Pancoronavirus Vaccine Study in Healthy Adults

Exclusion Criteria

• •1. Positive SARS-CoV-2 PCR at screening.
• •2. Abnormal vital signs (Grade 1 or higher) at screening.
• •Grade 1 or higher is equivalent to:
• •Systolic blood pressure (SBP) ≥ 141 mmHg or ≤ 89 mmHg
• •Diastolic blood pressure (DBP) ≥ 91 mmHg
• •Heart rate (HR) is ≥ 101 beats per minute or ≤ 50 beats per minute
• •Oral temperature ≥ 38.0°C (100.4°F)
• •3. Body mass index (BMI) of \< 18 kilograms/square meter (kg/m\^2) or \> 35 kg/m\^2 (inclusive) at screening
• •4. History of SARS-CoV-2 infection or receipt of any COVID-19 vaccine \< 16 weeks prior to study vaccination.
• •5. Woman who is pregnant or breastfeeding.
• •6. Blood or plasma donation within 4 weeks prior to study vaccination.
• •7. Receipt of antibody or blood-derived products (except Rho D immunoglobulin) within 90 days prior to study vaccination.
• •8. Any self-reported or medically documented significant medical or psychiatric disease or condition(s) that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
• •Significant medical or psychiatric conditions include but are not limited to respiratory disease (e.g., chronic obstructive pulmonary disease \[COPD\]) requiring daily medications currently, history of asthma in the past 5 years, or any treatment of exacerbation of an underlying respiratory disease in the last 5 years. Significant kidney disease, liver disease, or cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis or pericarditis, or uncontrolled cardiac arrhythmia. Neurological or neurodevelopmental conditions (e.g., history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care, epilepsy, seizures in the last 5 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease). Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding treated basal cell and squamous cell carcinoma of the skin, which are allowed. Any autoimmune disease, including hypothyroidism without a defined non-autoimmune cause.
• •9. Has an acute illness, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
• •An acute illness that is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate subinvestigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• •10. Has known human immunodeficiency virus, hepatitis B or hepatitis C infection at screening.
• •11. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antigen or antibody at screening.
• •12. Has an ongoing symptomatic condition for which there are ongoing medical investigations, but no diagnosis or treatment plan.
• •13. Has any confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections and chronic immunosuppressant medication within the past 6 months
• •Chronic meaning more than 14 continuous days
• •14. Has taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to the first study vaccination. Intranasal, ophthalmic, or topical (skin or eyes) corticosteroids are permitted.
• •15. Has any significant disorder of coagulation requiring ongoing or intermittent treatment.
• •16. Has participated in another investigational study involving any IP within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
• •17. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccine or to the candidate vaccine components.
• •18. Receipt of inactivated/subunit vaccine within 14 days prior to vaccine administration or live vaccine within 28 days prior to vaccine administration.
• •19. Plan to receive a COVID-19 booster vaccine within the 209 days following the first study vaccination.
• •20. Planned international travel in the period between vaccination through Study Day 57 visit.
• •21. Has a history of alcohol or drug abuse within 3 years prior to study vaccination.
• •22. Has any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with participant compliance or safety evaluations.
• •23. Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
• •24. Has a history of receipt of an investigational ferritin-based vaccine.
• •25. Has any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site