drugset / Trial / NCT05050474
Booster Immunization Study of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)
Phase 1
Completed
43 enrolled
Livzon Pharmaceutical Group Inc.
Guangdong Center for Disease Prevention and Control · collabSimoon Record Pharma Information Consulting Co., Ltd. · collab
NaSingle-groupOpen-labelPrevention
Summary
This study is a continuation study of the original V-01-I phase trial, using a single-center, single-arm, open design to evaluate the immunogenicity and safety of the third dose booster immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in healthy participants immunized with two doses schedule of V-01. The primary objective is to evaluate the Immunogenicity of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01. The secondary objective is to evaluate the safety of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.
Timeline
- Start
- 2021-08-07
- Primary completion
- 2022-02-18
- Completion
- 2022-02-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant SARS-CoV-2 Fusion Protein Vaccine | Vaccine | 10 ug | Intramuscular |