This is a Phase III, randomized, placebo-controlled, observer-blinded, parallel-group, multi-center study to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
840
injection volume of 0.5mL on Day 0
injection volume of 0.5mL on Day 0
Policlínico Social Del Norte
Bogotá, Bogota D.C., Colombia
CAIMED (Centro de Atención e Investigación Médica)
Chía, Cundinamarca, Colombia
Dhulikhel
Kathmandu, Dhulikhel, Nepal
Institute of Medicine (IOM)
Kathmandu, Maharajgunj, Nepal
GMFR (Geometric Mean Fold Rise) of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay from baseline(Visit 2) to2 weeks post heterologous booster vaccinationfor each cohort
For all cohort
Time frame: 2 weeks post heterologous booster vaccination for eachcohort
GMT of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination.
For all cohort
Time frame: Through Day 365 post vaccination
GMFR of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay from baseline (Visit 2) to each subsequent time point post heterologous booster vaccination.
For all cohort
Time frame: Through Day 365 post vaccination
Percentage of participants with ≥4-fold rise in wild-type virus neutralizing antibody titer to SARS-CoV-2 from baseline (Visit 2) to each subsequent time point post heterologous booster vaccination.
For all cohort
Time frame: Through Day 365 post vaccination
GMT of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA at each time point post heterologous booster vaccination
For all cohort
Time frame: Through Day 365 post vaccination
GMFR of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline (Visit 2) to each subsequent time point post heterologous booster vaccination
For all cohort
Time frame: Through Day 365 post vaccination
Percentage of participants with ≥4-fold rise in ELISA SARS-CoV-2 RBD-binding IgG titer from baseline (Visit 2) to each subsequent time point post heterologous booster vaccination.
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For all cohort
Time frame: Through Day 365 post vaccination
Cell-mediated response for both Th1 and Th2 cytokines measured by ELISpot and/or FluoroSpot, and for both CD4+ and CD8+ T-cells measured by FACS
For all cohort (in a subset of participants)
Time frame: Through Day 365 post vaccination
Occurrence of immediate systemic reactions in 30 minutes post heterologous booster vaccination.
For all cohort
Time frame: Through 30 minutes post booster vaccination
Occurrence of solicited local/systemic Adverse Events(AEs)
For all cohort
Time frame: Through 7 days post booster vaccination
Occurrence of unsolicited AEs
For all cohort
Time frame: Through 28 days post booster vaccination
Occurrence of SAEs, MAAEs, AEs leading to study withdrawal, and AESIs during the whole study period.
Through 7 days post booster vaccination
Time frame: Through Day 365 post booster vaccination