Immunogenicity and Safety of COVID-19 Vaccine as a Booster Vaccination in Population Aged 18 Years and Above

NCT05664932 | Unknown Phase 3

• 1 other identifier: LYB001/CT-CHN-301
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)

  Day 14 ,day 28 ,month 6 after vaccination

• Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).

  Day 14 ,day 28 ,month 6 after vaccination

• Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain

  Day 14 ,day 28 ,month 6 after vaccination

• GMT of binding antibody against SARS-CoV-2 S protein

  Day 14 ,day 28 ,month 6 after vaccination

• Geometric mean fold rise(GMFR) of binding antibody against SARS-CoV-2 S protein

  Day 14 ,day 28 ,month 6 after vaccination

Study Arms (2)

LYB001 Booster Group

EXPERIMENTAL

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

ZF2001 Booster Group

ACTIVE COMPARATOR

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

Interventions

Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 BIOLOGICAL

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.

LYB001 Booster Group

ZF2001 BIOLOGICAL

Intramuscular injection of ZF2001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.

ZF2001 Booster Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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:
• Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment；
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.；
• 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；
• Currently suffering from or diagnosed with infectious diseases, such as hepatitis B, hepatitis C, syphilis, AIDS etc.；
• History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders；
• Asplenia, or functional asplenia；
• 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;

Sponsors & Collaborators

• Guangzhou Patronus Biotech Co., Ltd.: lead
• Yantai Patronus Biotech Co., Ltd.: collaborator

Study Sites (1)

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

Location

Related Publications (1)

• Yang BF, Jin J, He XR, Yang ZH, Qian X, Tong YQ, Ke CX, Li ZH, Li ZX, Zhong LF, Gan ZH, Zhang XF, Zeng Y. Immunogenicity and safety of SARS-CoV-2 recombinant protein vaccine (CHO cell) LYB001 as a heterologous booster following two- or three-dose inactivated COVID-19 vaccine in adults aged >/=18 years: interim results of a randomized, active-controlled, double-blinded, phase 3 trial. Expert Rev Vaccines. 2025 Dec;24(1):81-90. doi: 10.1080/14760584.2024.2446288. Epub 2025 Jan 5.

  PMID: 39720838 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ZF2001 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xianfeng Zhang

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: December 27, 2022
• Study Start: December 28, 2022
• Primary Completion: January 18, 2023
• Study Completion: December 31, 2023
• Last Updated: September 26, 2023

Record last verified: 2022-12

Locations

CN (1)