NCT05663086

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

A Randomized, Blinded, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Population Aged 18 Years and Above（Negative for Antibody Against COVID-19）

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Guangzhou Patronus Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, blinded, positive-controlled study to evaluate the immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above（negative antibody against COVID-19）. 720 subjects will be recruited in this study, including 360 in 1 dose of 30 or 60 μg group and 360 in 2 doses of 30 or 60 μg group. The age group consists of 18-59 years old and 60 years old and above.

Detailed description

Subjects will receive 1 dose or 2 doses of LYB001, according to the immunization schedule of 0 day or 0, 28 days. The adverse events within 28 days after each vaccination will be observed. In addition, blood samples will be collected on day 0 before vaccination,and on day 7, 14, 28 and month 3, 6, 12 after full vaccination. Serum antibody levels, cellular immune responses will be analyzed to evaluate the immunogenicity and immune persistence of the vaccine.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	One dose group	The vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
BIOLOGICAL	Two doses group	The vaccines are to be administrated at day 0 and 28. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
BIOLOGICAL	Aged 18-59 years	The vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
BIOLOGICAL	Aged 60 years old and above	The vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

Timeline

• Start date: 2023-01-07
• Primary completion: 2023-06-27
• Completion: 2023-06-27
• First posted: 2022-12-23
• Last updated: 2023-09-26

Locations

1 site across 1 country: China