Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults

Launched by CLOVER BIOPHARMACEUTICALS AUS PTY · Jun 21, 2023

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female ≥18 years of age.
• • Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
• • Individuals willing and able to give an informed consent, prior to screening.
• • Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
• • Individuals who received three doses of inactivated COVID-19 vaccine.
• Exclusion Criteria:
• • Body temperature \>37.8°C (axillary), or any acute illness at baseline.
• • Confirmed SARS-CoV-2 infectionor with known history of COVID-19.
• • Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
• • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
• • Any progressive unstable or uncontrolled clinical conditions.
• • Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
• • History of severe adverse reaction associated with a vaccine or severe allergic reaction.
• • History of malignancy within 1 year before screening.
• • Individuals who have received any other investigational product.
• • Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
• • Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
• • Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
• • Administration of intravenous immunoglobulins and/or any blood products.
• • Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.