_keys_str_mv AT taylorkimberlyl ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT lanninglynda ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT wolfraimlawrence ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT shrivastavagalessonia ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT sicocolleen ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT dowlingwilliame ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT wardlucya ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT florencewilliamc ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT nuzumedwin ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT bryantpaular ausgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT taylorkimberlyl usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT lanninglynda usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT wolfraimlawrence usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT shrivastavagalessonia usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT sicocolleen usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT dowlingwilliame usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT wardlucya usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT florencewilliamc usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT nuzumedwin usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment
AT bryantpaular usgovernmentcoordinatedefforttoleveragenonhumanprimatedatatofacilitateebolavirusvaccinedevelopment