NCT06167915

Safety and Immunogenicity of Recombinant COVID-19 Trivalent Protein Vaccine （CHO Cell）LYB002V14 in Booster Vaccination

A Randomized, Blinded, Placebo-Controlled, Dose Escalation Phase 1 Trial of Recombinant COVID-19 Trivalent (XBB.1+BQ.1.1+Prototype) Protein Vaccine （CHO Cell）（LYB002V14） in Booster Vaccination in Participants Aged 18 Years Old and Above

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Guangzhou Patronus Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, blinded, and dose escalation phase I trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of Recombinant COVID-19 Trivalent (XBB.1+BQ.1.1+Prototype) Protein Vaccine （CHO Cell）（LYB002V14）.

Detailed description

The study is a randomized, blinded and dose escalation Phase I clinical trial. It will evaluate the safety and immunogenicity of 2 dose levels of recombinant COVID-19 trivalent (XBB.1+BQ.1.1+Prototype) protein vaccine （CHO Cell）（LYB002V14）in booster vaccination. Approximately 120 participants aged 18 years and older will be enrolled in this study. The subjects in each dose group will randomly receive an intramuscular （IM） injection of experimental vaccine or placebo on Days 0 in the deltoid muscle at 2:1 and will be followed through 12 months post vaccination.

Conditions

• SARS-CoV-2
• COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	30μg dose of LYB002V14	30μg dose of LYB002V14 vaccine IM, on day 0
BIOLOGICAL	60μg dose of LYB002V14	60μg dose of LYB002V14 vaccine IM, on day 0
BIOLOGICAL	placebo	placebo IM, on day 0

Timeline

• Start date: 2023-12-26
• Primary completion: 2024-12-26
• Completion: 2024-12-31
• First posted: 2023-12-13
• Last updated: 2023-12-26

Locations

1 site across 1 country: China