COVID-19 Clinical Trial
Official title:
Safety and Immunogenicity of Sequential Immunization of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine Against COVID-19 in Chinese Healthy Population: Randomized, Observer-blind, Placebo-controlled Study
This is a randomized, observer-blind, placebo-controlled study, for evaluation of safety and immunogenicity of sequential immunization of recombinant COVID-19 vaccine (adenovirus type-5 vector) and RBD-based protein subunit vaccine (ZF2001) against COVID-19 in Chinese healthy population. 120 healthy subjects aged over 18 years of age who have been vaccinated with recombinant adenovirus type-5 vectored vaccine will be recruited in this study. Of them, 60 subjects will be enrolled in the "0-28 days" regimen and other 60 will be enrolled in "0-56 days" regimen. Subjects in each regimen will be randomly vaccinated with the boost dose of subunit vaccine(ZF2001) against COVID-19 or a commercial influenza vaccine in a ratio of 2:1. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on the day 0 before and after the boost vaccination on day 14, 28 and 6 months after second vaccination to test serum antibody levels and to profile the immune cells' subgroups and germlines. Each subject will remain in this study for approximately 6 months.
n/a
| NCT number | NCT04833101 |
| Study type | Interventional |
| Source | Jiangsu Province Centers for Disease Control and Prevention |
| Contact | Jing-Xin Li, PhD |
| Phone | #86-25-83759913 |
| [email protected] | |
| Status | Recruiting |
| Phase | Phase 4 |
| Start date | April 7, 2021 |
| Completion date | December 15, 2021 |
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