Soligenix, Inc. recently announced data showing a more heat stable vaccine formulation of a human papillomavirus (HPV). The work was carried at the University of Colorado and led by Drs. Randolph and Garcea who showed the successful transformation of a commercial virus-like particle (VLP) in a vaccine form requiring cold-chain storage into a more stable subunit appropriated for ambient temperatures.
This project was funded by a grant from the University of Colorado Seed for cervical cancer and it is Soligenix’s ThermoVax technology first demonstration for a subunit based commercial vaccine. ThermoVax had been proved successful to enhance the thermostability of a ricin vaccine (RiVax) – allowing a stability of up to 1 year at 40 degrees Celsius – and an anthrax vaccine (VeloThrax) – 16 weeks at 70 degrees Celsius. Further, in this study published in the European Journal of Pharmaceutics and Biopharmaceutics, the novel HPV vaccine was stable for at least 12 weeks at 50 degrees Celsius (122 degrees Fahrenheit).
Researchers managed to immunize mice with the ThermoVax-stabilized HPV subunit vaccine, achieving immune responses equal to the commercial HPV vaccine, Cervarix, as measured by total antibody levels and neutralizing antibody levels. The immune responses to Cervarix was highly reduced after the vaccine had been stored for 12 weeks at 50 degrees Celsius while ThermoVax retained its initial efficacy.
“The use of subunit vaccines has always been hindered by concerns about thermostability. The use of this technology, invented at theUniversity of Colorado, clearly overcomes these concerns and offers broad applicability in many commercial indications. In addition to the cost-savings incurred for vaccines for the developed world, the use of this technology also offers the opportunity for more effective vaccination in the developing world,” explained Theodore Randolph from the University of Colorado, Boulder.
“This is the first application of ThermoVax™, our proprietary thermostabilization system, with a commercial vaccine indication. This work illustrates the broad applicability of this technology platform. We are continuing to develop ThermoVax™ in the context of our RiVax™ vaccine under a recent NIAID contract award of up to $24.7M over 6 years,” said Christopher Schaber, Soligenix’s CEO and President.