- First subjects dosed with AKS-452, COVID-19 vaccine candidate in the Netherlands trial
- Vaccine is shelf-stable for 4 months at 25 degrees Celsius (77° Fahrenheit)
- 176 volunteers will participate in the clinical trial
- Safety and immune response read-outs expected in Q2 2021
The first volunteer receives Akston Bioscience‘s COVID-19 vaccine candidate, AKS-452, as part of a Phase I/II clinical trial. The vaccine is shelf-stable for 4 months at temperatures up to 25°C (77°F). (Photo: Rachel van de Vliert)
Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first participants have been dosed in an open-label trial of AKS-452, its COVID-19 vaccine candidate. The trial is managed by TRACER Europe B.V., a CRO specializing in fast-track clinical trials; and is being conducted at the University Medical Center Groningen (UMCG), one of the largest hospitals in the Netherlands. It will test both one- and two-dose regimens, each at three-dose levels.
“As a surgical oncologist, I treat patients every day who remain at great risk for COVID-19 infection,” said Schelto Kruijff, M.D. Ph.D., the trial’s principal investigator at the UMCG. “I am proud to be part of testing this highly innovative vaccine. From my volunteer work in Malawi and Kenya, I understand how important it would be to have a vaccine like this, which can be transported and stored for months without refrigeration.”
The Phase I/II clinical trial, an open-label study, will evaluate 176 healthy volunteers between the ages of 18 and 65. Participants will receive one dose or two doses 28 days apart and the protocol will assess three-dose levels (22.5, 45, and 90 micrograms) to determine safety, tolerability, and immune response.
