drugset / Trial / NCT04681092
Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study
Phase 1/2
Completed
112 enrolled
University Medical Center Groningen
Akston Biosciences Corporation · collab
Non-randomizedSingle-groupOpen-labelPrevention
Summary
Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study
Timeline
- Start
- 2021-04-06
- Primary completion
- 2022-03-10
- Completion
- 2022-03-10
Outcome
Met primary endpoint
release “today announced positive data from the Phase II clinical trial of its second-generation SARS-CoV2 vaccine candidate, AKS-452. The interim analysis showed a robust overall 98% seroconversion response” akstonbio.com ↗
release “Primary immunogenicity endpoints were met” akstonbio.com ↗
Publications
- 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. A randomized phase I/II safety and immunogenicity study of the Montanide-adjuvanted SARS-CoV-2 spike protein-RBD-Fc vaccine, AKS-452. Vaccine. 2023 Mar 24;41(13):2184-2197. doi: 10.1016/j.vaccine.2023.02.057. Epub 2023 Feb 23.
- 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. Phase I interim results of a phase I/II study of the IgG-Fc fusion COVID-19 subunit vaccine, AKS-452. Vaccine. 2022 Feb 23;40(9):1253-1260. doi: 10.1016/j.vaccine.2022.01.043. Epub 2022 Jan 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AKS-452 | Vaccine | 22.5 ug | Subcutaneous |
| Subject | AKS-452 | Vaccine | 45 ug | Subcutaneous |
| Subject | AKS-452 | Vaccine | 90 ug | Subcutaneous |