A Phase 1 interventional study of Recombinant SARS-CoV-2 Fusion Protein Vaccine in COVID19, sponsored by Livzon Pharmaceutical Group Inc.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Livzon Pharmaceutical Group Inc. (part of Joincare Pharmaceutical Group Industry Co., Ltd.) · Phase 1, Interventional, and Prevention
This study is a continuation study of the original V-01-I phase trial, using a single-center, single-arm, open design to evaluate the immunogenicity and safety of the third dose booster immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in healthy participants immunized with two doses schedule of V-01.
The primary objective is to evaluate the Immunogenicity of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.
The secondary objective is to evaluate the safety of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.
The plan is to booster immunize the participants previously in 10μg test group in V-01 clinical trial phase I, 48 participants are planned to be enrolled. The actual case number will be calculated by the participants who signed the ICF and got actual inoculation with the third dose.
Vaccination and follow-up:
Three to six months after the two doses of V-01 (10 μg) were vaccinated, the participants received a booster dose of investigational vaccine (V-01, 10 μg) at the deltoid muscle of the upper arm.
Perform safety and immunogenicity related inspections in accordance with the schedule in the plan.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 43 is below 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.
Exclusion Criteria:
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
One dose administrated by intramuscular injection
Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine
The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
Also known as: V-01
Immunogenicity Endpoints
1. The seroconvension, GMT, and GMI of SARS-CoV-2 neutralizing antibodies (live virus, pseudovirus neutralizing test method) 2. The seroconvension, GMT, and GMI of SARS-CoV-2 RBD antibodies (Enzyme-linked Immuno Sorbent Assay，ELISA)
Time frame: 14 days after booster immunization
Safety Endpoints
1. The occurrence of AEs at each time point (at least 30 minutes, 0-7 days, and within 30 days after booster vaccination); 2. The incidence of serious adverse events (SAE) (within 6 months after booster vaccination).
Time frame: Day 0-7 after booster immunization, 6 months after booster 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
Livzon Pharmaceutical Group Inc. →