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Safety and Immunogenicity of COVID-19 Vaccine in Population Aged 18 Years and Above

COVID-19 Clinical Trial

Official title:
A Randomized, Blinded, Positive-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Population Aged 18 Years and Above

Clinical Trial Summary

This is a randomized, blinded, positive-controlled study to evaluate the safety and immnunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above. 100 subjects will be recruited in this study, including 50 aged 18-59 years old and 50 aged 60 years old and above.

Clinical Trial Description

All subjects will be received 3 doses of LYB001, according to the immunization schedule of 0, 28, 56 days. The adverse events within 28 days after vaccination will be observed. In addition, blood samples will be collected on day 0 before vaccination,day 14 after dose 2, and on day 14, 28 and month 3, 6, 9, 12 after full vaccination. Serum antibody levels, cellular immune responses will be analyzed to evaluate the immunogenicity and immune persistence of the vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05552573
Study type Interventional
Source Guangzhou Patronus Biotech Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1
Start date July 19, 2022
Completion date December 1, 2023
View Details
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