COVID-19 PandemicPhase 2COVID-19NCT05238649
Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine
A Phase 2 study testing Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg, Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg and SARS-Cov-2 Vaccine Inactivated in people with COVID-19 Pandemic, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial summary
A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg, Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg and SARS-Cov-2 Vaccine Inactivated
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2021to 28 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants aged 18 years and older who have completed the second dose of 2-dose regimen of SARS-CoV-2 Inactivated Vaccine in the past 6 (±1) months;
- Voluntarily participate in the study and sign the informed consent form, who can provide valid ID and follow the study protocol requirement;
- In the past 14 days, no history of high or medium risk of the epidemic, overseas travel history or residence history; no history of contact with confirmed, asymptomatic or suspected COVID-19 cases; no history of contact with the persons from high- and medium-risk epidemic areas or contact patients with fever or respiratory symptoms; and those who are not in isolation period.
- Males of reproductive potential and females of childbearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 3 months after vaccination.
Who cannot join
- 1. Confirmed COVID-19 cases, or positive for SARS-CoV-2 test by RT-PCR. 2. History of previous SARS infection. 3. History of severe allergy to any vaccine or any ingredient of the vaccine including aluminum adjuvant, e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioedema, etc.
- 4. People who currently suffer from the following diseases:
- Symptoms related to acute respiratory infections (such as: sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste, chills, shortness of breath, etc.)
- Patients with thrombocytopenia, any coagulation dysfunction, or receive anticoagulant treatment, etc.
- Patients with congenital or acquired angioedema/neuroedema;
- A history of congenital or acquired immunodeficiency or autoimmune disease (except for mild psoriasis, controllable autoimmune thyroid disease, vitiligo, or stable celiac disease that does not require immunosuppressive or immunomodulatory therapy); no spleen , or history of spleen surgery, history of trauma, or treatment with immunomodulators within 6 months, such as: glucocorticoid with the dose causing immunosuppressive (dose reference: equivalent to prednisone 20mg/day, more than one week); or monoclonal antibody ; or thymosin; or interferon, etc.; but local medication (such as ointment, eye drops, inhalation or nasal spray) is allowed.
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- Patients with active tuberculosis, viral hepatitis, human immunodeficiency virus or syphilis infection.
- Patients with acute diseases, or acute attacks of chronic diseases, or uncontrolled severe chronic diseases: history of chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis), hypertension that cannot be controlled by drugs (systolic blood pressure ≥150mmHg) And/or diastolic blood pressure ≥100mmHg), history of severe cardiovascular disease (including heart failure, coronary artery disease, cardiomyopathy), history of chronic kidney disease, history of cancer (except for basal cell carcinoma), diabetes (unsatisfied blood sugar control or diabetes related serious complications).
- 5. Received inactivated vaccines or any subunit vaccines within 14 days before the vaccination and attenuated live vaccine within 28 days before the vaccination.
- 6. Injection of immunoglobulin and/or other blood products within 3 months before the administration of study vaccine; or with the plan to use such product within 6 month after immunization.
- 7. Pregnant (including positive urine pregnancy test for women of childbearing age) or breastfeeding women. Or women or their partners who have a pregnancy plan within 3 months after the trial vaccination.
- 8. Have participated in or are participating in other COVID-19 related clinical trials, or are participating in other drug clinical trials; 9. Those considered by the investigator as inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety 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
A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety 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
Read the detailed description
This is a Randomized, Double Blind, Positive Control exploratory clinical study. 150 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines 6 months (±1 month) ago were enrolled in this study to evaluate the safety and immunogenicity of V-01.
The participants will be enrolled to test group A (V-01 10 μg), test group B (V-01 25 μg) and test group C (inactivated vaccine) by the ratio of 1:1:1. The participants received 1 dose of V-01 or inactivated vaccine base on the group.
The random stratification factor is age (18-59 years old vs. ≥ 60 years old).
- Conditions
- COVID-19 Pandemic
- Being tested
- Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg, Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg, SARS-Cov-2 Vaccine Inactivated
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μgBiological
Also called V-01 10μg
The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μgBiological
Also called V-01 25μg
The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
SARS-Cov-2 Vaccine InactivatedBiological
Also called Inactivated vaccine
The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
| Study group | Role | What they receive |
|---|---|---|
| V-01 10 μg | Experimental | 10 μg(0.5ml)/vial, one dose administrated by intramuscular injection Receives: Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg |
| V-01 25 μg | Experimental | 25 μg(0.5ml)/vial, one dose administrated by intramuscular injection Receives: Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg |
| Inactivated vaccine | Active comparator | 0.5ml/vial, containing 100U inactivated COVID-19 virus antigen. One dose administrated by intramuscular injection Receives: Biological: SARS-Cov-2 Vaccine Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies
The Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies
Measured: 28 days after booster immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start10 Nov 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion28 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ligong Lu, Dr., Principal investigator, Zhuhai People's Hospital Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238649
- Sponsor's protocol ID
- ICV-V-01-Booster-A
- Acronym
- COVID-19
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety 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
- ClinicalTrials.gov ID
- NCT05238649
- Acronym / sponsor ID
- COVID-19 / ICV-V-01-Booster-A
- Conditions
- COVID-19 Pandemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 28 Jan 2023 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety 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
Detailed description
This is a Randomized, Double Blind, Positive Control exploratory clinical study. 150 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines 6 months (±1 month) ago were enrolled in this study to evaluate the safety and immunogenicity of V-01.
The participants will be enrolled to test group A (V-01 10 μg), test group B (V-01 25 μg) and test group C (inactivated vaccine) by the ratio of 1:1:1. The participants received 1 dose of V-01 or inactivated vaccine base on the group.
The random stratification factor is age (18-59 years old vs. ≥ 60 years old).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V-01 10 μg | Experimental | Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg10 μg(0.5ml)/vial, one dose administrated by intramuscular injection |
| V-01 25 μg | Experimental | Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg25 μg(0.5ml)/vial, one dose administrated by intramuscular injection |
| Inactivated vaccine | Active comparator | Biological: SARS-Cov-2 Vaccine Inactivated0.5ml/vial, containing 100U inactivated COVID-19 virus antigen. One dose administrated by intramuscular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy participants aged 18 years and older who have completed the second dose of 2-dose regimen of SARS-CoV-2 Inactivated Vaccine in the past 6 (±1) months;
- Voluntarily participate in the study and sign the informed consent form, who can provide valid ID and follow the study protocol requirement;
- In the past 14 days, no history of high or medium risk of the epidemic, overseas travel history or residence history; no history of contact with confirmed, asymptomatic or suspected COVID-19 cases; no history of contact with the persons from high- and medium-risk epidemic areas or contact patients with fever or respiratory symptoms; and those who are not in isolation period.
- Males of reproductive potential and females of childbearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 3 months after vaccination.
Key exclusion criteria (12 listed)
- 1. Confirmed COVID-19 cases, or positive for SARS-CoV-2 test by RT-PCR. 2. History of previous SARS infection. 3. History of severe allergy to any vaccine or any ingredient of the vaccine including aluminum adjuvant, e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioedema, etc.
- Symptoms related to acute respiratory infections (such as: sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste, chills, shortness of breath, etc.)
- Patients with thrombocytopenia, any coagulation dysfunction, or receive anticoagulant treatment, etc.
- Patients with congenital or acquired angioedema/neuroedema;
- A history of congenital or acquired immunodeficiency or autoimmune disease (except for mild psoriasis, controllable autoimmune thyroid disease, vitiligo, or stable celiac disease that does not require immunosuppressive or immunomodulatory therapy); no spleen , or history of spleen surgery, history of trauma, or treatment with immunomodulators within 6 months, such as: glucocorticoid with the dose causing immunosuppressive (dose reference: equivalent to prednisone 20mg/day, more than one week); or monoclonal antibody ; or thymosin; or interferon, etc.; but local medication (such as ointment, eye drops, inhalation or nasal spray) is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μgAlso: V-01 10μgThe product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection. | Biological | V-01 10 μg |
| Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μgAlso: V-01 25μgThe product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection. | Biological | V-01 25 μg |
| SARS-Cov-2 Vaccine InactivatedAlso: Inactivated vaccineThe product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection. | Biological | Inactivated vaccine |
Primary outcome
Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies
Time frame: 28 days after booster immunization
The Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ligong Lu, Dr. principal investigator
Zhuhai People's Hospital Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg, Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg and SARS-Cov-2 Vaccine Inactivated in people with COVID-19 Pandemic, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies (time frame: 28 days after booster immunization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.