drugset / Trial / NCT06442241
A Safety and Immunogenicity Trial of a Respiratory Syncytial Virus Vaccine, LYB005 in Healthy Adults
Phase 1
Active not recruiting
84 enrolled
Guangzhou Patronus Biotech Co., Ltd.
Yantai Patronus Biotech Co., Ltd. · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
A phase 1, randomized, observer-blinded, parallel-controlled, dose escalation study in Australia will evaluate the safety and immunogenicity of the RSV vaccine candidate LYB005 with or without adjuvant in healthy adults aged 18 years and older.
Timeline
- Start
- 2024-07-31
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Arexvy | Vaccine | 0.5 ml | Intramuscular |
| Subject | LYB005 | Vaccine | 30 ug | Intramuscular |
| Subject | LYB005 | Vaccine | 60 ug | Intramuscular |
| Subject | LYB005 | Vaccine | 120 ug | Intramuscular |
| Subject | LYB005 | Vaccine | 0.5 ml | Intramuscular |