Through publication of data in Vaccine, this week Soligenix showcased the capabilities of its filovirus vaccine platform to formulate and provide heat stabilization for multiple antigen combinations of vaccine candidates: monovalent, bivalent, and trivalent.
The single-vial platform project was undertaken in collaboration with co-authors from the University of Hawaiʻi at Mānoa (UHM) and University of Colorado (UC).
“Filoviruses such as Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus are some of the most lethal viruses known, and they are endemic in areas of the world where the power supply and distribution network can be uncertain,” Dr. Axel Lehrer, associate professor at the UHM Department of Tropical Medicine, Medical Microbiology and Pharmacology, said. “A thermostabilized vaccine in a single-vial format would significantly enhance any public health response to a new outbreak, at its source. Our work to date has demonstrated the feasibility of rapid and efficient manufacturing, as well as the ability to thermostabilize multiple antigens that can then be stored at temperatures exceeding 100 degrees Fahrenheit.”
In theory, such a platform could allow acceleration of global vaccination campaigns, as it would undo many of the restrictions on capability. This would be particularly important for combating potential pandemics, like the ongoing one caused by COVID-19. In this case, the antigens and adjuvants used have also been previously demonstrated on non-human primates, where they proved capable of instilling protection.
In cases of monovalent vaccine formulations, in particular, the platform was able to thermostabilize antigens at temperatures up to 104 degrees Fahrenheit for up to three months, removing the critical need for refrigeration. Antibody responses were high, even up into trivalent concoctions, with a recent trivalent formulation bestowing protection to 75 percent of vaccinated non-human primates against subsequent infections of Sudan ebolavirus.
“Our combined vaccine platform includes three major components: a robust protein manufacturing process that has been demonstrated on multiple protein antigens, a novel nano-emulsion adjuvant which induces broad immunity and a formulation procedure which enables thermostabilization of the combination of adjuvant and antigen in a single vial,” Dr. Oreola Donini, senior vice president and Chief Scientific Officer of Soligenix, said. “Elements of this vaccine platform have been utilized in our ricin toxin, filovirus and COVID-19 vaccine candidates, indicating its broad applicability. The ability to package the vaccine candidates in a single-vial platform further adds to their developability, whether as a multivalent or individual monovalent vaccine, particularly against Marburg marburgvirus and Sudan ebolavirus where there are currently no available vaccines.”
Other potential benefits of the platform include a simple delivery format, its compatibility with ambient storage, and the ability to reduce logistical hurdles for vaccines.