1. Thermostable bivalent filovirus vaccine protects against severe and lethal Sudan ebolavirus and marburgvirus infection.
- Author
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To A, Wong TAS, Ball AH, Lieberman MM, Yalley-Ogunro J, Cabus M, Nezami S, Paz F, Elyard HA, Borisevich V, Agans KN, Deer DJ, Woolsey C, Cross RW, Geisbert TW, Donini O, and Lehrer AT
- Subjects
- Animals, Humans, Vaccines, Combined, Sudan, Antibodies, Viral, Macaca fascicularis, Water, Ebolavirus, Marburgvirus, Hemorrhagic Fever, Ebola, Viral Vaccines
- Abstract
Although two vaccines for Zaire ebolavirus (EBOV) have been licensed and deployed successfully to combat recurring outbreaks of Ebolavirus Disease in West Africa, there are no vaccines for two other highly pathogenic members of the Filoviridae, Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV). The results described herein document the immunogenicity and protective efficacy in cynomolgus macaques of a single-vial, thermostabilized (lyophilized) monovalent (SUDV) and bivalent (SUDV & MARV) protein vaccines consisting of recombinant glycoproteins (GP) formulated with a clinical-grade oil-in-water nanoemulsion adjuvant (CoVaccine HT™). Lyophilized formulations of the vaccines were reconstituted with Water for Injection and used to immunize groups of cynomolgus macaques before challenge with a lethal dose of a human SUDV or MARV isolate. Sera collected after each of the three immunizations showed near maximal GP-binding IgG concentrations starting as early as the second dose. Most importantly, the vaccine candidates (monovalent or bivalent) provided 100% protection against severe and lethal filovirus disease after either SUDV or MARV infection. Although mild, subclinical infection was observed in a few macaques, all vaccinated animals remained healthy and survived the filovirus challenge. These results demonstrate the value that thermostabilized protein vaccines could provide for addressing an important gap in preparedness for future filovirus outbreaks., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Axel T. Lehrer and Oreola Donini are named inventors on a patent covering multivalent filovirus subunit vaccines (U.S. Patent 11,433,129B2). Jake Yalley-Ogunro, Mehtap Cabus, Sara Nezami, Fabian Paz, Hanne Andersen Elyard are current employees of BIOQUAL, Inc. Oreola Donini is a current employee of Soligenix Inc. All other authors declare no competing interests., (Copyright © 2023. Published by Elsevier Ltd.)
- Published
- 2024
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