Efficacy and Safety of COVID-19 Vaccine as Booster Vaccination in Adults 18 Years of Age or Older

NCT ID: NCT05683600

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-29
• Study Completion Date: 2023-07-12

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Placebo Booster Group

Subjects 18 years of age or older who has completed two or three-dose inactivated COVID-19 will receive placebo at day 0 as a booster vaccination

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yantai Patronus Biotech Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Guangzhou Patronus Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chengyong Tang

Role: PRINCIPAL_INVESTIGATOR

Chongqing Bishan District People's Hospital

Li Zhang

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Center for Disease Control and Prevention

Locations

Bishan District People's Hospital,Chongqing

Chongqing, Chongqing Municipality, China

Shandong Provincial Center for Disease Control and Prevention

Jinan, Shandong, China

Countries

China

Other Identifiers

LYB001/CT-CHN-302

Identifier Type: -

Identifier Source: org_study_id