A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Older

Guangzhou Patronus Biotech Co., Ltd.2 sites in 1 country3,000 target enrollmentDecember 29, 2022

ConditionsCOVID-19

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: COVID-19
Sponsor: Guangzhou Patronus Biotech Co., Ltd.
Enrollment: 3000
Locations: 2
Primary Endpoint: First occurrence of confirmed symptomatic COVID-19 incidence rate per person-years of follow-up
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an international multicenter clinical trial, which is planned to be conducted in several research centers in China and Pakistan. A randomized, double-blind, placebo-controlled design will be conducted to evaluate the efficacy, safety of LYB001 against COVID-19 as a booster dose in China.

Detailed Description

3000 subjects aged 18 years and older who have completed two or three doses of SARS-CoV-2 inactivated vaccine 6-18 months will be enrolled in China. Participants are randomly assigned to LYB001 or placebo group at a ratio of 1:1 and receive one dose at day 0.

Registry

clinicaltrials.gov

Start Date

December 29, 2022

End Date

July 12, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangzhou Patronus Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects aged 18 years and older, including both males and females;
•Subjects who agree to participate in this clinical trial voluntarily and sign the informed consent form, are capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
•Subjects who have been vaccinated with two-dose or three-dose inactivated COVID-19 vaccine for 6-18 months (including boundary values).
•For female participants of childbearing potential, effective contraception measures should be used within 2 weeks prior to participation in this study and the results of pregnancy test is required to be negative. Participants should voluntarily agree to use effective contraceptive measures from the time of signing the informed consent form to the end of the study (effective contraceptive measures including oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).

Exclusion Criteria

•Receipt of any COVID-19 vaccines other than inactivated COVID-19 vaccine;
•Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (for subjects with poorly controlled blood pressure);
•Axillary body temperature ≥ 37.3°C prior to enrolment;
•Known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;
•History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
•History of COVID-19, or positive results for SARS-CoV-2 nucleic acid or antigen tests at screening;
•Receipt of any live attenuated vaccine within 28 days prior to vaccination, and other vaccines such as subunit and inactivated vaccine within 14 days prior to vaccination;
•Receipt of blood or blood-related products, including immunoglobulins, monoclonal antibodies, within 3 months prior to vaccination; or any planned use during the study period.
•Subjects with the following diseases:
•Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment；

Outcomes

Primary Outcomes

First occurrence of confirmed symptomatic COVID-19 incidence rate per person-years of follow-up

Time Frame: From 14 days after the booster dose

First occurrence of confirmed symptomatic COVID-19 incidence rate from 14 days after the booster dose per person-years of follow-up;

Secondary Outcomes

The occurrence of adverse events(The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination)
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs)(Day 0 to 12 months after vaccination)
First occurrence of confirmed severe, critical, and fatal COVID-19 incidence per person-years of follow-up(From 14 days after the booster)