Phase 3 Boosting Study for the SARS-CoV-2 rS Vaccine

Exclusion Criteria

• •1. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.
• •2. Has previously received a primary series vaccination or booster dose of any COVID- 19 vaccine other than BBIBP-CorV.
• •3. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine (including COVID-19) within 30 days prior to first study vaccination.
• •4. Any known allergies to products contained in the investigational product
• •5. Any history of anaphylaxis to any prior vaccine.
• •6. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy. NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis), including stable diabetes mellitus with no history of diabetic ketoacidosis are NOT excluded.
• •7. Chronic administration (defined as \> 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination. NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose
• •≥ 10 mg of prednisone per day or equivalent. The use of topical or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.
• •Use of inhaled glucocorticoids is prohibited.
• •8. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
• •9. Active cancer (malignancy) on therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
• •10. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
• •11. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
• •12. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
• •13. Study team member or immediate family member of any study team member (inclusive of Sponsor, CRO, and study site personnel involved in the conduct or planning of the study)