NCT05007951

Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19)

Completed Phase 3 Last updated 8 April 2024

What this trial tests

Phase 3 trial testing GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) in Covid19 in 4,036 participants. Completed in 2 October 2023.

Timeline

30 August 2021

Primary endpoint
2 October 2023

2 October 2023

Quick facts

Lead sponsor	SK Bioscience Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	4,036
Start date	30 August 2021
Primary completion	2 October 2023
Estimated completion	2 October 2023
Sites	38 locations across New Zealand, Ukraine, Vietnam, South Korea, Philippines, Thailand

Drugs / interventions tested

• GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) — full drug profile →
• ChAdOx1-S not less than 2.5 × 10^8 infectious units — full drug profile →
• GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose) — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

SK Bioscience Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19 vaccine development: milestones, lessons and prospects.
   Li M, Wang H, Tian L, Pang Z, et al · · 2022 · cited 298× · PMID 35504917 · DOI 10.1038/s41392-022-00996-y
2. Efficacy and safety of COVID-19 vaccines.
   Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
3. Nanotechnology's frontier in combatting infectious and inflammatory diseases: prevention and treatment.
   Huang Y, Guo X, Wu Y, Chen X, et al · · 2024 · cited 188× · PMID 38378653 · DOI 10.1038/s41392-024-01745-z
4. SARS-CoV-2 breakthrough infections elicit potent, broad, and durable neutralizing antibody responses.
   Walls AC, Sprouse KR, Bowen JE, Joshi A, et al · · 2022 · cited 178× · PMID 35123650 · DOI 10.1016/j.cell.2022.01.011
5. Targeted modulation of immune cells and tissues using engineered biomaterials.
   Yousefpour P, Ni K, Irvine DJ. · · 2023 · cited 105× · PMID 37772035 · DOI 10.1038/s44222-022-00016-2
6. A Comprehensive Review of the Protein Subunit Vaccines Against COVID-19.
   Heidary M, Kaviar VH, Shirani M, Ghanavati R, et al · · 2022 · cited 103× · PMID 35910658 · DOI 10.3389/fmicb.2022.927306
7. Current and future nanoparticle vaccines for COVID-19.
   Vu MN, Kelly HG, Kent SJ, Wheatley AK. · · 2021 · cited 65× · PMID 34801965 · DOI 10.1016/j.ebiom.2021.103699
8. Immunogenicity and safety of SARS-CoV-2 recombinant protein nanoparticle vaccine GBP510 adjuvanted with AS03: interim results of a randomised, active-controlled, observer-blinded, phase 3 trial.
   Song JY, Choi WS, Heo JY, Kim EJ, et al · · 2023 · cited 39× · PMID 37711219 · DOI 10.1016/j.eclinm.2023.102140