NCT05664932

Immunogenicity and Safety of COVID-19 Vaccine as a Booster Vaccination in Population Aged 18 Years and Above

Evaluate the Immunogenicity and Safety of a Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Above Who Have Completed Two-dose or Three-dose Inactivated COVID-19 Vaccine

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Guangzhou Patronus Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A total of 1200 people aged 18 years and older who have completed two or three-dose inactivated COVID-19 vaccine for 6-18 months will be recruited in this study. Subjects will be received 1 dose at day 0 as a booster vaccination.Immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 will be evaluated.

Detailed description

The study is a randomized, double-blind, positive control design and 1200 subjects are randomly assigned to LYB001 and positive control groups in a 1:1 ratio to evaluate the safety and immunogenicity as a booster vaccination.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001	Intramuscular injection of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.
BIOLOGICAL	ZF2001	Intramuscular injection of ZF2001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.

Timeline

• Start date: 2022-12-28
• Primary completion: 2023-01-18
• Completion: 2023-12-31
• First posted: 2022-12-27
• Last updated: 2023-09-26

Locations

1 site across 1 country: China