COVID-19 PandemicEarly Phase 1COVID-19NCT05585567
A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5
A Early Phase 1 study testing V-01/V-01-B5, V-01-351/V-01-B5 and V-01 in people with COVID-19 Pandemic, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial summary
It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- V-01/V-01-B5, V-01-351/V-01-B5 and V-01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2022to 11 Sep 2023
- Phase
- Early 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 -59 years old at time of consent, male or female;
- Normal body temperature;
- Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;
- Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
- Be able and willing to complete the study during the entire study and follow-up period;
- Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.
Who cannot join
- Serious chronic diseases or uncontrolled diseases;
- Uncontrolled neurological disorders, epilepsy;
- Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
- Patients with congenital or acquired immunodeficiency;
- History of severe allergy or be allergic to any components of the test vaccines;
- History of hereditary hemorrhagic tendency or coagulation dysfunction;
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- Patients with malignant tumors and other patients have a life expectancy less than 1 year;
- Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
- History of previous COVID-19 infection;
- Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;
- Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;
- 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 Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine
It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.
- Conditions
- COVID-19 Pandemic
- Being tested
- V-01/V-01-B5, V-01-351/V-01-B5, V-01
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-01/V-01-B5Biological
Contains 10μg of V-01 and 10μg of V-01-B5
V-01-351/V-01-B5Biological
Contains 10μg of V-01-351 and 10μg of V-01-B5
V-01Biological
Contains 10μg of V-01
| Study group | Role | What they receive |
|---|---|---|
| V-01/V-01-B5 group | Experimental | One dose of V-01/V-01-B5 Receives: Biological: V-01/V-01-B5 |
| V-01-351/V-01-B5 group | Experimental | One dose of V-01-351/V-01-B5 Receives: Biological: V-01-351/V-01-B5 |
| V-01 group | Experimental | One dose of V-01 Receives: Biological: V-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE)
Observe the AEs occurs at different time point after vaccination
Measured: 30 minutes after vaccination
AEs
Observe the AEs occurs at different time point after vaccination
Measured: 0-7 days after vaccination
AEs
Observe the AEs occurs at different time point after vaccination
Measured: 0-28 days after vaccination
Serious adverse event (SAE) and adverse event of special interest (AESI)
Observe the SAE and AESI after vaccination
Measured: Within 12 months after vaccination
Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5
Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)
Measured: 28 days after vaccination
Secondary outcomes (4)
Neutralizing antibody GMT of other SARS-CoV-2 variants
Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5)
Measured: Until 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)
Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT
Measured: Until 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)
Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT
Measured: Until 12 months after vaccination
Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level
Anti-SARS-CoV-2 RBD antibody level after vaccination
Measured: Until 12 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start16 Sep 2022
- Primary completion14 Oct 2022
- Study completion11 Sep 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585567
- Sponsor's protocol ID
- V-01-B5- Booster-01
- Acronym
- COVID-19
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 7 Nov 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 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05585567
- Acronym / sponsor ID
- COVID-19 / V-01-B5- Booster-01
- Conditions
- COVID-19 Pandemic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 11 Sep 2023 (estimated)
- First posted
- 19 Oct 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.
It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V-01/V-01-B5 group | Experimental | Biological: V-01/V-01-B5One dose of V-01/V-01-B5 |
| V-01-351/V-01-B5 group | Experimental | Biological: V-01-351/V-01-B5One dose of V-01-351/V-01-B5 |
| V-01 group | Experimental | Biological: V-01One dose of V-01 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18 -59 years old at time of consent, male or female;
- Normal body temperature;
- Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;
- Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
- Be able and willing to complete the study during the entire study and follow-up period;
Key exclusion criteria (12 listed)
- Serious chronic diseases or uncontrolled diseases;
- Uncontrolled neurological disorders, epilepsy;
- Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
- Patients with congenital or acquired immunodeficiency;
- History of severe allergy or be allergic to any components of the test vaccines;
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 |
|---|---|---|
| V-01/V-01-B5Contains 10μg of V-01 and 10μg of V-01-B5 | Biological | V-01/V-01-B5 group |
| V-01-351/V-01-B5Contains 10μg of V-01-351 and 10μg of V-01-B5 | Biological | V-01-351/V-01-B5 group |
| V-01Contains 10μg of V-01 | Biological | V-01 group |
Primary outcome
Adverse Event (AE)
Time frame: 30 minutes after vaccination
Observe the AEs occurs at different time point after vaccination
AEs
Time frame: 0-7 days after vaccination
Observe the AEs occurs at different time point after vaccination
AEs
Time frame: 0-28 days after vaccination
Observe the AEs occurs at different time point after vaccination
Serious adverse event (SAE) and adverse event of special interest (AESI)
Time frame: Within 12 months after vaccination
Observe the SAE and AESI after vaccination
Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5
Time frame: 28 days after vaccination
Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)
4 secondary outcomes
Neutralizing antibody GMT of other SARS-CoV-2 variants
Time frame: Until 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)
Time frame: Until 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)
Time frame: Until 12 months after vaccination
Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level
Time frame: Until 12 months after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing V-01/V-01-B5, V-01-351/V-01-B5 and V-01 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 6 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 7 Nov 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Adverse Event (AE) (time frame: 30 minutes after vaccination). The study lists 5 primary outcomes in all. 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 7 Nov 2022.