COVID Innovation Fund Award: Production Capacity Scale-up for Dose-Sparing, Single-Shot Vaccines

Principal Investigator: Theodore Randolph, Ph.D., University of Colorado, Boulder and VitriVax, Inc

Medical Context

The need for effective measures to control the spread of COVID-19 is urgent, and numerous academic and commercial entities are working furiously to develop vaccines. Regardless of which antigens ultimately elicit successful immune responses, certain challenges of production scale and logistics will be universally required to provide protection to all the world’s citizens. Vaccines must typically be maintained under consistent, carefully controlled temperature conditions, require “booster” doses if the initial response is weak, and often need assistance from adjuvant compounds that enhance the host response to the vaccine.

Research Proposal

The University of Colorado and VitriVax, Inc. have developed a vaccine-manufacturing platform technology that addresses all of these challenges. The technology uses a process called atomic layer deposition (ALD) to deposit nanoscopic layers of vaccine adjuvants directly onto antigen particles. Dr. Randolph’s team has previously demonstrated, in pre-clinical animal trials against human papillomavirus, that this method produces vaccine formulations that are stable at temperatures up to 50°C (122°F), require only single doses, and generate robust protective immune responses without additional adjuvants. The team will now work to build a pilot-scale ALD system capable of producing 10,000-100,000 doses of COVID-19 vaccines per run, to be ready for use as candidate vaccine antigens begin to emerge over the next 6 to 12 months. The technology will thus be ready to manufacture thermally stable, self-adjuvanting, single-dose formulations of novel COVID-19 vaccines at the scale required for large human clinical trials.