COVID-19 Clinical Trial
Official title:
Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of SCB-2023 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine
Verified date | August 2023 |
Source | Clover Biopharmaceuticals AUS Pty Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 17, 2023 |
Est. primary completion date | August 17, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Philippines | Health Index Multispecialty Clinic | Manila | |
Philippines | Manila Doctors Hospital | Manila | |
Philippines | Tropical Disease Foundation | Putatan |
Lead Sponsor | Collaborator |
---|---|
Clover Biopharmaceuticals AUS Pty Ltd |
Philippines,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5 | GMT ratio | Day 15 | |
Primary | To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5 | GMT ratio | Day 15 | |
Primary | Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine | Proportion of participants with local and systemic AEs | Day 7 | |
Primary | Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine | Proportion of participants with unsolicited AEs | Day 29 | |
Primary | Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine | Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs | Up to 1 year post-vaccination | |
Secondary | 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. | GMT ratio | Day 15 | |
Secondary | Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5. | GMTs; GMFRs; SCRs; Proportion of participants with antibody titer = LLoQ | Day 1, 15, 180 | |
Secondary | 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 | GMFRs | Day 1, 15, 180 | |
Secondary | Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 | SCRs | Day 1, 15, 180 | |
Secondary | Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 | Proportion of participants with antibody titer = LLoQ | Day 1, 15, 180 | |
Secondary | Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern | GMTs | Day 1, 15 | |
Secondary | Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against SARS-CoV-2 variants of concern | GMFRs | Day 1, 15 | |
Secondary | Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern | SCRs | Day 1, 15 | |
Secondary | Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against SARS-CoV-2 variants of concern | Proportion of participants with antibody titer = LLoQ | Day 1, 15 |
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