COVID-19 PandemicEarly Phase 1COVID-19NCT05583357
Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351
A Early Phase 1 study testing V-01D-351 and CoronaVac 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, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster. 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?
- V-01D-351 and CoronaVac
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2022to 10 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older at time of consent, male or female;
- Normal body temperature;
- Meet either of the following conditions:
- Received completed primary immunization of 2 doses of CoronaVac 6-15 months ago;
- Received completed 3 doses of CoronaVac 5-9 months ago;
- 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, Blind Endpoint Evaluation, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 as a Booster Dose in Participants Aged 18 Years and Older Vaccinated 2-dose or 3-dose Inactivated COVID-19 Vaccine
It is a single center, randomized, open-labeled, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster.
- Conditions
- COVID-19 Pandemic
- Being tested
- V-01D-351, CoronaVac
- 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-01D-351Biological
One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
V-01D-351Biological
One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
CoronaVacBiological
One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
CoronaVacBiological
One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Biological: V-01D-351 |
| Cohort 2 | Experimental | Not described Receives: Biological: V-01D-351 |
| Cohort 3 | Active comparator | Not described Receives: Biological: CoronaVac |
| Cohort 4 | Active comparator | Not described Receives: Biological: CoronaVac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibody 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 (9)
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: 7 days, 14 days, 28 days, 3 months, 6 months and 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: 7 days, 14 days, 28 days, 3 months, 6 months and 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: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Total IgG antibody level
Total IgG antibody level of SARS-CoV-2
Measured: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Spike protein antibody level
Antibody level of anti-SARS-CoV-2 spike protein
Measured: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
RBD antibody level
Anti-SARS-CoV-2 RBD antibody level
Measured: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Specific cytokine secretion levels
Specific cytokine secretion levels such as IFN-γ
Measured: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
AEs
Observe the AEs occurs at different time point after vaccination
Measured: 30 minutes, 0-7 days, 0-28 days after vaccination
SAE and AESI
Observe the SAE and AESI after vaccination
Measured: Within 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 posted17 Oct 2022
- Study start15 Aug 2022
- Primary completion13 Sep 2022
- Study completion10 Aug 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
- 40 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
- NCT05583357
- Sponsor's protocol ID
- V-01D-351-Booster-03
- Acronym
- COVID-19
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 19 Oct 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 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open-labeled, Blind Endpoint Evaluation, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 as a Booster Dose in Participants Aged 18 Years and Older Vaccinated 2-dose or 3-dose Inactivated COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05583357
- Acronym / sponsor ID
- COVID-19 / V-01D-351-Booster-03
- Conditions
- COVID-19 Pandemic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 10 Aug 2023 (estimated)
- First posted
- 17 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, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: V-01D-351 |
| Cohort 2 | Experimental | Biological: V-01D-351 |
| Cohort 3 | Active comparator | Biological: CoronaVac |
| Cohort 4 | Active comparator | Biological: CoronaVac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years and older at time of consent, male or female;
- Normal body temperature;
- Meet either of the following conditions:
- 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-01D-351One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago | Biological | Cohort 1 |
| V-01D-351One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago | Biological | Cohort 2 |
| CoronaVacOne dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago | Biological | Cohort 3 |
| CoronaVacOne dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago | Biological | Cohort 4 |
Primary outcome
Neutralizing antibody 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)
9 secondary outcomes
Neutralizing antibody GMT of other SARS-CoV-2 variants
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Total IgG antibody level
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Spike protein antibody level
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
RBD antibody level
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Specific cytokine secretion levels
Time frame: 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
AEs
Time frame: 30 minutes, 0-7 days, 0-28 days after vaccination
SAE and AESI
Time frame: Within 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 19 Oct 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-01D-351 and CoronaVac 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 8 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 19 Oct 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?
Neutralizing antibody GMT of Omicron BA.5 (time frame: 28 days after vaccination). 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 19 Oct 2022.