COVID-19Phase 3NCT05664932
Immunogenicity and Safety of COVID-19 Vaccine as a Booster Vaccination in Population Aged 18 Years and Above
A Phase 3 study testing Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 and ZF2001 in people with COVID-19, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.
Trial summary
A total of 1200 people aged 18 years and older who have completed two or three-dose inactivated COVID-19 vaccine for 6-18 months will be recruited in this study. Subjects will be received 1 dose at day 0 as a booster vaccination.Immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 will be… 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?
- Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 and ZF2001
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2022to 31 Dec 2023
- Phase
- Phase 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 for 6-18 months .
- 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 two- or three-dose inactivated COVID-19 vaccination;
- Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg 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 close contact with a confirmed/suspected COVID-19 patient or positive results for SARS-CoV-2 nucleic acid ;
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei
About this study
Official title: Evaluate the Immunogenicity and Safety of a Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Above Who Have Completed Two-dose or Three-dose Inactivated COVID-19 Vaccine
A total of 1200 people aged 18 years and older who have completed two or three-dose inactivated COVID-19 vaccine for 6-18 months will be recruited in this study. Subjects will be received 1 dose at day 0 as a booster vaccination.Immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 will be evaluated.
Read the detailed description
The study is a randomized, double-blind, positive control design and 1200 subjects are randomly assigned to LYB001 and positive control groups in a 1:1 ratio to evaluate the safety and immunogenicity as a booster vaccination.
- Conditions
- COVID-19
- Being tested
- Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, ZF2001
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001Biological
Intramuscular injection of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.
ZF2001Biological
Intramuscular injection of ZF2001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.
| Study group | Role | What they receive |
|---|---|---|
| LYB001 Booster Group | Experimental | Subjects 18 years of age or older who has completed two or three-dose inactivated COVID-19 will receive 30μg LYB001 at day 0 as a booster vaccination. Receives: Biological: Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 |
| ZF2001 Booster Group | Active comparator | Subjects 18 years of age or older who has completed two or three-dose inactivated COVID-19 will receive ZF2001 at day 0 as a booster vaccination. Receives: Biological: ZF2001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric neutralizing titers (GMT) of neutralizing antibody against variants of concern(VOCs)
Geometric neutralizing titers (GMT) of neutralizing antibody against variants of concern(VOCs) at day 14 after booster vaccination in cohort 1.
Measured: Day 14 after booster vaccination
Secondary outcomes (8)
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14, day 28, month 6 after booster vaccination in cohort 1.
Measured: Day 14 ,day 28 ,month 6 after vaccination
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14, day 28, month 6 after booster vaccination in cohort 1.
Measured: Day 14 ,day 28 ,month 6 after vaccination
Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain at day 14, day 28, month 6 after booster vaccination in cohort 1.
Measured: Day 14 ,day 28 ,month 6 after vaccination
GMT of binding antibody against SARS-CoV-2 S protein
GMT of binding antibody against SARS-CoV-2 S protein at day 14, day 28, month 6 after booster vaccination in cohort 1.
Measured: Day 14 ,day 28 ,month 6 after vaccination
Geometric mean fold rise(GMFR) of binding antibody against SARS-CoV-2 S protein
Geometric mean fold rise(GMFR) of binding antibody against SARS-CoV-2 S protein at day 14, day 28, month 6 after booster vaccination in cohort 1.
Measured: Day 14 ,day 28 ,month 6 after vaccination
Seroconversion rate of binding antibody against SARS-CoV-2 S protein
Seroconversion rate of binding antibody against SARS-CoV-2 S protein at day 14, day 28, month 6 after booster vaccination in cohort 1.
Measured: Day 14 ,day 28 ,month 6 after vaccination
The occurrence of adverse events
The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccinatio
Measured: 30 mins,7 days and 28 days after vaccination
The occurrence rate of serious adverse events (SAEs) and adverse events of special interest (AESIs)
The occurrence rate of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after vaccination（28 days after vaccination for positive control group）
Measured: Day 0 to 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 posted27 Dec 2022
- Study start28 Dec 2022
- Primary completion18 Jan 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (actual)
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
- Xianfeng Zhang, Principal investigator, Hubei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664932
- Sponsor's protocol ID
- LYB001/CT-CHN-301
- Status last verified
- Dec 2022
- First submitted
- 23 Dec 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang BF, Jin J, He XR, Yang ZH, Qian X, Tong YQ, Ke CX, Li ZH, Li ZX, Zhong LF, Gan ZH, Zhang XF, Zeng Y. Immunogenicity and safety of SARS-CoV-2 recombinant protein vaccine (CHO cell) LYB001 as a heterologous booster following two- or three-dose inactivated COVID-19 vaccine in adults aged >/=18 years: interim results of a randomized, active-controlled, double-blinded, phase 3 trial. Expert Rev Vaccines. 2025 Dec;24(1):81-90. doi: 10.1080/14760584.2024.2446288. Epub 2025 Jan 5.
PubMed 39720838
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Immunogenicity and Safety of a Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Above Who Have Completed Two-dose or Three-dose Inactivated COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05664932
- Acronym / sponsor ID
- LYB001/CT-CHN-301
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Yantai Patronus Biotech Co., Ltd.
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Dec 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.
A total of 1200 people aged 18 years and older who have completed two or three-dose inactivated COVID-19 vaccine for 6-18 months will be recruited in this study. Subjects will be received 1 dose at day 0 as a booster vaccination.Immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 will be evaluated.
Detailed description
The study is a randomized, double-blind, positive control design and 1200 subjects are randomly assigned to LYB001 and positive control groups in a 1:1 ratio to evaluate the safety and immunogenicity as a booster vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LYB001 Booster Group | Experimental | Biological: Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001Subjects 18 years of age or older who has completed two or three-dose inactivated COVID-19 will receive 30μg LYB001 at day 0 as a booster vaccination. |
| ZF2001 Booster Group | Active comparator | Biological: ZF2001Subjects 18 years of age or older who has completed two or three-dose inactivated COVID-19 will receive ZF2001 at day 0 as a booster vaccination. |
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 for 6-18 months .
- 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 two- or three-dose inactivated COVID-19 vaccination;
- Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg 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 close contact with a confirmed/suspected COVID-19 patient or positive results for SARS-CoV-2 nucleic acid ;
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 |
|---|---|---|
| Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001Intramuscular injection of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL. | Biological | LYB001 Booster Group |
| ZF2001Intramuscular injection of ZF2001 in the deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL. | Biological | ZF2001 Booster Group |
Primary outcome
Geometric neutralizing titers (GMT) of neutralizing antibody against variants of concern(VOCs)
Time frame: Day 14 after booster vaccination
Geometric neutralizing titers (GMT) of neutralizing antibody against variants of concern(VOCs) at day 14 after booster vaccination in cohort 1.
8 secondary outcomes
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)
Time frame: Day 14 ,day 28 ,month 6 after vaccination
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
Time frame: Day 14 ,day 28 ,month 6 after vaccination
Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Time frame: Day 14 ,day 28 ,month 6 after vaccination
GMT of binding antibody against SARS-CoV-2 S protein
Time frame: Day 14 ,day 28 ,month 6 after vaccination
Geometric mean fold rise(GMFR) of binding antibody against SARS-CoV-2 S protein
Time frame: Day 14 ,day 28 ,month 6 after vaccination
Seroconversion rate of binding antibody against SARS-CoV-2 S protein
Time frame: Day 14 ,day 28 ,month 6 after vaccination
The occurrence of adverse events
Time frame: 30 mins,7 days and 28 days after vaccination
The occurrence rate of serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: Day 0 to 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 26 Sep 2023.
- Derived from this study: PubMed 39720838Yang BF, Jin J, He XR, Yang ZH, Qian X, Tong YQ, Ke CX, Li ZH, Li ZX, Zhong LF, Gan ZH, Zhang XF, Zeng Y. Immunogenicity and safety of SARS-CoV-2 recombinant protein vaccine (CHO cell) LYB001 as a heterologous booster following two- or three-dose inactivated COVID-19 vaccine in adults aged >/=18 years: interim results of a randomized, active-controlled, double-blinded, phase 3 trial. Expert Rev Vaccines. 2025 Dec;24(1):81-90. doi: 10.1080/14760584.2024.2446288. Epub 2025 Jan 5.
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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.
Xianfeng Zhang principal investigator
Hubei Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 and ZF2001 in people with COVID-19, 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 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 26 Sep 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. 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 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?
Geometric neutralizing titers (GMT) of neutralizing antibody against variants of concern(VOCs) (time frame: Day 14 after booster vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05664932, which also lists 1 linked publication.
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 Sep 2023.