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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001; Biological: ZF2001

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.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhonghua Yang; Phone Number: +86 15920092658; Email: yangzhonghua@luye.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Provincial Center for Disease Control and Prevention
      • Contact: Xianfeng Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 .
• 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 prophylactic medication other than inactivated COVID-19 vaccine (e.g., receipt history of any approved or under developing COVID-19 vaccines, or other COVID-19 prophylactic medication, etc.), or previous vaccination history other than two- or three-dose inactivated COVID-19 vaccination;
• Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg or 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 close contact with a confirmed/suspected COVID-19 patient or positive results for SARS-CoV-2 nucleic acid ;
• 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:

  1. Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment；
  2. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.；
  3. Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids；
  4. Currently suffering from or diagnosed with infectious diseases, such as hepatitis B, hepatitis C, syphilis, AIDS etc.；
  5. History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders；
  6. Asplenia, or functional asplenia；
  7. Presence of severe, uncontrollable or hospitalized cardiovascular diseases, endocrine diseases, blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors;
  8. Contraindications to IM injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage.
• Drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures;
• Pregnant or lactating females;
• Having participated or participating in COVID-19 related clinical trials, and those participating or planning to participate in other clinical trials during the study period;
• Presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LYB001 Booster Group; Subjects 18 years of age or older who has completed two or three-dose inactivated COVID-19 will receive 30μg LYB001 at day 0 as a booster vaccination.	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.
Active Comparator: ZF2001 Booster Group; Subjects 18 years of age or older who has completed two or three-dose inactivated COVID-19 will receive ZF2001 at day 0 as a booster vaccination.	Biological: ZF2001; Intramuscular injection of ZF2001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric neutralizing titers (GMT) of neutralizing antibody against variants of concern(VOCs)	Geometric neutralizing titers (GMT) of neutralizing antibody against variants of concern(VOCs) at day 14 after booster vaccination in cohort 1.	Day 14 after booster vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)	Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14, day 28, month 6 after booster vaccination in cohort 1.	Day 14 ,day 28 ,month 6 after vaccination
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).	Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14, day 28, month 6 after booster vaccination in cohort 1.	Day 14 ,day 28 ,month 6 after vaccination
Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain	Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain at day 14, day 28, month 6 after booster vaccination in cohort 1.	Day 14 ,day 28 ,month 6 after vaccination
GMT of binding antibody against SARS-CoV-2 S protein	GMT of binding antibody against SARS-CoV-2 S protein at day 14, day 28, month 6 after booster vaccination in cohort 1.	Day 14 ,day 28 ,month 6 after vaccination
Geometric mean fold rise(GMFR) of binding antibody against SARS-CoV-2 S protein	Geometric mean fold rise(GMFR) of binding antibody against SARS-CoV-2 S protein at day 14, day 28, month 6 after booster vaccination in cohort 1.	Day 14 ,day 28 ,month 6 after vaccination
Seroconversion rate of binding antibody against SARS-CoV-2 S protein	Seroconversion rate of binding antibody against SARS-CoV-2 S protein at day 14, day 28, month 6 after booster vaccination in cohort 1.	Day 14 ,day 28 ,month 6 after vaccination
The occurrence of adverse events	The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccinatio	30 mins,7 days and 28 days after vaccination
The occurrence rate of serious adverse events (SAEs) and adverse events of special interest (AESIs)	The occurrence rate of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after vaccination（28 days after vaccination for positive control group）	Day 0 to 12 months after vaccination

Collaborators and Investigators

• Sponsor: Guangzhou Patronus Biotech Co., Ltd.
• Collaborators: Yantai Patronus Biotech Co., Ltd.
• Investigators: Principal Investigator: Xianfeng Zhang, Hubei Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Actual): January 18, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: LYB001/CT-CHN-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No