Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years

Exclusion Criteria

• •1. Participant is pregnant or planning to become pregnant within 3 months after last study vaccine administration.
• •2. History of allergy to any component of the vaccine.
• •3. History of laboratory-confirmed SARS-CoV infection
• •4. Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30 days prior to screening.
• •5. Participant has participated in a clinical study involving an investigational SARS-CoV-2 vaccine or has received or plans to receive a licensed SARS-CoV-2 vaccine during the duration of the study.
• •6. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever \> 100 °F (\> 37.8 °C) 48 hours before vaccination.
• •7. Participant has a known or suspected defect of the immune system, such as participants with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to the expected day of randomization.
• •8. Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the participant may be enrolled.
• •9. History of drug dependency or current use of drug of abuse or alcohol abuse at screening.
• •10. Significant blood loss (\> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to the expected day of first vaccination or the booster administration.
• •11. History of clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
• •12. Severe and uncontrolled ongoing autoimmune or inflammatory disease, history of Guillain-Barre syndrome or any other demyelinating condition.
• •13. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study.
• •Prior/concomitant therapy:
• •14. Receipt of immunoglobulin or another blood product within the 3 months before expected day of first vaccination or the booster administration in this study or those who expect to receive immunoglobulin or another blood product during this study.
• •15. Receipt of medications and or vaccinations intended to prevent COVID-19.
• •16. Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine or for medical emergencies such as tetanus or rabies exporsure, within 28 days prior to the expected day of randomization.
• •Others:
• •17. Any member of the study team or sponsor.
• •18. An immediate family member or household member of the study's personnel.
• •Booster Vaccination in participants 56 years and older:
• •In addition to the above described eligibility criteria, the following criteria must be met:
• •1\. Participant has not received a licensed COVID-19 vaccine during his/her participation in the study.