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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
10,381
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
The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Sunway Medical Centre Velocity (SMCV) Cheras
Kuala Lumpur, Malaysia
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.
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Hospital Pakar Sultanah Fatimah
Muar town, Malaysia
Sunway Medical Centre (SunMed)
Petaling Jaya, Malaysia
Hospital Pulau Pinang
Pulau Pinang, Malaysia
Klinik Kesihatan Seremban 2
Seremban, Malaysia
Seri Manjung Hospital
Seri Manjung, Malaysia
Hospital Sibu
Sibu, Malaysia
Hospital Sultan Abdul Halim
Sungai Petani, Malaysia
Hospital Taiping
Taiping, Malaysia
...and 8 more locations
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