Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine

Inclusion Criteria

A subject must meet all of the following criteria to be eligible to participate in this study:

• Provides written informed consent prior to initiation of any study procedures.
• Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
• Agrees to the collection of venous blood per protocol.
• Confirms to have not donated blood three months before the study
• Agrees to refrain from blood during the study and until the three months after the end of the study.
• Body Mass Index 18-29 kg/m2, inclusive, at screening.
• Premenopausal women must agree to use one acceptable primary form of contraception.
• Premenopausal women must have a negative urine pregnancy test the day of vaccination and are routinely using - and willing to use up to six months from vaccine administration - an effective method of birth control resulting in a low failure rate (i.e., hormonal contraception, condoms in combination with a spermicidal cream, male partner sterilization-vasectomy or total sexual abstinence).
• Oral temperature ≤37.0 degrees Celsius the day of the administration of the vaccine
• Pulse no greater than 100 beats per minute.
• Systolic blood pressure (BP) is 85 to 139 mmHg, inclusive the day of vaccination.
• Should not show laboratory values outside the normal range which may have clinical significance even in absence of specific signs or symptoms.

Exclusion Criteria

A subject who meets any of the following criteria will be excluded from participation in this study:

• Positive serology for anti-HIV-Ab
• Positive HbBsAg
• Positive anti-HCV-Ab
• Positive for SARS-CoV-2 (either anti-S-Ab or anti-N-Ab)
• Acute illness, as determined by the site PI or appropriate sub-investigator, the day of vaccination.
• Breastfeeding women
• Autoimmune and hyper-inflammatory condition
• History of atopy (or any IgE associated condition) who had required treatment over the last 6 months;
• History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines;
• Assumption of any immunomodulatory medication over the last 4 months (including, but not limited to, systemic corticosteroids, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs). The use of low dose topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted.
• Presence of self-reported or medically documented significant medical condition
• Presence of self-reported or medically documented significant psychiatric condition
• Significant cardiovascular disease needing therapy or history of myocarditis or pericarditis or heart surgery. Patients in treatment with Sartans or ACE-Inhibitors and good response to therapy may be included.
• Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
• Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
• Primary or secondary immunodeficiency of any cause.
• Participated in another investigational study involving vaccination of biologic compounds in the last 12 months.
• Currently enrolled in or plans to participate in another clinical trial with an investigational agent that will be received during the study-reporting period.
• Administration of immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study.
• Has any significant disorder of coagulation.
• Has any chronic liver disease, including fatty liver.
• Has a history of alcohol abuse or other recre