A Phase 3 interventional study of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) and Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in COVID-19 Pandemic, sponsored by Livzon Pharmaceutical Group Inc.. Completed at 18 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Livzon Pharmaceutical Group Inc. · Phase 3, Interventional, and Prevention
A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older after the Vaccination of 2 Doses of Inactivated Vaccines
This is a global, multicenter, randomized, double-blind, placebo-controlled phase III clinical study. Approximately 10,722 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines (BBIBP-CorV or CoronaVac) will be enrolled in this study to evaluate the efficacy, safety and immunogenicity of V-01.
The eligible participants will be randomly assigned to receive dose of either 10 μg V-01 or a placebo in a 1:1 randomization ratio. Assignment will be stratified by age (18-59 years vs. ≥ 60 years), gender (male vs. female), whether or not being enrolled into immunogenicity subgroup (yes vs no), and the types of inactivated vaccines (BBIBP-CorV vs. CoronaVac).
Participants are eligible to be included in the study only if all of the following criteria apply:
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause).
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
1 dose on Day 0, which should be 3-6 months after the second dose of 2-dose regimen of inactive vaccine (BBIBP-CorV or CoronaVac).
Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)
1 dose on Day 0, which should be 3-6 months after the second dose of 2-dose regimen of inactive vaccine (BBIBP-CorV or CoronaVac).
Biological: Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)
Appearance: Creamy white suspension Dosage form: Suspension for injection Strength: 10 μg (0.5 mL) /vial Vaccination route: Intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg (0.5 mL) Immunization schedule: 1 dose on Day 0, which should be 3-6 months after the second dose of 2-dose regimen of inactive vaccine (BBIBP-CorV or CoronaVac). Storage condition: Store at 2-8 °C protected from light Expiry date: 24 months temporarily
Also known as: V-01
The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.
Also known as: Placbo
the relative efficacy of recombinant SARS-CoV-2 fusion protein vaccine (V-01) as a booster to prevent symptomatic and RT-PCR positive COVID-19 (mild or above severity)
To evaluate the relative efficacy of recombinant SARS-CoV-2 fusion protein vaccine (V-01) as a booster to prevent symptomatic and reverse transcription polymerase chain reaction (RT-PCR) positive COVID-19 (mild or above severity) compared with the placebo control group.
Time frame: From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization
The incidence of adverse events (AEs)
To evaluate the incidence of adverse events (AEs) within 28 days after the booster vaccination.
Time frame: Within 28 days after the booster vaccination
The relative vaccine efficacy of V-01 as a booster to prevent severe or above COVID-19
To evaluate the relative vaccine efficacy of V-01 as a booster to prevent severe or above COVID-19 compared with the placebo control group.
Time frame: From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization
The relative vaccine efficacy of V-01 as a booster to prevent symptomatic and RT-PCR positive COVID-19 (mild or above severity)
To evaluate the relative vaccine efficacy of V-01 as a booster to prevent symptomatic and RT-PCR positive COVID-19 (mild or above severity) in different age subgroups compared with the placebo control group.
Time frame: From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization
The relative vaccine efficacy of V-01 as a booster to prevent suspected but not confirmed COVID-19
To evaluate the relative vaccine efficacy of V-01 as a booster to prevent suspected but not confirmed COVID-19 compared with the placebo control group.
Time frame: From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization
The relative vaccine efficacy of V-01 as a booster to prevent death caused by COVID-19
To evaluate the relative vaccine efficacy of V-01 as a booster to prevent death caused by COVID-19 compared with the placebo control group.
Time frame: From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization
The relative vaccine efficacy of V-01 as a booster to prevent hospitalization caused by COVID-19
To evaluate the relative vaccine efficacy of V-01 as a booster to prevent hospitalization caused by COVID-19 compared with the placebo control group.
Time frame: From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization
The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
To evaluate the incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after the booster vaccination.
Time frame: Within 12 months after the booster vaccination
The seroconversion rate of serum SARS-CoV-2 RBD protein-binding antibody, GMT and GMI (Immunology Subgroup Only)
To evaluate the immunogenicity of V-01.
Time frame: At day 14, day 28, month 3, month 6, and month 12 after immunization
The genotype of SARS-CoV-2 in symptomatic and RT-PCR positive COVID-19 cases.
To explore the genotype of SARS-CoV-2 in symptomatic and RT-PCR positive COVID-19 cases.
Time frame: From the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after immunization
Immunogenicity of V-01 against new SARS-CoV-2 variants
To explore the immunogenicity of V-01 against new SARS-CoV-2 variants.
Time frame: From the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after immunization
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Livzon Pharmaceutical Group Inc.