drugset / Trial / NCT05907044
A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults
Completed
376 enrolled
Affiliated Hospital of Yunnan University
Kunming Medical University · collabYunnan University · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are: * The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013 against the current SARS-CoV-2 circulating variant. * The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19 vaccine-experienced participants 18 through 55 years of age. * Explore the protective efficacy by documenting confirmed COVID-19 cases after vaccination.
Timeline
- Start
- 2023-05-08
- Primary completion
- 2023-06-10
- Completion
- 2023-11-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | RQ3013 | Messenger RNA (mRNA) | 30 ug | — |
| Comparator | RQ3013 | Messenger RNA (mRNA) | 0.15 ml | — |
| Subject | RQ3025 | Messenger RNA (mRNA) | 30 ug | — |
| Subject | RQ3025 | Messenger RNA (mRNA) | 0.15 ml | — |
| Subject | RQ3027 | Messenger RNA (mRNA) | 30 ug | — |
| Subject | RQ3027 | Messenger RNA (mRNA) | 0.15 ml | — |