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

Sponsor

University Medical Center Groningen (Other)

Overall Status

Completed

CT.gov ID

NCT04681092

Collaborator

Akston Biosciences Corporation (Other)

112

Enrollment

Location

Arms

11.1

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label clinical study of AKS-452 COVID-19 vaccination study

Condition or Disease	Intervention/Treatment	Phase
Covid19	Biological: AKS-452	Phase 1/Phase 2

Detailed Description

The study is designed as a combinatorial single-center open-label phase I and II clinical study design:

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 Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single-center, open-label, combinatorial safety, tolerability and exploratory efficacySingle-center, open-label, combinatorial safety, tolerability and exploratory efficacy

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 6, 2021

Actual Primary Completion Date :

Mar 10, 2022

Actual Study Completion Date :

Mar 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AKS-452 s.c.(A) Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL) single-dose	Biological: AKS-452 s.c. or i.m. vaccination
Experimental: AKS-452 s.c. (B) Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL), two-dose	Biological: AKS-452 s.c. or i.m. vaccination
Experimental: AKS-452 s.c. (C) Subcutaneous injection of pre-defined dose (45 ug, 205 uL), single-dose	Biological: AKS-452 s.c. or i.m. vaccination
Experimental: AKS-452 s.c. (D) Subcutaneous injection of pre-defined dose (45 ug, 250 uL), two-dose	Biological: AKS-452 s.c. or i.m. vaccination
Experimental: AKS-452 s.c. (E) Subcutaneous injection of pre-defined dose (90 ug, 500 uL), single-dose	Biological: AKS-452 s.c. or i.m. vaccination
Experimental: AKS-452 s.c. (F) Subcutaneous injection of pre-defined dose (90 ug, 500 uL), two-dose	Biological: AKS-452 s.c. or i.m. vaccination
Experimental: Phase 2, single-dose injection Subcutaneous injection of selected dose based on phase 1 data, dose (90 ug, 500 uL)	Biological: AKS-452 s.c. or i.m. vaccination
Experimental: Phase 2, two-dose injection Subcutaneous injection of selected dose based on phase 1 data, dose (45 ug, 500 uL) twice.	Biological: AKS-452 s.c. or i.m. vaccination

Outcome Measures

Primary Outcome Measures

Safety / Tolerability [35 days]
CTCAE-scoring

Secondary Outcome Measures

Immunogenicity [180 days]
Antibody response COVID-19

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.
Negative alcohol breath test and urine drug screen at screening and upon check-in at the clinical site.
Negative hepatitis panel (including hepatitis B surface Ag and anti-hepatitis C virus Abs) and negative human immunodeficiency virus Ab and Ag screens at screening
Female subjects should fulfil one of the following criteria:
At least 1 year post-menopausal (amenorrhea >12 months and/or follicle stimulating hormone >30 mIU/mL) at screening;
Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
Will use adequate forms of contraceptives from screening to discharge.
Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge
Note: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, double barrier, sterilization and vasectomy
Female subject has a negative pregnancy test at screening and upon check-in at the clinical site.
Note: pregnancy testing will consist of a serum pregnancy test at screening and urine pregnancy tests at other (dosing) visits, in all women.

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
Receipt of a licensed vaccine within 4 weeks prior to viral inoculation
Received any experimental SARA-CoV-2 vaccine or drug
Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to vaccination.
Receipt of another investigational agent within 30 days or 5 times the product half-life (whichever is longest) prior to vaccination
Shares household with /works with immunocompromised individual(s), adults with significant cardiopulmonary disease, persons with significant asthma, institutionalized elderly or elderly with functional disability
Deprived of freedom by an administrative or court order or in an emergency setting - Any condition that in the opinion of the principal investigator (PI) would jeopardize the safety or rights of a person participating in the trial or would render the person unable to comply with the protocol.