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Research Project: Intervention Strategies to Control and Eradicate Foreign Animal Diseases of Swine

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Title: Lyophilization of ASFV vaccine candidate ASFV-G-Delta I177L offers long term stability

Author
item Espinoza, Nallely
item Spinard Iii, Edward
item RAI, AYUSHI - Oak Ridge Institute For Science And Education (ORISE)
item Ramirez Medina, Elizabeth
item VALLADARES, ALYSSA - Oak Ridge Institute For Science And Education (ORISE)
item MEYERS, AMANDA - Oak Ridge Institute For Science And Education (ORISE)
item Borca, Manuel
item Gladue, Douglas

Submitted to: Scientific Reports
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 11/15/2024
Publication Date: 12/30/2024
Citation: Espinoza, N.N., Spinard Iii, E.J., Rai, A., Ramirez Medina, E., Valladares, A., Meyers, A., Borca, M.V., Gladue, D.P. 2024. Lyophilization of ASFV vaccine candidate ASFV-G-Delta I177L offers long term stability. Scientific Reports. 14. Article 31613. https://doi.org/10.1038/s41598-024-80170-2.
DOI: https://doi.org/10.1038/s41598-024-80170-2

Interpretive Summary: This report describes the procedure for drying a live-attenuated African swine fever vaccine for long term storage and stability at increased temperatures. Drying vaccines allows for additional stability over frozen vaccines, currently laboratory produced vaccines must be kept at ultra-low temperatures for stability.

Technical Abstract: For over a century, African swine fever (ASF) has been causing outbreaks leading to devastating losses for the swine industry. The current pandemic of ASF has shown no signs of stopping and continues to spread causing outbreaks in additional countries. Currently, control relies mostly on culling infected farms, and strict bio-security procedures. Recently a vaccine, ASFV-G-Delta I177L was approved for use in Vietnam. In this study, we evaluate the long-term stability of lyophilized ASFV-G-Delta I177L. Understanding the stability of different formulations of vaccines is information necessary for deployment of vaccines to ASF outbreak areas, particularly those that do not have a reliable well established cold chain to ensure conservation of vaccine quality. In this report, we determined that ASFV-G-Delta I177L, when lyophilized under specific conditions, is stable for up to one year at 4oC, with similar vaccine titers after storage. Next-generation sequencing analysis also determined that lyophilization and long-term storage under these conditions had no effect on the genome of ASFV as the genome remained genetically identical to the original non-lyophilized form.