drugset / Trial / NCT05396573
A Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19
Phase 1
Unknown
120 enrolled
Walvax Biotechnology Co., Ltd.
Shanghai RNACure Biopharma Co., Ltd. · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This is a phase 1b, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013 in healthy adults primed with a two-dose inactivated vaccine 6-9 months earlier. The study vaccine is administered IM in the upper arm deltoid as single booster shot on day 0.
Timeline
- Start
- 2022-07
- Primary completion
- 2022-08
- Completion
- 2023-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BNT162b2 | Messenger RNA (mRNA) | 30 ug | — |
| Subject | RQ3013 | Messenger RNA (mRNA) | 30 ug | Intramuscular |
| Subject | RQ3013 | Messenger RNA (mRNA) | 60 ug | Intramuscular |