SARS-CoV-2Phase 1NCT06167915
Safety and Immunogenicity of Recombinant COVID-19 Trivalent Protein Vaccine （CHO Cell）LYB002V14 in Booster Vaccination
A Phase 1 study testing 30μg dose of LYB002V14 and 60μg dose of LYB002V14 in people with SARS-CoV-2 and COVID-19 Vaccine, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, blinded, and dose escalation phase I trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19 Vaccine
- What is being tested?
- 30μg dose of LYB002V14 and 60μg dose of LYB002V14
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2023to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18 years and above when screening.
- Participate voluntarily and sign an informed consent form and have the ability to understand research procedures.
- Negative SARS-CoV-2 nucleic acid test and SARS-CoV-2 IgM test.
- Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment.
- Without a history of SARS-CoV-2 infection or known SARS-CoV-2 infection more than 3 months prior to screening.
- Fertile women take effective contraceptive measures 1 month before enrollment; Fertile women (except those received hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy) and men of childbearing potential voluntarily agree to take effective contraceptive measures from screening to 3 months after vaccination and without a plan of pregnancy and germ cell donation.
Who cannot join
- Have a known allergy, hypersensitivity, or intolerance to the planned investigational vaccine including any excipients of the vaccine. Have a known anaphylactic shock and other serious adverse events to other vaccine.
- Have a known history of SARS and MERS.
- Administration of antipyretics, painkillers or anti-allergy drugs within 24 hours prior to enrolment.
- Receipt of subunit and/or inactivated vaccine within 7 days prior to vaccination or receipt of any live attenuated vaccine within 14 days prior to vaccination.
- History of SARS-CoV-2 vaccination within 3 months prior to enrollment; Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study.
- Participants with the following diseases: ①Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment. ②Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. ③Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (>14 immunosuppressive agents within the past 6 months with exception of inhaled or topical steroids, or short-term use （≤14 consecutive days） of oral corticosteroids. ④Currently suffering from or diagnosed with infectious diseases, or positive screening results for human immunodeficiency virus antibody. ⑤History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders. ⑥Asplenia, or functional asplenia. ⑦Presence of severe, uncontrollable or hospitalized cardiovascular diseases, diabetes, blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors. ⑧Contraindications to IM injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage. ⑨Hypertension not controlled by medication (on-site measurement: systolic blood pressure ≥ 160mmHg and / or diastolic blood pressure ≥ 100mmHg).
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- Have a history of major surgery within 3 months before enrollment （based on the judgment of the researchers）, or has not yet fully recovered from the surgery, or has a major surgical plan during the study.
- Those participating or planning to participate in other clinical trials during the study period.
- Those unsuitable for participating in the clinical trial as determined by the investigator because of other abnormalities that are likely to confuse or confound the study results, or non-conformance with the maximal benefits of the participants.
- Exclusion criteria for selected populations: those who are pregnant or breast-feeding or women of childbearing potential have a positive pregnancy test prior to vaccination.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Second University Hospital, Sichuan University
Chengdu, Sichuan
Qin Yu, Master, 18980602109, 908929936@qq.com
About this study
Official title: A Randomized, Blinded, Placebo-Controlled, Dose Escalation Phase 1 Trial of Recombinant COVID-19 Trivalent (XBB.1+BQ.1.1+Prototype) Protein Vaccine （CHO Cell）（LYB002V14） in Booster Vaccination in Participants Aged 18 Years Old and Above
This is a randomized, blinded, and dose escalation phase I trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of Recombinant COVID-19 Trivalent (XBB.1+BQ.1.1+Prototype) Protein Vaccine （CHO Cell）（LYB002V14）.
Read the detailed description
The study is a randomized, blinded and dose escalation Phase I clinical trial. It will evaluate the safety and immunogenicity of 2 dose levels of recombinant COVID-19 trivalent (XBB.1+BQ.1.1+Prototype) protein vaccine （CHO Cell）（LYB002V14）in booster vaccination. Approximately 120 participants aged 18 years and older will be enrolled in this study. The subjects in each dose group will randomly receive an intramuscular （IM） injection of experimental vaccine or placebo on Days 0 in the deltoid muscle at 2:1 and will be followed through 12 months post vaccination.
- Conditions
- SARS-CoV-2, COVID-19 Vaccine
- Being tested
- 30μg dose of LYB002V14, 60μg dose of LYB002V14, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30μg dose of LYB002V14Biological
30μg dose of LYB002V14 vaccine IM, on day 0
60μg dose of LYB002V14Biological
60μg dose of LYB002V14 vaccine IM, on day 0
placeboBiological
placebo IM, on day 0
| Study group | Role | What they receive |
|---|---|---|
| Low dose vaccine group | Experimental | 30μg dose of LYB002V14 vaccine IM, on day 0. Receives: Biological: 30μg dose of LYB002V14 |
| High dose vaccine group | Experimental | 60μg dose of LYB002V14 vaccine IM, on day 0. Receives: Biological: 60μg dose of LYB002V14 |
| Placebo group | Placebo comparator | placebo IM, on day 0. Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and adverse reactions
Statistical description of solicited and unsolicited adverse events （AEs） will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups.
Measured: Day 0 to Day 7
Secondary outcomes (7)
Adverse events and adverse reactions
Statistical description of solicited and unsolicited adverse events （AEs） will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups.
Measured: Day 0 to Day 28
Serious Adverse Events （SAEs） and Adverse Events of Special Interest （AESI）
Statistical description of Serious Adverse Events （SAEs） and Adverse Events of Special Interest （AESI） will be listed. Frequencies and percentages of SAEs and AESI, related to vaccination will be followed during the whole observation.
Measured: Day 0 to Month 12
Laboratory test and vital signs related adverse events.
Indicator of Laboratory test and vital signs related adverse events will be evaluated with three days after booster vaccination.
Measured: Day 0 to Day 3
Geometric mean titer （GMT）, Geometric Mean Fold Rise （GMFR） and seroconversion rate （SCR） of neutralizing antibodies （nAb） against variants of concern circulating during the trial.
The Seroconversion （SCRs） with Clopper-Pearson 95% CIs of neutralizing antibodies （Nabs） against circulating VOCs using Vesicular stomatitis virus （VSV）-based pseudovirus neutralizing assays, at Day 14、Day 28、Month 3 and Month 6 after booster immunization will be calculated for each group, compared with the baseline.
Measured: Day 14、Day 28、Month 3 and Month 6
GMT, GMFR and SCR of nAb against Omicron subvariant （XBB）
The Seroconversion （SCRs） with Clopper-Pearson 95% CIs of neutralizing antibodies （Nabs） against Omicron subvariant （XBB） using Vesicular stomatitis virus （VSV）-based pseudovirus neutralizing assays, at Day 14、Day 28、Month 3 and Month 6 after booster immunization will be calculated for each group, compared with the baseline.
Measured: Day 14、Day 28、Month 3 and Month 6
Geometric Mean Concentration （GMC）, GMFR and SCR of SARS-CoV-2 Spike protein binding antibody.
Geometric Mean Concentration（GMC）, GMFR and SCR with Clopper-Pearson 95% CIs of S protein-binding antibodies using ELISA assays, at baseline, at Day 14、Day 28、Month 3 and Month 6 after the booster immunization will be calculated for each group, compared with the baseline.
Measured: Day 14、Day 28、Month 3 and Month 6
Th1 and Th2 cytokine responses
The counts of spot forming cells （SFCs） per 3×10^5 peripheral blood mononuclear cells （PBMCs） of Cellular immunity RBD-specific IFN-γ and IL-4 cytokine levels at baseline, Day 14 and Month 6 after booster vaccination.
Measured: Day 14 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start26 Dec 2023 (estimated)
- Primary completion26 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yantai Patronus Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Qin Yu, Master, Principal investigator, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167915
- Sponsor's protocol ID
- LYB002V14/CT-CHN-101
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-Controlled, Dose Escalation Phase 1 Trial of Recombinant COVID-19 Trivalent (XBB.1+BQ.1.1+Prototype) Protein Vaccine （CHO Cell）（LYB002V14） in Booster Vaccination in Participants Aged 18 Years Old and Above
- ClinicalTrials.gov ID
- NCT06167915
- Acronym / sponsor ID
- LYB002V14/CT-CHN-101
- Conditions
- SARS-CoV-2, COVID-19 Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Yantai Patronus Biotech Co., Ltd.
- Study start
- 26 Dec 2023 (estimated)
- Primary completion
- 26 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Dec 2023 (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 is a randomized, blinded, and dose escalation phase I trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of Recombinant COVID-19 Trivalent (XBB.1+BQ.1.1+Prototype) Protein Vaccine （CHO Cell）（LYB002V14）.
Detailed description
The study is a randomized, blinded and dose escalation Phase I clinical trial. It will evaluate the safety and immunogenicity of 2 dose levels of recombinant COVID-19 trivalent (XBB.1+BQ.1.1+Prototype) protein vaccine （CHO Cell）（LYB002V14）in booster vaccination. Approximately 120 participants aged 18 years and older will be enrolled in this study. The subjects in each dose group will randomly receive an intramuscular （IM） injection of experimental vaccine or placebo on Days 0 in the deltoid muscle at 2:1 and will be followed through 12 months post vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose vaccine group | Experimental | Biological: 30μg dose of LYB002V1430μg dose of LYB002V14 vaccine IM, on day 0. |
| High dose vaccine group | Experimental | Biological: 60μg dose of LYB002V1460μg dose of LYB002V14 vaccine IM, on day 0. |
| Placebo group | Placebo comparator | Biological: placeboplacebo IM, on day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged 18 years and above when screening.
- Participate voluntarily and sign an informed consent form and have the ability to understand research procedures.
- Negative SARS-CoV-2 nucleic acid test and SARS-CoV-2 IgM test.
- Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment.
- Without a history of SARS-CoV-2 infection or known SARS-CoV-2 infection more than 3 months prior to screening.
Key exclusion criteria (10 listed)
- Have a known allergy, hypersensitivity, or intolerance to the planned investigational vaccine including any excipients of the vaccine. Have a known anaphylactic shock and other serious adverse events to other vaccine.
- Have a known history of SARS and MERS.
- Administration of antipyretics, painkillers or anti-allergy drugs within 24 hours prior to enrolment.
- Receipt of subunit and/or inactivated vaccine within 7 days prior to vaccination or receipt of any live attenuated vaccine within 14 days prior to vaccination.
- History of SARS-CoV-2 vaccination within 3 months prior to enrollment; Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study.
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 |
|---|---|---|
| 30μg dose of LYB002V1430μg dose of LYB002V14 vaccine IM, on day 0 | Biological | Low dose vaccine group |
| 60μg dose of LYB002V1460μg dose of LYB002V14 vaccine IM, on day 0 | Biological | High dose vaccine group |
| placeboplacebo IM, on day 0 | Biological | Placebo group |
Primary outcome
Adverse events and adverse reactions
Time frame: Day 0 to Day 7
Statistical description of solicited and unsolicited adverse events （AEs） will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups.
7 secondary outcomes
Adverse events and adverse reactions
Time frame: Day 0 to Day 28
Serious Adverse Events （SAEs） and Adverse Events of Special Interest （AESI）
Time frame: Day 0 to Month 12
Laboratory test and vital signs related adverse events.
Time frame: Day 0 to Day 3
Geometric mean titer （GMT）, Geometric Mean Fold Rise （GMFR） and seroconversion rate （SCR） of neutralizing antibodies （nAb） against variants of concern circulating during the trial.
Time frame: Day 14、Day 28、Month 3 and Month 6
GMT, GMFR and SCR of nAb against Omicron subvariant （XBB）
Time frame: Day 14、Day 28、Month 3 and Month 6
Geometric Mean Concentration （GMC）, GMFR and SCR of SARS-CoV-2 Spike protein binding antibody.
Time frame: Day 14、Day 28、Month 3 and Month 6
Th1 and Th2 cytokine responses
Time frame: Day 14 and Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Qin Yu, Master principal investigator
West China Second University Hospital
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 30μg dose of LYB002V14 and 60μg dose of LYB002V14 in people with SARS-CoV-2 and COVID-19 Vaccine, run by Guangzhou Patronus Biotech Co., Ltd. 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 10 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 26 Dec 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Yu, Master (18980602109, 908929936@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and adverse reactions (time frame: Day 0 to Day 7). 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 26 Dec 2023.