This is a 2-Stage, Phase III, randomized, active-controlled, observer-blind, parallel-group, multi-center study to compare the immunogenicity and safety of SK SARS-CoV-2 recombinant nanoparticle vaccine adjuvanted with AS03 (GBP510) to ChAdOx1-S in adults aged 18 years and older.
The purpose of this study is to assess the immunogenicity and safety of SK SARS-CoV-2 recombinant nanoparticle vaccine adjuvanted with AS03 (GBP510) in adults aged 18 years and older. This study includes 2-dose schedule (28-day interval) of GBP510(Test vaccine) and ChAdOx1-S(Control vaccine) in stage1. Participants are expected to participate for up to a maximum of approximately 13 months. A 12-month study follow-up after the 2nd vaccination will be conducted. One booster dose of GBP510 is scheduled for both test group and control group in Stage2. A 12-month study follow-up after the 3rd vaccination will be conducted. International Vaccine Institute (IVI) conducts GBP510\_003 trial as co-sponsor with SK bioscience.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,036
injection volume of 0.5mL on days 0 and 28 (stage1)
injection volume of 0.5mL on days 0 and 28 (stage1)
injection volume of 0.5mL on days 0 (stage2)
Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
For Cohort 1
Time frame: 2 weeks post 2nd vaccination
Percentage of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline
For Cohort 1
Time frame: 2 weeks post 2nd vaccination
Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
For Cohort 3
Time frame: 2 weeks post 3rd (booster) and 2nd vaccination
GMT of SARS-CoV-2 Receptor-Binding Domain(RBD)-binding IgG antibody measured by Enzyme-Linked Immunosorbent Assay (ELISA) at each time point post-vaccination
For Cohort 1
Time frame: Through Day 365 post last vaccination
Geometric Mean Fold Rise(GMFR) of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline
For Cohort 1
Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise SARS-CoV-2 RBD-binding IgG titer from baseline
For Cohort 1
Time frame: Through Day 365 post last vaccination
GMT of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
For Cohort 1
Time frame: Through Day 365 post last vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Southern Clinicaltrials Waitemata
Auckland, New Zealand
Southern Clinical Trials Christchurch
Christchurch, New Zealand
Lakeland Clinicaltrials Waikato
Hamilton, New Zealand
Southern Clinical Trials Tasman
Nelson, New Zealand
Lakeland Clinicaltrials Culloden
Papamoa, New Zealand
Lakeland Clinicaltrials Rotorua
Rotorua, New Zealand
Lakeland Clinicaltrials Wellington
Upper Hutt, New Zealand
San Francisco Multi-Purpose Building
Manila, Philippines
University of the East-Ramon Magsaysay Memorial Medical Center Inc.
Manila, Philippines
Health Index Multispeciality Clinic
Quezon City, Philippines
...and 28 more locations
GMFR of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays from baseline
For Cohort 1
Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline
For Cohort 1
Time frame: Through Day 365 post last vaccination
Cell-mediated response for both Th1 and Th2 cytokines measured by Enzyme-Linked ImmunoSpot (ELISpot)/ FluoroSpot, and for both CD4+ and CD8+ T-cells measured by Fluorescence-activated cell sorting(FACS)
For Cohort 1
Time frame: Through Day 365 post last vaccination
Occurrence of immediate systemic reactions in the 30 minutes post each vaccination
For all Cohort
Time frame: Through 30 minutes post each vaccination
Occurrence of solicited local Adverse Events(AEs)
For all Cohort
Time frame: Through 7 days post each vaccination
Occurrence of solicited systemic AEs
For all Cohort
Time frame: Through 7 days post each vaccination
Occurrence of unsolicited AEs
For all Cohort
Time frame: Through 28 days post each vaccination
Occurrence of Serious Adverse events(SAEs), Medically attended Adverse Events(MAAEs), AEs leading to study withdrawal, and Adverse Events of Special Interests(AESIs)
For all Cohort
Time frame: Through Day 365 post last vaccination
GMTs of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
For Cohort 3
Time frame: 2 weeks post 3rd (booster) and 2nd vaccination
Percentages of participants with ≥ 4-fold rise in wild-type virus neutralizing antibody titer from baseline (Visit 2)
For Cohort 3
Time frame: 2 weeks post 3rd (booster) and 2nd vaccination
GMTs of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays
For Cohort 3
Time frame: pre (Visit 1B) and 2 weeks post 3rd (booster) vaccination
GMTs of neutralizing antibody to the SARS-CoV-2 measured by neutralization assays
For Cohort 3
Time frame: 2 weeks post 3rd (booster) and 2nd vaccination
GMT of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA at each time point post booster vaccination
For Cohort 3
Time frame: Through Day 365 post last vaccination
GMFR of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline (Visit 2) to each subsequent time point post booster vaccination
For Cohort 3
Time frame: Through Day 365 post last vaccination
GMFR of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from prior to booster vaccination (Visit 1B) to each subsequent time point post booster vaccination
For Cohort 3
Time frame: Through Day 365 post last 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 booster vaccination
For Cohort 3
Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥4-fold rise in ELISA SARS-CoV-2 RBD-binding IgG titer from pre-booster vaccination (Visit 1B) to each subsequent time point post booster vaccination
For Cohort 3
Time frame: Through Day 365 post last vaccination
GMT of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post booster vaccination
For Cohort 3
Time frame: Through Day 365 post last 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 booster vaccination.
For Cohort 3
Time frame: Through Day 365 post last vaccination
GMFR of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay from prior to booster vaccination (Visit 1B) to each subsequent time point post booster vaccination
For Cohort 3
Time frame: Through Day 365 post last 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 booster vaccination.
For Cohort 3
Time frame: Through Day 365 post last vaccination
Percentage of participants with ≥4-fold rise in wild-type virus neutralizing antibody titer to SARS-CoV-2 from pre-booster vaccination (Visit 1B) to each subsequent time point post booster vaccination
For Cohort 3
Time frame: Through Day 365 post last vaccination
Cell-mediated response for both Th1 and Th2 cytokines (including but not limited to INF-γ, TNF-α, IL-2, and IL-4 produced by T lymphocytes) measured by ELISpot and/or FluoroSpot, and for both CD4+ and CD8+ T-cells measured by FACS
For Cohort 3
Time frame: Through Day 365 post last vaccination