Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-28 @ 3:47 PM
Study NCT ID:
NCT04681092
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACT
Brief Summary:
Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: