COVID-19Phase 2/3NCT05602558
The Phase Ⅱ/Ⅲ Trial of LYB001
A Phase 2/3 study testing LYB001 in people with COVID-19, run by Yantai Patronus Biotech Co., Ltd..
Trial summary
The study will be conducted in two phases using a randomized, double-blind, placebo-controlled design. A phase II trial will be initiated to assess the safety of LYB001 as booster shots, and then proceed to a phase III trial to assess the vaccine efficacy (VE) of LYB001 against COVID-19 after an acceptable safety… 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Feb 2024
- Phase
- Phase 2/3
- 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, including both males and females;
- 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.
- Subjects who have been vaccinated with two-dose or three-dose inactivated COVID-19 vaccine for6-18 months (including boundary values).
- 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.).
Who cannot join
- Receipt of any COVID-19 prophylactic medication other than inactivated COVID-19 vaccine (e.g., receipt history of any approved or under developing COVID-19 vaccines, or other COVID-19 prophylactic medication, etc.), or previous vaccination history other than other than two- or three-dose inactivated COVID-19 vaccination;
- Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (for subjects with poorly controlled blood pressure), or axillary body temperature ≥ 37.3°C prior to enrolment;
- Known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;
- History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
- History of COVID-19, or positive results for SARS-CoV-2 nucleic acid or antigen tests at screening;
- Receipt of any live attenuated vaccine within 28 days prior to vaccination, and other vaccines such as subunit and inactivated vaccine within 14 days prior to vaccination;
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- Receipt of blood or blood-related products, including immunoglobulins, monoclonal antibodies, 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 diagnosed with infectious diseases, such as hepatitis B, hepatitis C, syphilis, AIDS etc.；
- History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders；
- Asplenia, or functional asplenia；
- Presence of severe, uncontrollable or hospitalized cardiovascular diseases, endocrine diseases, 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;
- Pregnant or lactating females;
- Having participated or participating in COVID-19 related clinical trials, and those 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.
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Older Completed Two-dose or Three-dose Inactivated COVID-19 Vaccine
The study will be conducted in two phases using a randomized, double-blind, placebo-controlled design. A phase II trial will be initiated to assess the safety of LYB001 as booster shots, and then proceed to a phase III trial to assess the vaccine efficacy (VE) of LYB001 against COVID-19 after an acceptable safety profile, per the judgement of Data and Safety Monitoring Board (DSMB), within 28 days after booster in the phase Ⅱ trial is assessed. After collection of 155 COVID-19 cases, all participants will get unblinded. Participants assigned to the placebo group can choose to receive LYB001 vaccine at their own discretion.
Phase II stage:
Read more
The purpose of phase Ⅱ study is to assess the safety of healthy subjects aged 18 years and older who have completed two-dose or three-dose inactivated COVID-19 vaccine for 6-18 months. About 200 age s-stratified subjects aged over 18 years will be randomly assigned to receive the LYB001 or placebo in a 1:1 ratio in the deltoid muscle of the upper arm.
The Phase III study will be initiated after the DSMB confirm that all subjects in Phase II experience acceptable safety profile within 28 days after booster. All subjects in Phase II trial will be required to complete efficacy follow-ups for 12 months along with safety observation, and will be included in the Phase III efficacy analysis set (Phase II data will eventually be combined with Phase III data for statistical analysis, including efficacy and safety data).
Phase III stage:
A total of 17800 participants aged 18 years and older who have completed two-dose or three-dose inactivated COVID-19 vaccine for 6-18 months. The participants will be randomly assigned to the LYB001 booster or placebo booster group in 1:1 ratio according stratification factors of study center and age (18-59 years vs. ≥60 years) , with participants aged ≥ 60 years accounting for over 20 percent of total population.
After booster vaccination, all subjects will be evaluated for protective efficacy and safety, and 1000 subjects (800 subjects aged 18-59 years, and 200 subjects aged ≥60 years) will be enrolled in the subgroup for immunogenicity evaluation (LYB001: Placebo=1:1).
All subjects will be followed up to 12 months after booster vaccination. The entire clinical study will be completed after the pre-defined COVID-19 cases has been achieved and each participant has completed 12-month follow-ups.
- 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 antigen consists of receptor-binding domain (RBD) from wild-type SARS-CoV-2 displaying on virus-like particle (VLP) vector, adjuvanted with aluminium hydroxide.
PlaceboBiological
Aluminium hydroxide adjuvant
| Study group | Role | What they receive |
|---|---|---|
| LYB001 | Experimental | Not described Receives: Biological: LYB001 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of confirmed symptomatic COVID-19 incidence rate per person-years of follow-up
Measured: 14 days after the booster
Secondary outcomes (6)
First occurrence of confirmed severe, critical, and fatal COVID-19 incidence per person-years of follow-up
Measured: 14 days after the booster
Solicited local/systemic adverse events
Measured: 7 days after the booster
Unsolicited adverse events
Measured: 28 days after the booster
Geometric mean titers of neutralizing antibodies against wild-type SARS-CoV-2 and circulating variants of concern, S protein-binding antibodies in immunogenicity subgroup
Measured: 14days, 28 days after booster, and 3, 6, 12 months after booster
Geometric mean fold rises of neutralizing antibodies against wild-type SARS-CoV-2 and circulating variants of concern, S protein-binding antibodies in immunogenicity subgroup
Measured: 14days, 28 days after booster, and 3, 6, 12 months after booster
Seroconversion rates of neutralizing antibodies against wild-type SARS-CoV-2 and circulating variants of concern, S protein-binding antibodies in immunogenicity subgroup
Measured: 14days, 28 days after booster, and 3, 6, 12 months after booster
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18,000 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
- NCT05602558
- Sponsor's protocol ID
- LYB001/CT-PAK-301
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Older Completed Two-dose or Three-dose Inactivated COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05602558
- Acronym / sponsor ID
- LYB001/CT-PAK-301
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Yantai Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 2 Nov 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.
The study will be conducted in two phases using a randomized, double-blind, placebo-controlled design. A phase II trial will be initiated to assess the safety of LYB001 as booster shots, and then proceed to a phase III trial to assess the vaccine efficacy (VE) of LYB001 against COVID-19 after an acceptable safety profile, per the judgement of Data and Safety Monitoring Board (DSMB), within 28 days after booster in the phase Ⅱ trial is assessed. After collection of 155 COVID-19 cases, all participants will get unblinded. Participants assigned to the placebo group can choose to receive LYB001 vaccine at their own discretion.
Phase II stage:
The purpose of phase Ⅱ study is to assess the safety of healthy subjects aged 18 years and older who have completed two-dose or three-dose inactivated COVID-19 vaccine for 6-18 months. About 200 age s-stratified subjects aged over 18 years will be randomly assigned to receive the LYB001 or placebo in a 1:1 ratio in the deltoid muscle of the upper arm.
The Phase III study will be initiated after the DSMB confirm that all subjects in Phase II experience acceptable safety profile within 28 days after booster. All subjects in Phase II trial will be required to complete efficacy follow-ups for 12 months along with safety observation, and will be included in the Phase III efficacy analysis set (Phase II data will eventually be combined with Phase III data for statistical analysis, including efficacy and safety data).
Phase III stage:
A total of 17800 participants aged 18 years and older who have completed two-dose or three-dose inactivated COVID-19 vaccine for 6-18 months. The participants will be randomly assigned to the LYB001 booster or placebo booster group in 1:1 ratio according stratification factors of study center and age (18-59 years vs. ≥60 years) , with participants aged ≥ 60 years accounting for over 20 percent of total population.
After booster vaccination, all subjects will be evaluated for protective efficacy and safety, and 1000 subjects (800 subjects aged 18-59 years, and 200 subjects aged ≥60 years) will be enrolled in the subgroup for immunogenicity evaluation (LYB001: Placebo=1:1).
All subjects will be followed up to 12 months after booster vaccination. The entire clinical study will be completed after the pre-defined COVID-19 cases has been achieved and each participant has completed 12-month follow-ups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LYB001 | Experimental | Biological: LYB001 |
| Placebo | Placebo comparator | Biological: Placebo |
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, including both males and females;
- 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.
- Subjects who have been vaccinated with two-dose or three-dose inactivated COVID-19 vaccine for6-18 months (including boundary values).
- 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.).
Key exclusion criteria (20 listed)
- Receipt of any COVID-19 prophylactic medication other than inactivated COVID-19 vaccine (e.g., receipt history of any approved or under developing COVID-19 vaccines, or other COVID-19 prophylactic medication, etc.), or previous vaccination history other than other than two- or three-dose inactivated COVID-19 vaccination;
- Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (for subjects with poorly controlled blood pressure), or axillary body temperature ≥ 37.3°C prior to enrolment;
- Known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;
- History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
- History of COVID-19, or positive results for SARS-CoV-2 nucleic acid or antigen tests 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 antigen consists of receptor-binding domain (RBD) from wild-type SARS-CoV-2 displaying on virus-like particle (VLP) vector, adjuvanted with aluminium hydroxide. | Biological | LYB001 |
| PlaceboAluminium hydroxide adjuvant | Biological | Placebo |
Primary outcome
First occurrence of confirmed symptomatic COVID-19 incidence rate per person-years of follow-up
Time frame: 14 days after the booster
6 secondary outcomes
First occurrence of confirmed severe, critical, and fatal COVID-19 incidence per person-years of follow-up
Time frame: 14 days after the booster
Solicited local/systemic adverse events
Time frame: 7 days after the booster
Unsolicited adverse events
Time frame: 28 days after the booster
Geometric mean titers of neutralizing antibodies against wild-type SARS-CoV-2 and circulating variants of concern, S protein-binding antibodies in immunogenicity subgroup
Time frame: 14days, 28 days after booster, and 3, 6, 12 months after booster
Geometric mean fold rises of neutralizing antibodies against wild-type SARS-CoV-2 and circulating variants of concern, S protein-binding antibodies in immunogenicity subgroup
Time frame: 14days, 28 days after booster, and 3, 6, 12 months after booster
Seroconversion rates of neutralizing antibodies against wild-type SARS-CoV-2 and circulating variants of concern, S protein-binding antibodies in immunogenicity subgroup
Time frame: 14days, 28 days after booster, and 3, 6, 12 months after booster
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 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 20 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 2 Nov 2022. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
First occurrence of confirmed symptomatic COVID-19 incidence rate per person-years of follow-up (time frame: 14 days after the booster). 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 2 Nov 2022.