COVID-19Early Phase 1NCT05928468

The Safety and Immunogenicity Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine LYB002

A Early Phase 1 study testing LYB002V14, LYB002V14A and LYB002CA in people with COVID-19, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To evaluate the safety, humoral immunogenicity, cellular immunogenicity and immune persistence following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine; Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: LYB002V14, LYB002V14A and LYB002CA
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 1 siteChina
Study dates: 25 Apr 2023to 30 Nov 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 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy subjects aged 18-59 years, 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 completed three-dose inactivated COVID-19 vaccine at 6 months earlier;
S-protein binding antibody IgG concentration was less than 300BAU/mL before booster vaccination in cohort 1, while S-protein binding antibody IgG concentration was not screened in cohort 2; Subjects in cohort 1 and cohort 2 were negative in nucleic acid test or antigen test before booster vaccination.
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, or previous vaccination history other than other than three doses of inactivated vaccination;
Abnormal vital signs with clinical significance prior to enrolment, systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg for subjects aged ≥60 years), or axillary body temperature ≥37.3℃;
The results of laboratory tests before enrollment were abnormal and clinically significant as judged by clinicians;
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);
Administration of antipyretics, painkillers or anti-allergy drugs within 24 hours prior to enrolment;

Show all 21Show fewer

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;
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 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 hospitalized cardiovascular diseases, diabetes, 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

Affiliated Hospital of North Sichuan MedicalCollege
Chengdu, Sichuan, 610055

Other trials in China

About this study

Official title: To Evaluate the Safety and Immunogenicity Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Trivalent Vaccine (CHO Cell) LYB002 in Chinese Adults 18 Years and Above Completed Three-dose Inactivated COVID-19 Vaccine

Read the detailed description

Main Objective

To evaluate the safety following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine;
To evaluate the humoral immunogenicity following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine;

Secondary Objectives To evaluate the immune persistence following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine;

For exploratory purposes To evaluate the cellular immunogenicity following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine.

Conditions: COVID-19
Being tested: LYB002V14, LYB002V14A, LYB002CA
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LYB002V14Biological
Participants receiving one or two boost doses of LYB002V14 after a three-dose primary series of inactivated COVID-19 vaccine.
LYB002V14ABiological
Participants receiving one or two boost doses of LYB002V14A after a three-dose primary series of inactivated COVID-19 vaccine.
LYB002CABiological
Participants at 18-59 years old receiving two boost doses of LYB002CA after a three-dose primary series of inactivated COVID-19 vaccine.

Study groups in NCT05928468
Study group	Role	What they receive
LYB002V14	Experimental	The vaccine LYB002V14 was administered through intramuscular injection. Receives: Biological: LYB002V14
LYB002V14A	Active comparator	The vaccine LYB002V14A was administered through intramuscular injection. Receives: Biological: LYB002V14A
LYB002CA	Active comparator	The vaccine LYB002CA was administered through intramuscular injection. Receives: Biological: LYB002CA

What is being measured

The primary outcome is the main question the study is designed to answer.

The frequencies and percentages of adverse events within 30 minutes of each booster dose
Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest will be used to compare the differences between the groups.
Solicited and unsolicited AEs within 30 mins after vaccination will be collected
Measured: within 30 minutes after booster vaccination
The frequencies and percentages of adverse events within 7 days of each booster dose
Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest will be used to compare the differences between the groups.
Solicited local/systemic AEs within 7 days of booster dose will be collected
Measured: 7 days after booster vaccination
The frequencies and percentages of adverse events within 28 days of each booster dose
Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest will be used to compare the differences between the groups.
Unsolicited AEs within 28 days of booster dose will be collected
Measured: 28 days after booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-bindingantibodies at 14 days after each booster immunization
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies(Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicularstomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-bindingantibodies using ELISA assays, at 14 days after each booster immunization will be calculated for each group, compared with the baseline.
Measured: 14 days after each booster vaccination
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-bindingantibodies at 28 days after each booster immunization
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies(Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicularstomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-bindingantibodies using ELISA assays, at 28 days after each booster immunization will be calculated for each group, compared with the baseline.
Measured: 28 days after each booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and Sprotein-binding antibodies at 14 days after each booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs ofneutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCsusing Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, Sprotein-binding antibodies using ELISA assays, at baseline, at 14 days after the booster immunization will be calculated for each group, compared with the baseline.
Measured: 14 days after each booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and Sprotein-binding antibodies at 28 days after each booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs ofneutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCsusing Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, Sprotein-binding antibodies using ELISA assays, at baseline, at 28 days after the booster immunization will be calculated for each group, compared with the baseline.
Measured: 28 days after each booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizingantibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs usingVesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at baseline, at 14 days after the booster immunization will be calculated for each group, compared with the baseline.
Measured: 14 days after each booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after the booster immunization
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizingantibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs usingVesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at baseline, at 28 days after the booster immunization will be calculated for each group, compared with the baseline.
Measured: 28 days after each booster vaccination

Secondary outcomes (5)

The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies(Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicularstomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-bindingantibodies using ELISA assays, at 3 months after the last booster immunization will be calculated for all participants.
Measured: 3 months after the last booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and GMC of Sprotein-binding antibodies
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs ofneutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCsusing Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, the GMC of Sprotein-binding antibodies using ELISA assays, at 3 months after the last booster immunization will be calculated for all participants.
Measured: 3 months after the last booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizingantibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs usingVesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 3 months after the last booster immunization will be calculated for all participants.
Measured: 3 months after the last booster vaccination
The frequencies and percentages of adverse events
The incidence of serious adverse events (SAE) and adverse events of special interest (AESI) in all participants within 6 months after the last booster dose;
Measured: 6 months after the last booster vaccination
The changes of the frequencies and percentages of adverse events from the baseline at the 3rd day after each boost vaccination
the changes of laboratory tests on the third day after each dose of booster vaccination compared with those before vaccination
Measured: 3 days after each booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 202330 Nov 2023

First posted3 Jul 2023
Study start25 Apr 2023
Primary completion31 Jul 2023 (estimated)
Study completion30 Nov 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: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 210 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05928468
Sponsor's protocol ID: LYB002/CT-CHN-IIT02
Status last verified: Jun 2023
First submitted: 29 Jun 2023
Last updated: 3 Jul 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Evaluate the Safety and Immunogenicity Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Trivalent Vaccine (CHO Cell) LYB002 in Chinese Adults 18 Years and Above Completed Three-dose Inactivated COVID-19 Vaccine
ClinicalTrials.gov ID: NCT05928468
Acronym / sponsor ID: LYB002/CT-CHN-IIT02
Conditions: COVID-19
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 210 participants (estimated)
Lead sponsor: Guangzhou Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Yantai Patronus Biotech Co., Ltd., Afﬁliated Hospital of North Sichuan Medical College
Study start: 25 Apr 2023 (actual)
Primary completion: 31 Jul 2023 (estimated)
Study completion: 30 Nov 2023 (estimated)
First posted: 3 Jul 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.

Detailed description

Main Objective

To evaluate the safety following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine;
To evaluate the humoral immunogenicity following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine;

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
LYB002V14	Experimental	Biological: LYB002V14The vaccine LYB002V14 was administered through intramuscular injection.
LYB002V14A	Active comparator	Biological: LYB002V14AThe vaccine LYB002V14A was administered through intramuscular injection.
LYB002CA	Active comparator	Biological: LYB002CAThe vaccine LYB002CA was administered through intramuscular injection.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Healthy subjects aged 18-59 years, 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 completed three-dose inactivated COVID-19 vaccine at 6 months earlier;
S-protein binding antibody IgG concentration was less than 300BAU/mL before booster vaccination in cohort 1, while S-protein binding antibody IgG concentration was not screened in cohort 2; Subjects in cohort 1 and cohort 2 were negative in nucleic acid test or antigen test before booster vaccination.
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 (21 listed)

Receipt of any COVID-19 prophylactic medication, or previous vaccination history other than other than three doses of inactivated vaccination;
Abnormal vital signs with clinical significance prior to enrolment, systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg for subjects aged ≥60 years), or axillary body temperature ≥37.3℃;
The results of laboratory tests before enrollment were abnormal and clinically significant as judged by clinicians;
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);

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
LYB002V14Participants receiving one or two boost doses of LYB002V14 after a three-dose primary series of inactivated COVID-19 vaccine.	Biological	LYB002V14
LYB002V14AParticipants receiving one or two boost doses of LYB002V14A after a three-dose primary series of inactivated COVID-19 vaccine.	Biological	LYB002V14A
LYB002CAParticipants at 18-59 years old receiving two boost doses of LYB002CA after a three-dose primary series of inactivated COVID-19 vaccine.	Biological	LYB002CA

Primary outcome

The frequencies and percentages of adverse events within 30 minutes of each booster dose
Time frame: within 30 minutes after booster vaccination
Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest will be used to compare the differences between the groups. Solicited and unsolicited AEs within 30 mins after vaccination will be collected
The frequencies and percentages of adverse events within 7 days of each booster dose
Time frame: 7 days after booster vaccination
Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest will be used to compare the differences between the groups. Solicited local/systemic AEs within 7 days of booster dose will be collected
The frequencies and percentages of adverse events within 28 days of each booster dose
Time frame: 28 days after booster vaccination
Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest will be used to compare the differences between the groups. Unsolicited AEs within 28 days of booster dose will be collected
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-bindingantibodies at 14 days after each booster immunization
Time frame: 14 days after each booster vaccination
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies(Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicularstomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-bindingantibodies using ELISA assays, at 14 days after each booster immunization will be calculated for each group, compared with the baseline.
The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-bindingantibodies at 28 days after each booster immunization
Time frame: 28 days after each booster vaccination
The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies(Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicularstomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-bindingantibodies using ELISA assays, at 28 days after each booster immunization will be calculated for each group, compared with the baseline.
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and Sprotein-binding antibodies at 14 days after each booster vaccination
Time frame: 14 days after each booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs ofneutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCsusing Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, Sprotein-binding antibodies using ELISA assays, at baseline, at 14 days after the booster immunization will be calculated for each group, compared with the baseline.
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and Sprotein-binding antibodies at 28 days after each booster vaccination
Time frame: 28 days after each booster vaccination
The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs ofneutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCsusing Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, Sprotein-binding antibodies using ELISA assays, at baseline, at 28 days after the booster immunization will be calculated for each group, compared with the baseline.
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization
Time frame: 14 days after each booster vaccination
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizingantibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs usingVesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at baseline, at 14 days after the booster immunization will be calculated for each group, compared with the baseline.
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after the booster immunization
Time frame: 28 days after each booster vaccination
The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizingantibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs usingVesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at baseline, at 28 days after the booster immunization will be calculated for each group, compared with the baseline.

5 secondary outcomes

The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding
Time frame: 3 months after the last booster vaccination
The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and GMC of Sprotein-binding antibodies
Time frame: 3 months after the last booster vaccination
The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies
Time frame: 3 months after the last booster vaccination
The frequencies and percentages of adverse events
Time frame: 6 months after the last booster vaccination
The changes of the frequencies and percentages of adverse events from the baseline at the 3rd day after each boost vaccination
Time frame: 3 days after each booster vaccination

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.

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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.

Xiaolan Yong, Bachelor principal investigator

Affiliated Hospital to North Sichuan MedicalCollege

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 LYB002V14, LYB002V14A and LYB002CA 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 5 inclusion and 21 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 3 Jul 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?

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?

The frequencies and percentages of adverse events within 30 minutes of each booster dose (time frame: within 30 minutes after booster vaccination). The study lists 9 primary outcomes in all. 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 NCT05928468.

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 3 Jul 2023.