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

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

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 Criteria:
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.