NCT04681092

Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study

Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	AKS-452	s.c. or i.m. vaccination

Timeline

• Start date: 2021-04-06
• Primary completion: 2022-03-10
• Completion: 2022-03-10
• First posted: 2020-12-23
• Last updated: 2024-04-16

Locations

1 site across 1 country: Netherlands