Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults and Boost (VXA-CoV2-1.1-S) at 1 Year Post Initial Vaccination in Subset of Subjects

1. Known previous exposure to SARS-CoV-2 or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).

2. Is in a current occupation with high risk of exposure to SARS-CoV-2

3. Individuals with the following underlying medical conditions who are at higher risk (or might be at higher risk) of severe illness from COVID-19 per the CDC's guidance

4. Donation or use of blood or blood products within 4 weeks prior to vaccination or planned donation during the study period.

5. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.

6. Any condition that resulted in the absence or removal of the spleen.

7. Positive HIV, HBsAg or HCV tests at the screening visit.

8. Stool sample with occult blood at screening.

9. Use of antiviral medications, including anti-retrovirals, or any prescriptive medications for the prevention of COVID-19 within 7 days before vaccination

10. Use of antibiotics, proton pump inhibitors, H2 blockers or antacids or medications known to affect the immune function within 7 to 14 days before vaccination

11. Regular use of nonsteroidal anti-inflammatory drugs, sulfonylureas, and angiotensin II blockers within 7 days before vaccination

12. Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness

13. History of drug, alcohol or chemical abuse within 1 year of screening or positive urine drug screen for drugs of abuse at screening

14. History of hypersensitivity or allergic reaction to any component of the investigational vaccine

15. Administration of any investigational vaccine, drug or device within 8 weeks preceding vaccination

16. Any other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a subject participating in the trial, would render the subject unable to comply with the protocol or would interfere with the evaluation of the study endpoints.

For subjects being re-evaluated for participation in the VXA-CoV2-1.1-S boost substudy the following will also be exclusionary:

17. Laboratory values outside the range of normal for platelet counts and the following coagulation tests: PT/INR, aPTT, fibrinogen, and D-dimer.

18. Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:

e. Family or personal history of bleeding or thrombosis f. History of heparin-related thrombotic events, and/or receiving heparin treatments g. History of autoimmune or inflammatory disease h. Presence of any of the following conditions known to increase risk of thrombosis within 6 months prior to screening:

* Recent surgery other than removal/biopsy of cutaneous lesions

* Immobility (confined to bed or wheelchair for 3 or more successive days)

* Head trauma with loss of consciousness or documented brain injury

* Receipt of anticoagulants for prophylaxis of thrombosis

* Recent clinically significant infection

What this study is about