AzTrials
AzTrials

COVID-19Phase 2/3NCT05137444

Phase Ⅱ and Ⅲ Trial of a SARS-CoV-2 Vaccine LYB001

A Phase 2/3 study testing LYB001 in people with COVID-19, run by Yantai Patronus Biotech Co., Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

The phase Ⅱ trial adopts a randomized, double-blind, placebo-controlled design to evaluate the immunogenicity and safety profile of LYB001 in healthy adults aged 18 years and older. 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
1,900 participants
Where
No sites listed yet
Study dates
Jan 2022to May 2023
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;
  • 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.).

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;
Show all 22Show fewer
  • 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 (Pathogen screening test will be only conducted in phase Ⅱ)；
  • 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.

Jingwen Qu contact

+8615626903973

qujingwen@luye.com

About this study

Official title: Immunogenicity and Safety of a SARS-CoV-2 Vaccine LYB001 in Healthy Adults: a Randomized, Double Blinded, Placebo-controlled Phase Ⅱ Trial and a Single-arm, Open-label Phase Ⅲ Trial for Extended Safety

The phase Ⅱ trial adopts a randomized, double-blind, placebo-controlled design to evaluate the immunogenicity and safety profile of LYB001 in healthy adults aged 18 years and older. This Phase III study adopts a single-arm, open-label design to evaluate the expanded safety of LYB001 in healthy subjects 18 years of age and older. The study vaccine will be administered IM at upper arm deltoid as a three-dose regimen with 28d interval on day 0, 28, 56.

The phase Ⅱ trial will be carried out in an age-sequential enrolment manner:

Read more
  1. A DSMB meeting will be held after the completion of the 7-day safety observation following each vaccination of high-dose LYB001 or placebo in participants aged 18-59 years in phase Ⅰ trial. Thereafter, the DSMB will recommend whether to initiate enrollment of younger adult participants in the Phase II trial based on the findings, who will receive low dose (25μg), high dose (50μg) LYB001 or placebo at a ratio of 3:3:1.
  2. A DSMB meeting will be held after the completion of the 7-day safety observation following each vaccination of high-dose LYB001 or placebo in participants aged ≥60 year in phase Ⅰ trial. Thereafter, the DSMB will recommend whether to initiate enrollment of older adult participants in the Phase II trial based on the findings, who will receive low dose (25μg), high dose (50μg) LYB001 or placebo at a ratio of 3:3:1.
  3. The phase Ⅱ trial will be ended after all participants completed 360-day safety observation following the 3rd dose of vaccination.

Phase III trial (the expanded safety study):

  1. After completion of the 7-day safety observation following the first immunization of all cohorts in the Phase II trial, a DSMB meeting will be held to recommend whether to initiate enrollment of participants in the Phase III trial. A total of 1200 subjects will be enrolled in younger adult and older adults, with older adults accounting for ≥20% of the population, and appropriate doses will be determined based on the results of early clinical trials.
  2. The phase III trial 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.

  • PlaceboBiological

    Aluminum hydroxide

Study groups in NCT05137444
Study groupRoleWhat they receive
low-dose LYB001 in participants aged 18-59 yearsExperimental25μg/0.5ml/Vial. Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56.
Receives: Biological: LYB001
high-dose LYB001 in participants aged 18-59 yearsExperimental50μg/0.5ml/Vial. Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56.
Receives: Biological: LYB001
placebo in participants aged 18-59 yearsPlacebo comparatorintramuscular injection (IM) at upper arm deltoid on day 0, 28, 56.
Receives: Biological: Placebo
low-dose LYB001 in participants aged over 60 yearsExperimental25μg/0.5ml/Vial. Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56.
Receives: Biological: LYB001
high-dose LYB001 in participants aged over 60 yearsExperimental50μg/0.5ml/Vial. Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56.
Receives: Biological: LYB001
placebo in participants aged over 60 yearsPlacebo comparatorintramuscular injection (IM) at upper arm deltoid on day 0, 28, 56.
Receives: Biological: Placebo
LYB001 in participants aged over 18 yearsExperimentalintramuscular injection (IM) at upper arm deltoid on day 0, 28, 56.
Receives: Biological: LYB001

What is being measured

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

  1. Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Measured: Change from Baseline at 14 days post dose 3

  2. SRAS-CoV-2 S protein-binding antibodies

    SRAS-CoV-2 S protein-binding antibodies

    Measured: Change from Baseline at 14 days post dose 3

  3. Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Measured: Change from Baseline at 28 days post dose 3

  4. SRAS-CoV-2 S protein-binding antibodies

    SRAS-CoV-2 S protein-binding antibodies

    Measured: Change from Baseline at 28 days post dose 3

  5. Adverse events (AEs)

    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 (7)

  1. Serious adverse events (SAEs)

    Serious adverse events (SAEs) throughout the study

    Measured: 360 days after first dose

  2. Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Measured: 3 months post dose 3

  3. Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Measured: 6 months post dose 3

  4. Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

    Measured: 12 months post dose 3

  5. SRAS-CoV-2 S protein-binding antibodies

    SRAS-CoV-2 S protein-binding antibodies

    Measured: 3 months post dose 3

  6. SRAS-CoV-2 S protein-binding antibodies

    SRAS-CoV-2 S protein-binding antibodies

    Measured: 6 months post dose 3

  7. SRAS-CoV-2 S protein-binding antibodies

    SRAS-CoV-2 S protein-binding antibodies

    Measured: 12 months post dose 3

Timeline

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

  1. First posted30 Nov 2021
  2. Study startJan 2022 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionMay 2023 (estimated)

Resources

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
1,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05137444
Sponsor's protocol ID
LYB001/CT-LAO-202&302
Status last verified
Nov 2021
First submitted
12 Nov 2021
Last updated
30 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 3 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 30 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 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?

Contact Jingwen Qu (+8615626903973, qujingwen@luye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs) (time frame: Change from Baseline at 14 days post dose 3). The study lists 5 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 NCT05137444.

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 30 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in