| Eligibility |
Inclusion Criteria
A participant must meet all the following criteria to be eligible for the study:
- Adults ages 18 years and older.
- Judged by the investigator to be healthy based on participant-reported medical
history, physical examination, vital signs, and laboratory assessment.
- Able to provide written informed consent.
- Willing to disclose prior COVID-19 vaccination status.
- Willing to disclose prior participant-reported SARS-CoV-2 infection status.
- Prior receipt of at least 3 injections with a COVID-19 mRNA vaccine with the most
recent dose at least 6 months prior to enrollment.
- Willing to comply with all study procedures during the follow-up period of
approximately 12 or 24 months, depending on number of doses received.
- Body mass index of = 40 kg/m2 within 30 days prior to enrollment
- Electrocardiogram (ECG) without clinically significant abnormalities. Laboratory
Criteria within 30 days before enrollment
- White blood cells (WBC) and differential within institutional normal range or
accompanied by the site Principal Investigator (PI) or designee approval.
- Total lymphocyte count = 800 cells/µL.
- Platelets between 125,000 and 500,000 cells/µL.
- Hemoglobin within institutional normal range or accompanied by the PI or designee
approval.
- Alanine aminotransferase (ALT) = 1.25 x institutional upper limit of normal (ULN).
- Aspartate aminotransferase (AST) = 1.25 x institutional ULN.
- Serum creatinine = 1.1 x institutional ULN.
- Ferritin, iron and TIBC within institutional normal range or accompanied by the PI or
designee approval.
For participants of childbearing potential:
- Negative beta-human chorionic gonadotropin (ß-HCG) pregnancy test (urine or serum) on
the day of enrollment.
- Must agree to avoid pregnancy from 21 days prior to study Day 1 until at least 90 days
after last study vaccination.
Exclusion Criteria
A participant will be excluded if one or more of the following conditions apply:
- Known SARS-CoV-2 infection or positive test result within 6 months prior to Day 1.
- Ongoing prophylactic COVID-19 treatment, or monoclonal antibody infusion within 6
months prior to Day 1.
- Any COVID-19 vaccination within 6 months prior to Day 1.
- Exhibits symptoms consistent with COVID-19 as assessed by study clinician such as:
fever, dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia,
diarrhea, shortness of breath or dyspnea within 14 days prior to in Day 1.
- Known close contact (as defined by CDC, 2021a) with someone who has COVID-19 within 14
days prior to Day 1.
- History or presence of self-reported or medically documented significant medical or
psychiatric condition(s) as assessed by study clinician, including:
- At high risk of severe COVID-19 disease, such as significant history of COPD or
chronic lung disease, chronic kidney disease, serious heart conditions (such as heart
failure, coronary artery disease or cardiomyopathies), sickle cell disease, diabetes.
- Clinically significant central nervous system disease such as epilepsy,
encephalopathy, or a history of severe mental illness.
- Severe liver and/or kidney diseases, uncontrolled hypertension, or ongoing or highly
likely to recur malignancies.
- Ongoing or recent clinically significant history of alcohol or drug abuse.
- Current participation in an interventional clinical study with an investigational
drug/biologic/device agent or receipt of any investigational agent within 30 days
prior to Day 1.
- Evidence of infection with human immunodeficiency virus (HIV), hepatitis B virus, or
hepatitis C virus.
- History of myocarditis or pericarditis.
- Diagnosed with congenital or acquired immune deficiency, ongoing lymphoma, leukemia,
or other clinically significant immune compromising or autoimmune conditions.
- History of known coagulation dysfunction (e.g., coagulation factor deficiency, known
thrombocytopenia, platelet dysfunction, coagulation disease, etc.).
- Receipt of any live attenuated vaccine within 30 days, or with any other (non-live)
vaccine within 14 days prior to Day 1.
- Received more than 10 days of any systemic immunosuppressants or cytotoxic medications
within 30 days prior to Day 1, any within 14 days prior to Day 1 or is anticipating
the need for immunosuppressants at any time during participation in the study.
- Received any blood products within 3 months prior to Day 1.
- Donated > 450 mL of whole blood within 30 days prior to Day 1.
- History of unexplained or recurrent anaphylaxis or angioedema, or a history of severe
allergic reaction (e.g., anaphylaxis) after a previous dose of any vaccine, or to any
component of the study vaccine.
- For participants of childbearing potential: breastfeeding or planning to become
pregnant during trial duration.
- Any condition that, in the opinion of the investigator, would (a) pose a health risk
to the participant if enrolled or (b) could interfere with evaluation of the study
vaccine or interpretation of study results.
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