Efficacy and Safety of LYB001 as Booster Vaccination in Adults 18 Years of Age or Older

Sponsor
Guangzhou Patronus Biotech Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05683600
Collaborator
Yantai Patronus Biotech Co., Ltd. (Industry)
3,000
2
2
12.4
1500
121.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001
  • Biological: Placebo
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Dec 29, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Jan 10, 2024

Arms and Interventions

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: 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

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

Outcome Measures

Primary Outcome Measures

  1. First occurrence of confirmed symptomatic COVID-19 incidence rate per person-years of follow-up [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 Outcome Measures

  1. The occurrence of adverse events [The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination]

    The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination

  2. The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) [Day 0 to 12 months after vaccination]

    The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after vaccination

  3. First occurrence of confirmed severe, critical, and fatal COVID-19 incidence per person-years of follow-up [From 14 days after the booster]

    First occurrence of confirmed severe, critical, and fatal COVID-19 incidence from 14 days after the booster dose per person-years of follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bishan District People's Hospital,Chongqing Chongqing Chongqing China 402760
2 Shandong Provincial Center for Disease Control and Prevention Jinan Shandong China 250014

Sponsors and Collaborators

  • Guangzhou Patronus Biotech Co., Ltd.
  • Yantai Patronus Biotech Co., Ltd.

Investigators

  • Principal Investigator: Chengyong Tang, Chongqing Bishan District People's Hospital
  • Principal Investigator: Li Zhang, Shandong Provincial Center for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guangzhou Patronus Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05683600
Other Study ID Numbers:
  • LYB001/CT-CHN-302
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 13, 2023