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

NCT05683600 | Terminated Phase 3 DMC

• 1 other identifier: LYB001/CT-CHN-302
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

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

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

  From 14 days after the booster dose

Secondary Outcomes (3)

• 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

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

Placebo Booster Group

ACTIVE COMPARATOR

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

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

Placebo BIOLOGICAL

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

Placebo 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 (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.).

You may not qualify if:

• 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；
• 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；

Sponsors & Collaborators

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

Study Sites (2)

Bishan District People's Hospital,Chongqing

Chongqing, Chongqing Municipality, 402760, China

Location

Shandong Provincial Center for Disease Control and Prevention

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

COVID-19

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

• Chengyong Tang

  Chongqing Bishan District People's Hospital

  PRINCIPAL INVESTIGATOR

• Li Zhang

  Shandong 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 25, 2022
• First Posted: January 13, 2023
• Study Start: December 29, 2022
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: September 28, 2023

Record last verified: 2022-12

Locations

CN (2)