Akston Biosciences Launches Phase I/II Clinical Trial of Second-Generation COVID-19 Vaccine

First subjects dosed with AKS-452, COVID-19 vaccine candidate in the Netherlands trial the vaccine is shelf-stable for 4 months at 25 degrees Celsius (77° Fahrenheit). 176 volunteers will participate in the clinical trial the safety and immune response read-outs expected in Q2 2021

Beverly, Mass. – April 12, 2021 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.”  
About the Phase I/II clinical trial
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. 
About AKS-452
AKS-452 has demonstrated robust protection against infection in immunized non-human primates after challenge with the SARS-CoV-2 virus. Although intended to be refrigerated for long-term storage, it has been shown to be shelf-stable for at least 4 months at 25 degrees Celsius (77° Fahrenheit) and maintains its potency for 1 month at 37 degrees Celsius (95° Fahrenheit).  The candidate does not include a live or weakened form of the virus, and has been engineered to use standard, low-cost, antibody manufacturing techniques, such that a single 2,000-liter production line could be capable of producing over one billion doses per year. 

Share this article

More services


This article is featured in:


Comment on this article

You must be registered and logged in to leave a comment about this article.