Drugs / GBP510
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04750343 | Feb → Jul 2021 | — | SK Bioscience Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT04742738 | Jan → Jul 2021 | — | SK Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05175950 | Jan 2022 → Aug 2023 | — | Korea University Guro Hospital | Unknown | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05501522 | Dec 2022 → Aug 2023 | COVID-19 | SK Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05007951 | Aug 2021 → Oct 2023 | COVID-19 | SK Bioscience Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2022-04-29 | SK Bioscience Co., Ltd. | Results SK bioscience and GSK’s Adjuvanted COVID-19 Vaccine Candidate Meets Coprimary Objectives in a Phase III Study; Biologics License Application Submitted for SKYCovione™(GBP510/GSK adjuvant) in South Korea skbioscience.com ↗
The results of the Phase III clinical trial show a superior neutralizing antibody response of SKYCovione™ against SARS-CoV-2 parental strain, 2.93 times that of a control vaccine 2 weeks after the second dose. |
| 2022-04-29 | GlaxoSmithKline | Results SK bioscience and GSK’s adjuvanted COVID-19 vaccine candidate meets coprimary objectives in a phase III study; Biologics License Application submitted for SKYCovione™(GBP510/GSK adjuvant) in South Korea gsk.com ↗
The results of the Phase III clinical trial show a superior neutralizing antibody response of SKYCovione™ against SARS-CoV-2 parental strain, 2.93 times that of a control vaccine 2 weeks after the second dose. |
| 2022-04-25 | SK Bioscience Co., Ltd. | Results SK bioscience Reports Positive Phase III Immunogenicity Results of Its Adjuvanted Covid-19 Vaccine Clinical Trial of COVID-19 Vaccine, AS03-adjuvanted skbioscience.com ↗
SK bioscience announced that the candidate vaccine is non-inferior to AstraZeneca´s COVID-19 vaccine, Vaxzevria (control vaccine) in immunogenicity when injected twice with an interval of 4 weeks. |
| 2022-03-22 | SK Bioscience Co., Ltd. | Regulatory SK bioscience Announces Commencement of Booster Trial of Adjuvanted COVID-19 Vaccine Candidate ‘GBP510(AS03)’ in South Korea skbioscience.com ↗
SK bioscience announced that the company has submitted an investigational new drug (IND) application for a homologous booster trial of ´GBP510, a COVID-19 vaccine candidate to South Korea’s Ministry of Food and Drug Safety (KMFDS). |
| 2021-11-05 | SK Bioscience Co., Ltd. | Results SK bioscience Announces Positive Data from Phase I/II Clinical Trial of COVID-19 Vaccine Candidate skbioscience.com ↗
As a result, the generation of the neutralizing antibodies against the COVID-19 virus has been confirmed in all participants receiving the adjuvanted vaccine, demonstrating a 99% seroconversion rate. |
| 2021-06-28 | SK Bioscience Co., Ltd. | Regulatory SK Bioscience Submits Phase III IND for COVID-19 Vaccine skbioscience.com ↗
GBP510, a COVID-19 vaccine candidate was submitted an IND for a Phase III clinical study in Korea and extend to international studies |
| 2020-12-10 | SK Bioscience Co., Ltd. | Regulatory SK bioscience’s COVID-19 Vaccine Candidate Is Chosen to First ‘Wave2’ Supporting Candidate skbioscience.com ↗
SK bioscience submitted an application for Investigational New Drug (IND)of GBP510 to the Ministry of Food and Drug Safety(KMFDS) on the 9th. |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GBP510 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05175950 ↗ |
| Modality | Vaccine | “SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510)” NCT04742738 ↗ |
| Route | Intramuscular | “Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.” NCT04742738 ↗ |