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Clinical Trial Summary

A Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines


Clinical Trial Description

This is a single arm, open-label clinical study. 45 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines will be enrolled in this study to evaluate the safety and immunogenicity of V-01. The participants will be collected blood before immunization, on day 7, day 14, day 28 and 6 month to evaluate humoral immunity. All adverse events (AEs) within 30 minutes and 0-7 days after booster immunization, and unsolicited AEs from 8 to 28 days after booster immunization, as well as SAEs and AESIs from the first vaccination to 12 months after booster immunization will be collected from all participants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05125874
Study type Interventional
Source Livzon Pharmaceutical Group Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date September 30, 2021
Completion date September 30, 2023

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