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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Health Index Multispecialty Clinic
Manila, Philippines
Manila Doctors Hospital
Manila, Philippines
Tropical Disease Foundation
Putatan, Philippines
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5
GMT ratio
Time frame: Day 15
To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
GMT ratio
Time frame: Day 15
Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine
Proportion of participants with local and systemic AEs
Time frame: Day 7
Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine
Proportion of participants with unsolicited AEs
Time frame: Day 29
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
Time frame: Up to 1 year post-vaccination
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
Time frame: Day 15
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
Time frame: Day 1, 15, 180
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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
Time frame: Day 1, 15, 180
Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5
SCRs
Time frame: Day 1, 15, 180
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
Time frame: Day 1, 15, 180
Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern
GMTs
Time frame: Day 1, 15
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
Time frame: Day 1, 15
Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern
SCRs
Time frame: Day 1, 15
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
Time frame: Day 1, 15