COVID-19Phase 1NCT05125926
A Phase Ⅰ Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine LYB001
A Phase 1 study testing LYB001 in people with COVID-19, run by Yantai Patronus Biotech Co., Ltd..
Trial summary
This is a randomized, double-blind, placebo-controlled Phase Ⅰ trial in healthy adults aged 18 years and older, intended to evaluate the safety, reactogenicity, and immunogenicity profile of LYB001. 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
- What is being tested?
- LYB001
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Apr 2023
- 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
- Healthy subjects aged 18 years and older;
- Subjects who agree to participate in this clinical trial voluntarily and sign the informed consent form, are capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
- For female participants of childbearing potential, effective contraception measures should be used within 2 weeks prior to participation in this study and the results of pregnancy test is required to be negative. Participants should voluntarily agree to use effective contraceptive measures from the time of signing the informed consent form to the end of the study (effective contraceptive measures including oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).
- Body mass index within range of 18~30 kg/m2.
Who cannot join
- Abnormal results of laboratory screening tests which was clinically significant judged by clinicians;
- Abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or axillary body temperature ≥ 37.3°C;
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;
- History of human coronavirus infection/diseases, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
- History of COVID-19, or history of close contact with confirmed/suspected COVID-19 patients, or positive results for either SARS-CoV-2 nucleic acid or antibody tests (IgG and IgM) at screening;
- Administration of antipyretics or painkillers within 24 hours prior to vaccination;
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- Receipt of any COVID-19 vaccine, live attenuated vaccine within 28 days prior to vaccination and other vaccines, such as subunit and inactived vaccine within 14 days prior to vaccination;
- Receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned use during the study period.
- Subjects with the following diseases:
- Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment；
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.；
- Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids；
- Currently suffering from or previously diagnosed with infectious diseases, positive screening results for hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, human immunodeficiency virus antibody；
- History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders；
- Asplenia, or functional asplenia；
- Presence of severe, uncontrollable or hospitalization indicated cardiovascular diseases, diabetes, neurological diseases (e.g., Guillain-Barre syndrome), blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors;
- Contraindications to IM injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage.
- Drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures;
- History of a major surgery, per the investigator's judgment, within 12 weeks before vaccination, or not achieving full recovery after surgery, or any planned major surgery during the study;
- Pregnant or lactating females, or those who plan to become pregnant during the study period;
- Having participated or being participating in COVID-19 related clinical trials, and those being participating or planning to participate in other clinical trials during the study period;
- Presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine LYB001 in Healthy Adults: a Randomized, Double Blinded, Placebo-controlled Phase Ⅰ Trial
This is a randomized, double-blind, placebo-controlled Phase Ⅰ trial in healthy adults aged 18 years and older, intended to evaluate the safety, reactogenicity, and immunogenicity profile of LYB001. The study vaccine will be administered IM at upper arm deltoid as a three-dose regimen with 28d interval on day 0, 28, 56.
To ensure the safety of the participants, the phase Ⅰ trial was will be carried out in a dose-escalation and age-sequential enrolment manner:
Read more
- The safety, reactogenicity, and immunogenicity will be firstly evaluated in a cohort of adults aged 18-59 years randomly assigned (4:1) either to receive low-dose (25µg) LYB001 or placebo. After confirmation of an favorable 7-day safety, reactogenicity profile in this cohort by investigator, the study was able to proceed to the cohort of adults aged 18-59 years receiving high-dose (50µg) LYB001 or placebo.
- After completing a favorable 7-day safety observation following the first dose of 50μg LYB001 in cohorts aged 18-59 years, the study was able to advance to cohorts aged ≥ 60 years receiving low-dose (25µg) LYB001 or placebo.
By analogy, all dose and age-stratified groups will be sequentially enrolled. The study will be ended after all participants completed 360-day safety observation following the 3rd dose of vaccination.
- Conditions
- COVID-19
- Being tested
- LYB001, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYB001Biological
The investigational vaccine, with its antigen consisting of receptor-binding domain (RBD) from SARS-CoV-2 and virus-like particle (VLP) vector, adjuvanted with aluminum hydroxide. The investigational are administered through Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56.
PlaceboBiological
Aluminum hydroxide
| Study group | Role | What they receive |
|---|---|---|
| low-dose LYB001 in participants aged 18-59 years | Experimental | Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 Receives: Biological: LYB001 |
| Placebo comparator Ⅰ in participants aged 18-59 years | Placebo comparator | Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 Receives: Biological: Placebo |
| high-dose LYB001 in participants aged 18-59 years | Experimental | Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 Receives: Biological: LYB001 |
| Placebo comparator Ⅱ in participants aged 18-59 years | Placebo comparator | Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 Receives: Biological: Placebo |
| low-dose LYB001 in participants aged over 60 years | Experimental | Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 Receives: Biological: LYB001 |
| Placebo comparator Ⅲ in participants aged over 60 years | Placebo comparator | Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 Receives: Biological: Placebo |
| high-dose LYB001 in participants aged over 60 years | Experimental | Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 Receives: Biological: LYB001 |
| Placebo comparator Ⅳ in participants aged over 60 years | Placebo comparator | Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Immediate adverse events (AEs) within 30 minutes after each vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following each vaccination;1. Immediate adverse events (AEs) within 30 minutes after each vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following each vaccination;
Measured: 28 days after each dose
Secondary outcomes (6)
Serious adverse events (SAEs)
Serious adverse events (SAEs) throughout the study
Measured: 360 days after first vaccination
Safety laboratory measures
Changes of safety laboratory measures and vital signs at day 3 following each vaccination in comparison to pre-vaccination levels.
Measured: 3 days after each dose
Geometric neutralizing titers (GMT), Geometric Mean Increases (GMI) and seroconversion rates against wild-type SARS-CoV-2
Geometric neutralizing titers (GMT), Geometric Mean Increases (GMI) and seroconversion rates against wild-type SARS-CoV-2
Measured: pre dose 1, day 14 post dose 2, day 14, 28 post dose 3
GMT, GMI and seroconversion rates against SARS-CoV-2 variants of concern (VOCs)
GMT, GMI and seroconversion rates against SARS-CoV-2 variants of concern (VOCs)
Measured: pre dose 1, day 14 post dose 2, day 14, 28 post dose 3
GMT, GMI and seroconversion rates of S protein-binding antibodies
GMT, GMI and seroconversion rates of S protein-binding antibodies
Measured: pre dose 1, day 14 post dose 2, day 14, 28 post dose 3
Cellular Immune Response
- Th1 and Th2 immune responses by enzyme-linked immunospot (ELISPOT) assay, Th1: interferon gamma (IFN-γ), interleukin-2 (IL-2), Th2: IL-4, IL-6.
Measured: pre dose 1, day 14 post dose 2, day 14 dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study startDec 2021 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai Patronus Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125926
- Sponsor's protocol ID
- LYB001/CT-LAO-101
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 18 Nov 2021
- 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 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine LYB001 in Healthy Adults: a Randomized, Double Blinded, Placebo-controlled Phase Ⅰ Trial
- ClinicalTrials.gov ID
- NCT05125926
- Acronym / sponsor ID
- LYB001/CT-LAO-101
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yantai Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2021 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 18 Nov 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 is a randomized, double-blind, placebo-controlled Phase Ⅰ trial in healthy adults aged 18 years and older, intended to evaluate the safety, reactogenicity, and immunogenicity profile of LYB001. The study vaccine will be administered IM at upper arm deltoid as a three-dose regimen with 28d interval on day 0, 28, 56.
To ensure the safety of the participants, the phase Ⅰ trial was will be carried out in a dose-escalation and age-sequential enrolment manner:
- The safety, reactogenicity, and immunogenicity will be firstly evaluated in a cohort of adults aged 18-59 years randomly assigned (4:1) either to receive low-dose (25µg) LYB001 or placebo. After confirmation of an favorable 7-day safety, reactogenicity profile in this cohort by investigator, the study was able to proceed to the cohort of adults aged 18-59 years receiving high-dose (50µg) LYB001 or placebo.
- After completing a favorable 7-day safety observation following the first dose of 50μg LYB001 in cohorts aged 18-59 years, the study was able to advance to cohorts aged ≥ 60 years receiving low-dose (25µg) LYB001 or placebo.
By analogy, all dose and age-stratified groups will be sequentially enrolled. The study will be ended after all participants completed 360-day safety observation following the 3rd dose of vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| low-dose LYB001 in participants aged 18-59 years | Experimental | Biological: LYB001Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 |
| Placebo comparator Ⅰ in participants aged 18-59 years | Placebo comparator | Biological: PlaceboIntramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 |
| high-dose LYB001 in participants aged 18-59 years | Experimental | Biological: LYB001Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 |
| Placebo comparator Ⅱ in participants aged 18-59 years | Placebo comparator | Biological: PlaceboIntramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 |
| low-dose LYB001 in participants aged over 60 years | Experimental | Biological: LYB001Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 |
| Placebo comparator Ⅲ in participants aged over 60 years | Placebo comparator | Biological: PlaceboIntramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 |
| high-dose LYB001 in participants aged over 60 years | Experimental | Biological: LYB001Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 |
| Placebo comparator Ⅳ in participants aged over 60 years | Placebo comparator | Biological: PlaceboIntramuscular injection (IM) at upper arm deltoid on day 0, 28, 56 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects aged 18 years and older;
- Subjects who agree to participate in this clinical trial voluntarily and sign the informed consent form, are capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
- For female participants of childbearing potential, effective contraception measures should be used within 2 weeks prior to participation in this study and the results of pregnancy test is required to be negative. Participants should voluntarily agree to use effective contraceptive measures from the time of signing the informed consent form to the end of the study (effective contraceptive measures including oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).
- Body mass index within range of 18~30 kg/m2.
Key exclusion criteria (22 listed)
- Abnormal results of laboratory screening tests which was clinically significant judged by clinicians;
- Abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or axillary body temperature ≥ 37.3°C;
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;
- History of human coronavirus infection/diseases, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
- History of COVID-19, or history of close contact with confirmed/suspected COVID-19 patients, or positive results for either SARS-CoV-2 nucleic acid or antibody tests (IgG and IgM) at screening;
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 |
|---|---|---|
| LYB001The investigational vaccine, with its antigen consisting of receptor-binding domain (RBD) from SARS-CoV-2 and virus-like particle (VLP) vector, adjuvanted with aluminum hydroxide. The investigational are administered through Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56. | Biological | high-dose LYB001 in participants aged 18-59 years, high-dose LYB001 in participants aged over 60 years, low-dose LYB001 in participants aged 18-59 years, low-dose LYB001 in participants aged over 60 years |
| PlaceboAluminum hydroxide | Biological | Placebo comparator Ⅰ in participants aged 18-59 years, Placebo comparator Ⅱ in participants aged 18-59 years, Placebo comparator Ⅲ in participants aged over 60 years, Placebo comparator Ⅳ in participants aged over 60 years |
Primary outcome
Adverse events
Time frame: 28 days after each dose
Immediate adverse events (AEs) within 30 minutes after each vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following each vaccination;1. Immediate adverse events (AEs) within 30 minutes after each vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following each vaccination;
6 secondary outcomes
Serious adverse events (SAEs)
Time frame: 360 days after first vaccination
Safety laboratory measures
Time frame: 3 days after each dose
Geometric neutralizing titers (GMT), Geometric Mean Increases (GMI) and seroconversion rates against wild-type SARS-CoV-2
Time frame: pre dose 1, day 14 post dose 2, day 14, 28 post dose 3
GMT, GMI and seroconversion rates against SARS-CoV-2 variants of concern (VOCs)
Time frame: pre dose 1, day 14 post dose 2, day 14, 28 post dose 3
GMT, GMI and seroconversion rates of S protein-binding antibodies
Time frame: pre dose 1, day 14 post dose 2, day 14, 28 post dose 3
Cellular Immune Response
Time frame: pre dose 1, day 14 post dose 2, day 14 dose 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYB001 in people with COVID-19, run by Yantai Patronus Biotech Co., Ltd..
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 22 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 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Jingwen Qu (+86 15626903973, qujingwen@luye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 28 days after each dose). 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 18 Nov 2021.