| Eligibility |
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.
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