NCT05928455

The Immunogenicity and Safety Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine LYB001

A Clinical Trial to Assess the Immunogenicity and Safety Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Adults 18-59 Years of Age Completed Two- or Three-dose Inactivated COVID-19 Vaccine

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Guangzhou Patronus Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess the immunogenicity and safety following a heterologous booster dose of recombinant SARS-CoV-2 vaccine (CHO cell) LYB001 in adults 18-59 years of age completed two- or three-dose inactivated COVID-19 vaccine. The main questions it aims to answer are: * whether LYB001 group is better on immunogenicity than the control group of inactivated vaccine? * whether LYB001 group has better performance on safety than the control group of inactivated vaccine, such as the lower adverse reaction rate?

Detailed description

Primary Objectives 1. To assess the immunogenicity profile following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine. 2. To assess the safety profile following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine. Secondary Objectives 1) To assess the immune durability following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine. Exploratory objectives 1\) To assess the cellular immune response following a heterologous booster dose of LYB001 as compared to a homologous booster dose of inactivated vaccine in adults 18-59 years of age completed two- or three-dose primary series of inactivated vaccine.

Conditions

• COVID-19
• Vaccine Reaction

Interventions

Type	Name	Description
BIOLOGICAL	LYB001	Experimental: The LYB001 vaccine was administered through intramuscular injection at doses of 30ug or 60ug in a 0.5mL volume.
BIOLOGICAL	CoronaVac	Active Comparator: The CoronaVac vaccine was administered through intramuscular injection in a 0.5mL volume.

Timeline

• Start date: 2022-05-14
• Primary completion: 2022-10-10
• Completion: 2023-06-30
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: China