Study to Optimize Immune Coverage of SARS-CoV-2 Existing and Emerging Variants COVAIL Booster Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Confirmed receipt of a complete primary and booster COVID-19 vaccine series with an FDA authorized/approved vaccine at least 16 weeks prior to study vaccine dose 1
    2. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures
    3. Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health

You may not be eligible for this study if the following are true:

    1. Confirmed SARS-CoV-2 infection < 16 weeks prior to any study vaccine dose
    2. Pregnant and breastfeeding participants
    3. Prior administration of an investigational coronavirus vaccine at any time or SARS-CoV2 immunoglobulin, monoclonal antibody or plasma antibody therapy in the preceding 3 months
    4. Current/planned simultaneous participation in another interventional study or receipt of any investigational study product within 28 days prior
    5. A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine, polyethylene glycol (PEG) or nanolipid particles
    6. Received or plans to receive a vaccine within 28 days prior to or after any dose of study vaccine
    7. Bleeding disorder diagnosed by a healthcare provider
    8. Current or previous diagnosis of an immunocompromising condition or other immunosuppressive condition
    9. Advanced liver or kidney diseases
    10. Advanced (CD4 count < 200) and/or untreated HIV, untreated Hepatitis B or untreated Hepatitis C
    11. Received oral, intramuscular or intravenous systemic immunosuppressants, or immunemodifying drugs for >14 days in total within 6 months prior
    12. Received immunoglobulin or blood-derived products, within 3 months prior any study vaccine dose
    13. Received chemotherapy, immunotherapy or radiation therapy within 6 months prior to any study vaccine dose
    14. Is acutely ill or febrile 72 hours prior to or at vaccine dosing
    15. Study personnel or an immediate family member or household member of study personnel

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.