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COMPLETEDPHASE1/PHASE2

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

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

NCT04681092•University Medical Center Groningen

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•SARS-CoV-2 serology by Akston (a quantitative anti-SARS-Cov-2 SP/RBD-specific IgG ELISA):
•Undetectable or \< 5 μg/mL titer and no known prior SARS-Cov-2 infection
•* Body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive
•* General good health, without significant medical illness, as determined via physical exam findings, ECG or vital signs
•Note: one retest of vital functions and ECG is allowed within the screening window
•\- No clinically significant laboratory abnormalities as determined by the investigator
•Note: one retest of lab tests is allowed within the screening window
•* Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose and procedures required for the study and is willing to participate in the study
•* Willing to adhere to the prohibitions and restrictions specified in this protocol
•* Non-smoker (including prior smokers having stopped smoking for more than 3 months at time of screening) or non-habitual smoker (habitual smokers are persons who smoke more than 4 cigarettes or other tobacco products on a weekly basis) and agree to not use tobacco products during confinement.
+10 more criteria

Exclusion Criteria

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Pregnant of breastfeeding females
•Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, hematologic, rheumatologic, endocrine, autoimmune, or renal disease
•Any laboratory test which is abnormal, and which is deemed by the Investigator(s) to be clinically significant
•Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol
•Current alcohol/illicit drug/nicotine abuse or addiction: history or evidence of current drug use or addiction (positive drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) or excessive use of alcohol at screening and Day -2.
•Presence of any febrile illness (T \> = 38.0°C or lab confirmed viral disease (PCR)) or symptoms suggestive of a viral respiratory infection within 1 weeks prior to vaccination
•Use of corticosteroids (excluding topical preparations for cutaneous or nasal use) or use of immunosuppressive drugs within 30 days before inoculation
•A history of anaphylaxis, history of allergic reaction to vaccine, known allergy to one of the components in AKS-452. Mild allergies without angio-oedema or treatment need can be included if deemed not to be of clinical significance (including but not limited to allergy to animals or mild seasonal hay fever)
•A history of asthma within the past 10 years, or a current diagnosis of asthma or reactive airway disease associated with exercise
+6 more criteria

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Key Dates

Start Date

April 6, 2021

Primary Completion Date

March 10, 2022

Completion Date

March 10, 2022

Last Updated

April 16, 2024

Enrollment

112

ACTUAL participants

Conditions

Covid19

Interventions

AKS-452

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Effect of the Covid-19 Pandemic Among Operated Patients

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Conversations You Want About Corona Virus Disease (COVID-19)

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COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy