A Randomized Trial Evaluating a mRNA-VLP vaccine’s Immunogenicity and Safety for COVID-19 - ARTEMIS-C

Exclusion Criteria

• - Acute illness/infection on day prior or day of dosing
• - History of hypersensitivity to any component of the study vaccination, severe adverse reaction associated with a vaccine and/or severe allergic reaction
• - Positive COVID-19 test result within 6 months of Visit 1
• - Receipt of licensed, authorized, or investigational COVID-19 vaccines in the 6 months prior to administration of study intervention or expected receipt through completion of
• Visit 5.
• - Receipt of any COVID-19 monoclonal antibody (licensed or investigational) within 3 months or receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to administration of study intervention, or expected receipt during the study
• - Receipt of any licensed or investigational vaccine (other than licensed influenza vaccines or non-study COVID-19 vaccines) within 30 days prior to Visit 1 or expected receipt
• prior to completion of Visit 4. Licensed influenza vaccines are permitted beginning > 14 days before and > 14 days after administration of study intervention.
• - Previous history of myocarditis or pericarditis
• - Woman who are pregnant, lactating, or of child-bearing potential and not using a contraception or abstinence from at least 4 weeks prior to study vaccination and until at least 6 months after study vaccination
• - Lab values above ULN (Serum creatinine, AST, ALT), below LLN (hemoglobin, WBC, Platelet count) or any lab value that in the opinion of the investigator is clinically significant or might confound analysis of the study results. Participants with laboratory values outside of
• the normal range may have the abnormal test repeated within the screening window and if
• the values are normal, then the participant can be randomized. If the repeated value
• remains outside of the normal range but it is not felt to be clinically significant by the
• Investigator, the case can be discussed with the AstraZeneca study physician and if they
• both agree the value is not clinically significant, the participant can be randomized
• - History of malignancy within 5 years (treated non-melanoma skin cancer and locally treated cervical cancers allowed)
• - Known or suspected congenital or acquired immunodeficiency
• - Known or suspected autoimmune conditions as determined by history and /or physical examination
• - Active infection with hepatitis B or C
• - Troponin I levels above the normal range at the screening visit
• - History of hypersensitivity to kanamycin or any aminoglycoside antibiotics (eg, neomycin, streptomycin, tobramycin, and gentamicin).