A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Exclusion Criteria

• •1. Positive SARS-CoV-2 PCR at screening.
• •2. Abnormal vital signs (Grade 1 or higher):
• •\*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 \</= 54 beats per minute Oral temperature \>/= 38.0 degrees Celsius (100.4 degrees Fahrenheit)
• •3. Self-reported or medically documented SARS-CoV-2 infection (regardless of whether symptomatic or asymptomatic) within 16 weeks prior to study product administration.
• •4. Participant who is pregnant or breastfeeding.
• •5. Blood or plasma donation within 4 weeks before study product administration.
• •6. Receipt of antibody or blood-derived products within 90 days before study product administration.
• •7. Any self-reported or documented significant medical or psychiatric diseases\* or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
• •\*Significant medical or psychiatric conditions include but are not limited to drug or alcohol abuse within 6 months of enrollment, significant kidney disease, liver disease, ongoing malignancy, or recent diagnosis of malignancy in the last five years, excluding treated basal and squamous cell carcinoma of the skin and cervical carcinoma in situ, which are allowed.
• •8. Neurological conditions\*. \*Including 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.
• •9. History of significant respiratory disease currently requiring daily medications, history of asthma in the past 5 years, or any treatment of respiratory disease exacerbations in the last 5 years.
• •10. History of cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis, pericarditis, or uncontrolled cardiac arrhythmia.
• •11. Any autoimmune disease, including hypothyroidism, without a defined non-autoimmune cause.
• •12. Has an acute illness determined by the site PI or appropriate sub-investigator within 72 hours before study product administration\*.
• •\*An acute illness that is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• •13. Has a positive test result for hepatitis B surface antigen, hepatitis C virus RNA (by reflex testing), or human immunodeficiency virus (HIV) antigen/antibody test at screening.
• •14. 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 means more than 14 continuous days.
• •\*\*Ophthalmic and topical steroids are allowed.
• •15. Has received any investigational study product within 60 days, or 5 half-lives, whichever is longer, before study product administration or is planning to receive one during the study.
• •16. Has a history of hypersensitivity or severe allergic reaction\* to any previous licensed or unlicensed study products or the candidate study product components\*\*.
• •\*(e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction)
• •\*\*See IB for study product formulation.
• •17. Received or plans to receive licensed inactivated/subunit vaccine within 14 days of study product administration or live vaccine within 28 days of study product administration.
• •18. Plan to receive a COVID-19 booster vaccine within the 180 days following study product administration.
• •19. Regular use of intranasal medications, including steroids, and sinus rinsing treatments\*.
• •\*Participants must have had no intranasal medication use for 30 days before study product administration and do not plan to use intranasal medications for 30 days after study product administration for medications other than steroids and for 6 months after study product administration for intranasal steroids (including over-the-counter (OTC) fluticasone).Participants should not use nasal irrigation or sinus rinsing treatments (e.g., Neti pots or saline washes) for 28 days after the study product administration and 7 days before study visits for the duration of the trial.
• •20. Use of illicit intranasal drugs in the 5 years before study product administration or plans to use during the study.
• •21. Current smoker (including cigarettes, marijuana, and vaping) or smoking within the prior 3 months.
• •22. Planned international travel between product administration and Day 29 visit.
• •23. Any significant nasal or upper airway disease\*. \*Including, but not limited to, being prone to epistaxis, has a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear implants, head/neck radiation history, anosmia/dysosmia, and certain ear, nose and throat (ENT) conditions, including major anatomic nasopharyngeal abnormality or sinus polyp disease due to chronic sinusitis.