drugset / Trial / NCT04487210
A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19
Non-randomizedSequentialOpen-labelPrevention
Summary
This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901.
Timeline
- Start
- 2020-10-07
- Primary completion
- 2021-06-01
- Completion
- 2021-12-06
Publications
- Hsieh SM, Chang SC, Cheng HY, Shih SR, Lien CE. Durability and Immunogenicity of Neutralizing Antibodies Response Against Omicron Variants After Three Doses of Subunit SARS-CoV-2 Vaccine MVC-COV1901: An Extension to an Open-Label, Dose-Escalation Phase 1 Study. Infect Dis Ther. 2022 Aug;11(4):1493-1504. doi: 10.1007/s40121-022-00652-6. Epub 2022 May 17.
- Hsieh SM, Liu WD, Huang YS, Lin YJ, Hsieh EF, Lian WC, Chen C, Janssen R, Shih SR, Huang CG, Tai IC, Chang SC. Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC-COV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study. EClinicalMedicine. 2021 Aug;38:100989. doi: 10.1016/j.eclinm.2021.100989. Epub 2021 Jun 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MVC-COV1901 | Vaccine | 5 ug | Intramuscular |
| Subject | MVC-COV1901 | Vaccine | 15 ug | Intramuscular |
| Subject | MVC-COV1901 | Vaccine | 25 ug | Intramuscular |