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Development of an IgG-Fc fusion COVID-19 subunit vaccine, AKS-452.
Alleva DG, Delpero AR, Scully MM, Murikipudi S, Ragupathy R, Greaves EK, Sathiyaseelan T, Haworth JR, Shah NJ, Rao V, Nagre S, Lancaster TM, Webb SS, Jasa AI, Ronca SE, Green FM, Elyard HA, Yee J, Klein J, Karnes L, Sollie F, Zion TC. Alleva DG, et al. Vaccine. 2021 Oct 29;39(45):6601-6613. doi: 10.1016/j.vaccine.2021.09.077. Epub 2021 Oct 5. Vaccine. 2021. PMID: 34642088 Free PMC article.
AKS-452 is a biologically-engineered vaccine comprising an Fc fusion protein of the SARS-CoV-2 viral spike protein receptor binding domain antigen (Ag) and human IgG1 Fc (SP/RBD-Fc) in clinical development for the induction and augmentation of neutralizing IgG titer …
AKS-452 is a biologically-engineered vaccine comprising an Fc fusion protein of the SARS-CoV-2 viral spike protein receptor bi …
A randomized phase I/II safety and immunogenicity study of the Montanide-adjuvanted SARS-CoV-2 spike protein-RBD-Fc vaccine, AKS-452.
Feitsma EA, Janssen YF, Boersma HH, van Sleen Y, van Baarle D, Alleva DG, Lancaster TM, Sathiyaseelan T, Murikipudi S, Delpero AR, Scully MM, Ragupathy R, Kotha S, Haworth JR, Shah NJ, Rao V, Nagre S, Ronca SE, Green FM, Aminetzah A, Sollie F, Kruijff S, Brom M, van Dam GM, Zion TC. Feitsma EA, et al. Vaccine. 2023 Mar 24;41(13):2184-2197. doi: 10.1016/j.vaccine.2023.02.057. Epub 2023 Feb 23. Vaccine. 2023. PMID: 36842886 Free PMC article. Clinical Trial.
METHODS: 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 g dose (cohort 1, 26 subjects) or two 45 g doses 28 days apart …
METHODS: This phase II randomized, open-labelled, parallel group study was conducted at a single site in The Netherlands with 52 healthy adu …
Phase I interim results of a phase I/II study of the IgG-Fc fusion COVID-19 subunit vaccine, AKS-452.
Janssen YF, Feitsma EA, Boersma HH, Alleva DG, Lancaster TM, Sathiyaseelan T, Murikipudi S, Delpero AR, Scully MM, Ragupathy R, Kotha S, Haworth JR, Shah NJ, Rao V, Nagre S, Ronca SE, Green FM, Aminetzah A, Sollie F, Kruijff S, Brom M, van Dam GM, Zion TC. Janssen YF, et al. Vaccine. 2022 Feb 23;40(9):1253-1260. doi: 10.1016/j.vaccine.2022.01.043. Epub 2022 Jan 31. Vaccine. 2022. PMID: 35115195 Free PMC article. Clinical Trial.
A single-center, open-label, phase I dose-finding and safety study was conducted with 60 healthy adults (18-65 years) receiving one or two doses 28 days apart of 22.5 g, 45 g, or 90 g of AKS-452 (i.e., six cohorts, N = 10 subjects per cohort). Primary endpoints were …
A single-center, open-label, phase I dose-finding and safety study was conducted with 60 healthy adults (18-65 years) receiving one or two d …
Immunogenicity phase II study evaluating booster capacity of nonadjuvanted AKS-452 SARS-Cov-2 RBD Fc vaccine.
Alleva DG, Feitsma EA, Janssen YF, Boersma HH, Lancaster TM, Sathiyaseelan T, Murikipudi S, Delpero AR, Scully MM, Ragupathy R, Kotha S, Haworth JR, Shah NJ, Rao V, Nagre S, Ronca SE, Green FM, Shaw SA, Aminetzah A, Kruijff S, Brom M, van Dam GM, Zion TC. Alleva DG, et al. NPJ Vaccines. 2024 Feb 21;9(1):40. doi: 10.1038/s41541-024-00830-2. NPJ Vaccines. 2024. PMID: 38383578 Free PMC article.
A single 90 g subcutaneous booster dose of AKS-452 was administered to 71 adults previously primed with a registered mRNA- or adenovirus-based vaccine and evaluated for 273 days. All AEs were mild and no SAEs were attributable to AKS-452. While all sub …
A single 90 g subcutaneous booster dose of AKS-452 was administered to 71 adults previously primed with a registered mRNA- or …