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. (part of Joincare Pharmaceutical Group Industry Co., Ltd.) · 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).
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 10,381 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Livzon Pharmaceutical Group Inc. is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
First submitted after Livzon Pharmaceutical Group Inc. became part of Joincare Pharmaceutical Group Industry Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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Studies of the drug tested here: V-01
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