drugset / Trial / NCT05007951
Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19)
Phase 3
Completed
4036 enrolled
SK Bioscience Co., Ltd.
Coalition for Epidemic Preparedness Innovations · collabGlaxoSmithKline · collabInternational Vaccine Institute · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
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.
Timeline
- Start
- 2021-08-30
- Primary completion
- 2023-10-02
- Completion
- 2023-10-02
Outcome
Met primary endpoint
paper demonstrating superiority (95% CI lower limit >1) of GBP510/AS03 PMID 37711219 ↗
paper the between-group SCR difference of 10.8% (95% CI 7.68-14.32) also satisfied the non-inferiority criterion (95% CI lower limit > -5%). PMID 37711219 ↗
Publications
- Song JY, Choi WS, Heo JY, Kim EJ, Lee JS, Jung DS, Kim SW, Park KH, Eom JS, Jeong SJ, Lee J, Kwon KT, Choi HJ, Sohn JW, Kim YK, Yoo BW, Jang IJ, Capeding MZ, Roman F, Breuer T, Wysocki P, Carter L, Sahastrabuddhe S, Song M, D'Cor N, Kim H, Ryu JH, Lee SJ, Park YW, Cheong HJ; GBP510/AS03 study group. 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. EClinicalMedicine. 2023 Sep 7;64:102140. doi: 10.1016/j.eclinm.2023.102140. eCollection 2023 Oct.
- Walls AC, VanBlargan LA, Wu K, Choi A, Navarro MJ, Lee D, Avena L, Berrueta DM, Pham MN, Elbashir S, Kraft JC, Miranda MC, Kepl E, Johnson M, Blackstone A, Sprouse K, Fiala B, O'Connor MA, Brunette N, Arunachalam PS, Shirreff L, Rogers K, Carter L, Fuller DH, Villinger F, Pulendran B, Diamond MS, Edwards DK, King NP, Veesler D. Distinct sensitivities to SARS-CoV-2 variants in vaccinated humans and mice. Cell Rep. 2022 Aug 30;40(9):111299. doi: 10.1016/j.celrep.2022.111299. Epub 2022 Aug 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ChAdOx1-S | Vaccine | 2.5e+08 iu | — |
| Subject | GBP510 | Vaccine | 25 ug | — |