COVID-19 Pandemic
Conditions
Keywords
V-01
Brief summary
A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older
Detailed description
This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III clinical study. Approximately 22,500 participants aged 18 years and older will be enrolled in this study to evaluate the efficacy, safety and immunogenicity of recombinant SARS-CoV-2 fusion protein vaccine (code: V-01, hereinafter referred to as V-01). The eligible participants will be randomized in a 2:1 ratio into investigational vaccine group (V-01) and placebo group, with random stratification factors including 1) age (18-59 years vs ≥60 years); 2) gender (male vs female); and 3) whether or not being enrolled into immunogenicity subgroup (yes vs no). The participants will receive investigational vaccine V-01 or placebo on two doses schedule (one dose each on day 0 and 21, with +7 days' time window for the second dose).
Interventions
Appearance: creamy white suspension Dosage form: Suspension for injection Strength: 10 μg (0.5mL) /vial Vaccination route: intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg Immunization schedule: two doses, one each on Day 0 and 21 (+7 days), respectively. Storage condition: store at 2\ 8°C protected from light Expiry date: 24 months after production date
The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.
Sponsors
Livzon Pharmaceutical Group Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The participants can be enrolled only all of the following criteria are met: 1. Voluntarily participate in this study and sign the informed consent form; 2. Adults aged 18 years and older, male or female; 3. According to the assessment of the investigator, the participant has a stable medical condition (which is defined as no significant changes in therapy or hospitalization caused by disease aggravation within 3 months before enrollment) and is able to and willing to follow the requirements of the protocol. 4. Males of reproductive potential and females of child-bearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 12 months after full-course immunization; females of child-bearing potential have a negative pregnancy test at screening and at the day of vaccination.
Exclusion criteria
Participants meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) | More than 14 days (≥15 days) after full course immunization | To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above severity) starting from at least 14 days (≥15 days) after full-course immunization (completing all vaccinations); |
| The incidence of adverse events (AEs) of V-01 | From the first vaccination to 28 days after full-course immunization | To evaluate the incidence of adverse events (AEs) of recombinant SARS-CoV-2 fusion protein vaccine (V-01) from the first vaccination to 28 days after full-course immunization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The morbidity of suspected but not confirmed COVID-19 (negative or not detected) | More than 14 days (≥15 days) after full-course immunization; | To evaluate the morbidity of suspected but not confirmed COVID-19 (negative or not detected) |
| The mortality caused by COVID-19 | More than 14 days (≥15 days) after full-course immunization; | To evaluate the mortality caused by COVID-19 |
| The hospitalization rate caused by COVID-19 | More than 14 days (≥15 days) after full-course immunization; | To evaluate the hospitalization rate caused by COVID-19 |
| The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) | From the first dose of recombinant SARS-CoV-2 fusion protein vaccine (V-01) to 12 months after full-course immunization | To evaluate the incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) occurred from the first dose of recombinant SARS-CoV-2 fusion protein vaccine (V-01) to 12 months after full-course immunization |
| The seroconversion rate of serum SARS-CoV-2 RBD protein-binding antibody, geometric mean titer (GMT) and geometric mean increase (GMI) | At day 28, month 3, month 6, and month 12 after full-course immunization | 1. To evaluate the seroconversion rate of serum SARS-CoV-2 RBD protein-binding antibody, geometric mean titer (GMT) and geometric mean increase (GMI) at day 28, month 3, month 6, and month 12 after full-course immunization (enzyme-linked immunosorbent assay \[ELISA\]); 2. To evaluate the seroconversion rate of serum anti-SARS-CoV-2 neutralizing antibody, GMT and GMI at day 28, month 3, month 6, and month 12 after full-course immunization (live virus neutralization assay); |
| The efficacy of V-01 for the prevention of COVID-19 of severe or above in severity | More than 14 days (≥15 days) after full-course immunization; | To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of COVID-19 of severe or above severity starting from at least 14 days (≥15 days) after full-course immunization; |
| The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) | More than 14 days (≥15 days) after full-course immunization; | To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) starting from more than 14 days after the first vaccination; |
| The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) in different age groups | More than 14 days (≥15 days) after full-course immunization; | To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) starting from more than 14 days after full-course immunization in different age groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| The immunogenicity of V-01 against new SARS-CoV-2 variants | From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization | To explore the immunogenicity of V-01 against new SARS-CoV-2 variants |
| The severity of COVID-19, so as to evaluate the vaccine-mediated antibody-dependent enhancement (ADE) | From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization | To evaluate the severity of COVID-19 of participants in the vaccine group versus the control group, so as to evaluate the vaccine-mediated antibody-dependent enhancement (ADE) |
| SARS-CoV-2 nucleic acid sequence in symptomatic and RT-PCR-positive COVID-19 cases | From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization | Genotypic analyses of SARS-CoV-2 nucleic acid sequence in symptomatic and RT-PCR-positive COVID-19 cases. |
| The correlation of immunogenicity and efficacy through evaluating the titer level of RBD protein-binding antibody in confirmed COVID-19 cases | From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization | To explore the correlation of immunogenicity and efficacy through evaluating the titer level of RBD protein-binding antibody in confirmed COVID-19 cases. |
Countries
Indonesia, Philippines, Russia
Outcome results
None listed