COVID19Phase 1NCT05050474
Booster Immunization Study of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)
A Phase 1 study testing Recombinant SARS-CoV-2 Fusion Protein Vaccine in people with COVID19, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19
- What is being tested?
- Recombinant SARS-CoV-2 Fusion Protein Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2021to 18 Feb 2022
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the study and sign the informed consent form
- The participants who were enrolled in the 10 μg test group in the previous study titled "A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Participants", and went through the full course immunization without meeting the exclusive criteria.
- No history of contact with confirmed, asymptomatic or suspected COVID-19 cases.
- 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 6 months after vaccination; females of childbearing age refer to premenopausal women and women within 2 years after menopause.
Who cannot join
- Innoculated with COVID-19 vaccines other than V-01;
- History of high fever (axillary temperature ≥ 39℃) and last for more than 3 days, or serious allergic reactions during the last immunization with V-01;
- History of obvious allergic reactions or allergic reactions that needed to be medical intervention during the last immunization with V-01;
- After two doses of V-01 inoculation, a newly diagnosed severe chronic disease or the original chronic disease is poorly controlled by drugs (applicable to ≥60 years old): history of chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis) , Hypertension which can not be controlled by drugs (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg), history of severe cardiovascular disease (including heart failure, coronary artery disease, cardiomyopathy), history of chronic kidney disease, history of cancer, diabetes (blood sugar) Unsatisfactory control or serious complications related to diabetes);
- Any confirmed or suspected immunosuppressive or immunodeficiency disorder, including HIV infection and asplenia; recurrent severe infections and administration of immunosuppressive drugs during the past 6 months, excluding topical steroids or short-term oral steroids (<14 days);
- Having received immunoglobulin and/or any blood products 3 months prior to the investigational vaccine dose;
- Other scenarios that may be medically, psychologically or socially contradicted with the trial protocol at the investigator's discretion or preclude informed consents of the participants.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Center for Disease Control and Prevention
Guangzhou, Guangdong, 511430
About this study
Official title: A Clinical Study 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
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.
Read the detailed description
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.
- Conditions
- COVID19
- Being tested
- Recombinant SARS-CoV-2 Fusion Protein Vaccine
- 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 VaccineBiological
Also called V-01
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 COVID-19 Vaccine | Experimental | One dose administrated by intramuscular injection Receives: Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity Endpoints
- The seroconvension, GMT, and GMI of SARS-CoV-2 neutralizing antibodies (live virus, pseudovirus neutralizing test method)
- The seroconvension, GMT, and GMI of SARS-CoV-2 RBD antibodies (Enzyme-linked Immuno Sorbent Assay，ELISA)
Measured: 14 days after booster immunization
Secondary outcomes (1)
Safety Endpoints
- The occurrence of AEs at each time point (at least 30 minutes, 0-7 days, and within 30 days after booster vaccination);
- The incidence of serious adverse events (SAE) (within 6 months after booster vaccination).
Measured: Day 0-7 after booster immunization, 6 months 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 posted20 Sep 2021
- Study start7 Aug 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangdong Center for Disease Prevention and Control, Simoon Record Pharma Information Consulting Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhang Jikai, Principal investigator, Guangdong Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050474
- Sponsor's protocol ID
- V-01-I-Booster
- Status last verified
- Apr 2023
- First submitted
- 13 Sep 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study 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
- ClinicalTrials.gov ID
- NCT05050474
- Acronym / sponsor ID
- V-01-I-Booster
- Conditions
- COVID19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Collaborators
- Guangdong Center for Disease Prevention and Control, Simoon Record Pharma Information Consulting Co., Ltd.
- Study start
- 7 Aug 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 20 Sep 2021 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V-01 COVID-19 Vaccine | Experimental | Biological: Recombinant SARS-CoV-2 Fusion Protein VaccineOne dose administrated by intramuscular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily participate in the study and sign the informed consent form
- The participants who were enrolled in the 10 μg test group in the previous study titled "A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Participants", and went through the full course immunization without meeting the exclusive criteria.
- No history of contact with confirmed, asymptomatic or suspected COVID-19 cases.
- 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 6 months after vaccination; females of childbearing age refer to premenopausal women and women within 2 years after menopause.
Key exclusion criteria (7 listed)
- Innoculated with COVID-19 vaccines other than V-01;
- History of high fever (axillary temperature ≥ 39℃) and last for more than 3 days, or serious allergic reactions during the last immunization with V-01;
- History of obvious allergic reactions or allergic reactions that needed to be medical intervention during the last immunization with V-01;
- After two doses of V-01 inoculation, a newly diagnosed severe chronic disease or the original chronic disease is poorly controlled by drugs (applicable to ≥60 years old): history of chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis) , Hypertension which can not be controlled by drugs (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg), history of severe cardiovascular disease (including heart failure, coronary artery disease, cardiomyopathy), history of chronic kidney disease, history of cancer, diabetes (blood sugar) Unsatisfactory control or serious complications related to diabetes);
- Any confirmed or suspected immunosuppressive or immunodeficiency disorder, including HIV infection and asplenia; recurrent severe infections and administration of immunosuppressive drugs during the past 6 months, excluding topical steroids or short-term oral steroids (<14 days);
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 VaccineAlso: V-01The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection. | Biological | V-01 COVID-19 Vaccine |
Primary outcome
Immunogenicity Endpoints
Time frame: 14 days after booster immunization
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)
1 secondary outcome
Safety Endpoints
Time frame: Day 0-7 after booster immunization, 6 months after booster immunization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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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.
Zhang Jikai principal investigator
Guangdong Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant SARS-CoV-2 Fusion Protein Vaccine in people with COVID19, 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 7 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: finished, as of the sponsor's last update on 25 Apr 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunogenicity Endpoints (time frame: 14 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 25 Apr 2023.