The Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan (USask) announced Tuesday that they have received a notice of authorization from Health Canada to initiate a Phase 1 clinical vaccine trial.
“The approval to initiate a human clinical trial is a milestone for VIDO,” VIDO Director and CEO Dr. Volker Gerdts said in a press release.
“This is the first of our two COVID-19 subunit vaccines in development and demonstrates the quality of our research, development and partnerships.”
Subunit-based vaccines are a proven technology that has been used in many commercially available vaccines—including for hepatitis, diphtheria, and whooping cough—with an excellent safety profile. These well-established vaccines are relatively stable and have not required ultra cold storage temperatures.
The authorization from Health Canada enables the Canadian Center for Vaccinology (CCfV) in Halifax to begin recruiting volunteers for the first Phase 1 clinical trial. CCfV anticipates that the volunteers will be vaccinated in January.
“This is the first university-based COVID-19 vaccine to begin Phase 1 testing at CCfV. The purpose of this trial is to demonstrate the safety of the vaccine in humans,” CCfV Director Dr. Scott Halperin said.
Gerdts explained that assuming all goes well with the trials and in obtaining regulatory approvals, VIDO expects to have at least one of its vaccines ready for use by late 2021, Gerdts said.
“To have sustainable long-term vaccine access, I think it’s important for Canada to continue on with its own vaccines,” he said. “COVID-19 is not going to go away.”
VIDO’s vaccine development leveraged the expertise of several international and national partners. The adjuvant (Sepivac SWE™) was developed by Seppic in collaboration with the Vaccine Formulation Institute (VFI) and is based on technology recognized for its efficacy and safety in influenza vaccines. The vaccine antigen developed by VIDO was produced under good manufacturing practices (GMP) at Biodextris using a cell line from the National Research Council of Canada.
The clinical trial application for the second vaccine candidate, which uses an adjuvant developed by VIDO and collaborators, will be submitted when GMP manufacturing of the adjuvant is completed by Dalton Pharma Services.