Challenge studies in immunized non-human primates has shown the vaccine offers ‘robust protection’ against the virus.
The candidate is dubbed a ‘second-generation’ vaccine thanks to its simple storage and transportation requirements: retaining its potency at 37˚ C / 95˚ F for a week, and being shelf-stable for four months at 25 ˚C / 77 ˚F (the vaccine should be refrigerated for long-term storage). It is also inexpensive to produce – a single 2,000 liter production line could be capable of producing over one billion doses a year.
Fighting the RBD
The vaccine, AKS-452, is based on Akston’s proprietary Fc fusion protein platform. It is designed to induce or boost a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) on the novel coronavirus’ spike protein.
Being the primary locus for infection, the RBD is highly conserved among mutated variants of the virus, and preclinical studies have also shown robust antibody neutralization of the B.1.1.7 (‘UK’) and B.1.351 (‘South Africa’) variants.
The Phase I/II clinical trial, an open-label study, will involve 176 healthy volunteers aged 18-65. Participants will receive one dose, or two doses 28 days apart, and the study will assess three-dose levels (22.5, 45, and 90 micrograms) to determine safety, tolerability and immune response in each regimen.
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.