Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults
Phase 3
Withdrawn
- Conditions
- COVID-19
- Registration Number
- NCT05926440
- Lead Sponsor
- Clover Biopharmaceuticals AUS Pty Ltd
- Brief Summary
The purpose of this study is to assess the immunogenicity and safety of SCB-2023 trivalent vaccine compared to the prototype SCB-2019 monovalent vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine Up to 1 year post-vaccination Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5 Day 15 GMT ratio
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5 Day 15 GMT ratio
Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine Day 7 Proportion of participants with local and systemic AEs
- Secondary Outcome Measures
Name Time Method Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 Day 1, 15, 180 GMFRs
Non-inferiority with respect to ratio of the geometric mean of Omicron BA.5 titer in SCB-2023 recipients and SARS-CoV-2 Delta titers in SCB-2019 recipients, as measured by virus neutralization assay. Day 15 GMT ratio
Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5. Day 1, 15, 180 GMTs; GMFRs; SCRs; Proportion of participants with antibody titer ≥ LLoQ
Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern Day 1, 15 GMTs
Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against SARS-CoV-2 variants of concern Day 1, 15 GMFRs
Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 Day 1, 15, 180 SCRs
Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern Day 1, 15 SCRs
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 Day 1, 15, 180 Proportion of participants with antibody titer ≥ LLoQ
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against SARS-CoV-2 variants of concern Day 1, 15 Proportion of participants with antibody titer ≥ LLoQ
Trial Locations
- Locations (3)
Health Index Multispecialty Clinic
🇵🇭Manila, Philippines
Manila Doctors Hospital
🇵🇭Manila, Philippines
Tropical Disease Foundation
🇵🇭Putatan, Philippines
Health Index Multispecialty Clinic🇵🇭Manila, Philippines