A randomized phase I/II safety and immunogenicity study of the Montanide-adjuvanted SARS-CoV-2 spike protein-RBD-Fc vaccine, AKS-452. Previous interim data from a phase I study of AKS-452, a subunit vaccine comprising an Fc fusion of the respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein receptor binding domain (SP/RBD) emulsified in the water-in-oil adjuvant, Montanide™ ISA 720 , suggested a good safety and immunogenicity profile in healthy adults. This phase I study was completed and two dosing regimens were further evaluated in this phase II study. This phase II randomized, open-labelled, parallel group study was conducted at a single site in The Netherlands with 52 healthy adults (18 - 72 years) receiving AKS-452 subcutaneously at one 90 µg dose (cohort 1, 26 subjects) or two
Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study The study is designed as a combinatorial single-center open-label phase I and II clinical study design:I. a phase I dose-finding and safety / tolerability study combined with, II. a phase II safety / efficacy study on the biological activity of AKS-452 against COVID-19.To warrant more extensive development towards a phase III clinical study. The study will have a duration of approximately 4 months and will be executed at the University Medical Center Groningen, The Netherlands supported by the subsidizing party Akston Biosciences.
Anti-COVID19 VaccinaTion AKS-452 BOOSTER (ACT-BOOSTER Study) Aim: To investigate if a subcutaneous (s.c.) booster dose of 90 µg of the naked Akston AKS-452 vaccine (AKS-452X) at >= 3 months post initial vaccination, with any of the four registered vaccines, will boost the antibody titer and immune response in human healthy volunteers 4-6 weeks after s.c. injection. Hypothesis: A booster dose of naked (i.e. non-adjuvanted) AKS-452 vaccine will provide an enhanced immune response after vaccination with any of the registered vaccines against COVID-19.Primary objective: To determine the immunogenicity 4-6 weeks after subcutaneous injection of a booster dose of AKS-452X vaccine given at >=3 months post-initial vaccination (i.e. Pfizer [ Comirnaty], Moderna [Spikevax], Janssen [Ad26.COV2.S