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A 2-Stage, Phase I/II, Placebo-controlled, Randomized, Observer-blinded, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 in Healthy Younger and Older Adults
This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded, age-escalating study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with or without AS03 in healthy younger and older adults.
Details
| Lead sponsor | SK Bioscience Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 328 |
| Start date | 2021-02-03 |
| Completion | 2022-06 |
Conditions
- COVID-19 (Healthy Volunteers)
Interventions
- GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 1
- GBP510 (RBD 10μg/dose) - Stage 1
- Normal saline (0.9% sodium chloride solution) - Stage 1
- GBP510 adjuvanted with AS03 (RBD 25μg/dose) - Stage 1
- GBP510 (RBD 25μg/dose) - Stage 1
- Normal saline (0.9% sodium chloride solution) - Stage 1
- GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 2
- GBP510 adjuvanted with AS03 (RBD 25μg/dose)- Stage 2
- GBP510 (RBD 25μg/dose)- Stage 2
- Normal saline (0.9% sodium chloride solution)- Stage 2
Primary outcomes
- Occurrence of immediate systemic reactions - Stage 1 — Through 30 minutes (2 hours for sentinel participants) post-vaccination
- Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1 — Through 7 days post-vaccination
- Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1 — Through 7 days post-vaccination
- Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1 — Through 28 days post-vaccination
- Occurrence of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs) during the whole study period - Stage 1 — Through Day 0 to Day 365 post last vaccination
- (Only in Sentinel group) Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) during 7 days post 1st vaccination - Stage 1 — Through 7 days post 1st vaccination
Countries
South Korea