Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study (ACT)
Covid19
About this trial
This is an interventional prevention trial for Covid19 focused on measuring vaccine, safety, immunogenicity, dose-finding, exploratory efficacy
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.
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
AKS-452 s.c.(A)
AKS-452 s.c. (B)
AKS-452 s.c. (C)
AKS-452 s.c. (D)
AKS-452 s.c. (E)
AKS-452 s.c. (F)
Phase 2, single-dose injection
Phase 2, two-dose injection
Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL) single-dose
Subcutaneous injection of pre-defined dose (22,5 ug, 125 uL), two-dose
Subcutaneous injection of pre-defined dose (45 ug, 205 uL), single-dose
Subcutaneous injection of pre-defined dose (45 ug, 250 uL), two-dose
Subcutaneous injection of pre-defined dose (90 ug, 500 uL), single-dose
Subcutaneous injection of pre-defined dose (90 ug, 500 uL), two-dose
Subcutaneous injection of selected dose based on phase 1 data, dose (90 ug, 500 uL)
Subcutaneous injection of selected dose based on phase 1 data, dose (45 ug, 500 uL) twice.