• Any clinically significant abnormality or vital sign abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening
• any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject's participation
• an active COVID-19 infection (positive COVID-19 test: nasal/oropharyngeal swab and/or positive serum antibody response) at screening, or Day 1, or has been in close contact with someone who has an active COVID-19 infection, or has recovered from a previous COVID-19, SARS-CoV-1, or MERS infection
• Positive pregnancy, urine drug screen, or alcohol breath test at screening
• Known history of allergic reactions or hypersensitivity to vaccines, or to any excipient in the formulation (including the adjuvant, MF59C.1)
• Presence of a known, or suspected, impairment of the immune system including, but not limited to, HIV, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus
• History of a known, or suspected, respiratory system disorder including, but not limited to, cystic fibrosis, reactive airway disease, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (COPD), or asthma, excluding childhood asthma
• History of significant alcohol abuse within 12 months prior to screening
• Positive test for drugs of abuse or a history of drug abuse within 12 months prior to screening
• Participation in a clinical research study involving the administration of an investigational, or marketed, drug or device within 30 days prior to receiving the first treatment
• Use of medications: Prescription medication within 14 days prior to the first dosing
• Any medication, or treatments, that may affect the immune system
• Any registered vaccine administered within 30 days prior to enrolment in the study, or who plan to receive any non-study vaccines within 28 days of the second dose of the study vaccine
• Any other investigational coronavirus vaccine i.e. SARS-CoV-1, SARS-CoV-2, MERS etc. at any time prior to, or during, the study
• Over-the-counter products within 7 days prior to the first dosing
• Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing
• Receipt of blood products within 2 months prior to the first study treatment administration (Day 1), or planned receipt of blood products during the study period
• Breast-feeding subject, or subject who plans to breastfeed from the time of first dose through 60 days after last study treatment administration
• Presence of tattoos, scarring, skin discoloration, or any other skin disturbances at the injection site which, in the opinion of the Investigator, may inhibit the ability to effectively perform an injection site assessment
• Employee or immediate relative of an employee of the clinical site, any of its affiliates or partners, or Syneos Health
• Any reason which, in the opinion of the Investigator, would interfere with the primary study objectives or prevent the subject from participating in the study.

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, Immediately after publication with no end date.
Data accessibility: Requests for access can be made via correspondence to A/Prof Keith Chappell, k.chappell@uq.edu.au.