April 12, 2021 -- Akston Biosciences has begun a phase I/II clinical trial for its second-generation COVID-19 vaccine.
The trial is being conducted in at the University Medical Center Groningen in the Netherlands and includes 176 volunteers between the ages of 18 and 65 who will be dosed with AKS-452, the company's COVID-19 vaccine candidate. The trial will test one- and two-dose regimens and three dose levels (22.5 µg, 45 µg, and 90 µg). The vaccine is shelf stable for four months at 77○ F, according to the firm.
AKS-452 is based on Akston's proprietary Fc fusion protein platform and is a SARS-CoV-2 subunit vaccine designed to induce a T helper type I (Th1)/Th2 mixed immune response against the receptor-binding domain of the SARS-CoV-2 spike protein. The Fc moiety helps in delivering the vaccine to antigen-presenting cells via binding to the Fc-gamma receptor, and subsequent antigen processing and presentation to CD4+ T cells. Preclinical studies of the vaccine point to robust antibody neutralization of SARS-CoV-2 variants of concern.
Akston expects safety and immune response results to be available in the second quarter of this year.