drugset / Trial / NCT06680128
A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults
RandomizedSequentialQuadruple-blindPrevention
Summary
This is a 2-Stage, Phase I/II Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis mRNA Vaccines (GBP560) in Healthy Adults (Aged 18 Years and Older)
Timeline
- Start
- 2025-02-24
- Primary completion
- 2026-07-31
- Completion
- 2026-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GBP560-A | Messenger RNA (mRNA) | 3 ug | Intramuscular |
| Subject | GBP560-A | Messenger RNA (mRNA) | 15 ug | Intramuscular |
| Subject | GBP560-A | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | GBP560-B | Messenger RNA (mRNA) | 3 ug | Intramuscular |
| Subject | GBP560-B | Messenger RNA (mRNA) | 15 ug | Intramuscular |
| Subject | GBP560-B | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Comparator | IC51 | Vaccine | 6 unknown | — |
| Comparator | IMOJEV | Vaccine | 4 unknown | — |
| Comparator | IMOJEV | Vaccine | 5.8 unknown | — |