Akston Biosciences is set to commence a Phase II clinical trial of its protein subunit Covid-19 vaccine, AKS-452, as a booster in the Netherlands.
The move to conduct the trial of the vaccine, which is based on the company’s Fc-fusion protein platform, comes after securing regulatory approval in the country.
The vaccine can elicit a Th1/Th2 mixed immune response in patients against the novel coronavirus spike protein’s receptor-binding domain (RBD).
To be carried out at the University Medical Center Groningen (UMCG), the open-label trial will assess the immune system’s response to a 90µg booster dose of the AKS-452 vaccine in 600 subjects.
These healthy participants, aged 18 to 85 years, must have priorly been inoculated with vaccines of Pfizer, Moderna, Johnson & Johnson and AstraZeneca, registered by the European Medicines Agency (EMA).
Clinical research organisation TRACER Europe will manage the trial and has previously managed the Phase I and II trials for the vaccine.
To detect the effect of the booster over time, virus neutralisation activity, antibody levels and T cell response will be assessed at various follow-up visits.
The antibody titer level four weeks following the administration of the booster vaccine will be the trial’s primary efficacy endpoint.
Currently, a Phase II/III trial of AKS-452 given as a two-dose vaccine series is progressing in India enrolling 1,600 subjects.
The company anticipates primary endpoint results from the trial next month to enable an emergency use authorization submission in the first half of this year.
Akston Biosciences president and CEO Todd Zion said: “The clinical study results so far show that AKS-452, developed with our proprietary Fc-fusion protein platform, is well tolerated and effective as a primary vaccine.
“AKS-452 is very cost-effective to manufacture at scale, and it does not have the cold-chain constraints of many other vaccines, so it can be a practical way to provide protection while reducing the development and spread of new variants, by reaching difficult-to-reach populations.”
In December last year, the company reported that AKS-452 met the primary immunogenicity goals in a Phase II trial.