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Trial completion: Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study (clinicaltrials.gov) - Apr 12, 2022
P1/2, N=112, Completed,
These favorable safety and immunogenicity profiles of the candidate vaccine as demonstrated in this phase II study are consistent with those of the phase I study (ClinicalTrials.gov: NCT04681092) and suggest that a total of 90 Active, not recruiting --> Completed
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Enrollment open, Trial completion date, Trial initiation date: Anti-COVID19 VaccinaTion AKS-452 BOOSTER (ACT-BOOSTER Study) (clinicaltrials.gov) - Apr 12, 2022
P2, N=600, Recruiting,
Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Jul 2022 --> Feb 2023 | Initiation date: Dec 2021 --> Apr 2022
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P1/2 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: Phase I interim results of a phase I/II study of the IgG-Fc fusion COVID-19 subunit vaccine, AKS-452. (Pubmed Central) - Feb 26, 2022
P1/2
All IgG titers were Th1-isotype skewed and efficiently bound mutant SP/RBD from several SARS-CoV-2 variants with strong neutralization potencies of live virus infection of cells (including alpha and delta variants). The favorable safety and immunogenicity profiles of this phase I study (ClinicalTrials.gov: NCT04681092) support phase II initiation of this room-temperature stable vaccine that can be rapidly and inexpensively manufactured to serve vaccination at a global scale without the need of a complex distribution or cold chain.
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Enrollment closed, Trial completion date, Trial primary completion date: Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study (clinicaltrials.gov) - Dec 20, 2021
P1/2, N=112, Active, not recruiting,
The favorable safety and immunogenicity profiles of this phase I study (ClinicalTrials.gov: NCT04681092) support phase II initiation of this room-temperature stable vaccine that can be rapidly and inexpensively manufactured to serve vaccination at a global scale without the need of a complex distribution or cold chain. Recruiting --> Active, not recruiting | Trial completion date: Oct 2021 --> May 2022 | Trial primary completion date: Sep 2021 --> Feb 2022
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Journal: Development of an IgG-Fc fusion COVID-19 subunit vaccine, AKS-452. (Pubmed Central) - Oct 27, 2021
Furthermore, ISA 720-adjuvanted AKS-452 was immunogenic in rabbits and non-human primates (NHPs) and protected from infection and clinical symptoms with live SARS-CoV-2 virus in NHPs (USA-WA1/2020 viral strain) and the K18 human ACE2-trangenic (K18-huACE2-Tg) mouse (South African B.1.351 viral variant). These preclinical studies support the initiation of Phase I clinical studies with adjuvanted AKS-452 with the expectation that this room-temperature stable, Fc-fusion subunit vaccine can be rapidly and inexpensively manufactured to provide billions of doses per year especially in regions where the cold-chain is difficult to maintain.
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Enrollment status, Trial completion date, Trial primary completion date: Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study (clinicaltrials.gov) - Jul 28, 2021
P1/2, N=112, Recruiting,
These preclinical studies support the initiation of Phase I clinical studies with adjuvanted AKS-452 with the expectation that this room-temperature stable, Fc-fusion subunit vaccine can be rapidly and inexpensively manufactured to provide billions of doses per year especially in regions where the cold-chain is difficult to maintain. Enrolling by invitation --> Recruiting | Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: Jun 2021 --> Sep 2021
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Enrollment status: Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study (clinicaltrials.gov) - Apr 23, 2021
P1/2, N=130, Enrolling by invitation,
Enrolling by invitation --> Recruiting | Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: Jun 2021 --> Sep 2021 Recruiting --> Enrolling by invitation
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