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COVID-19Phase 1NCT05552573

Safety and Immunogenicity of COVID-19 Vaccine in Population Aged 18 Years and Above

A Phase 1 study testing low-dose LYB001, Recombinant COVID-19 Vaccine (CHO Cell) and high-dose LYB001 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a randomized, blinded, positive-controlled study to evaluate the safety and immnunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above. 100 subjects will be recruited in this study, including 50 aged 18-59 years old and 50 aged 60 years old and above. 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?
low-dose LYB001, Recombinant COVID-19 Vaccine (CHO Cell) and high-dose LYB001
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
19 Jul 2022to 1 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18 years and above.
  • Participate the trial voluntarily and sign informed consent form.
  • Subjects are willing to comply with the requirements of the clinical trial protocol -and complete the study follow-up.
  • Armpit temperature ≤37.0℃ on the day of enrollment.
  • Novel Coronavirus (COVID-19) Antibody (IgG and IgM) was negative.

Who cannot join

  • Known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines
  • History of severe acute respiratory syndrome (SARS) and/or Middle East respiratory syndrome (MERS) infection or disease;
  • History of COVID-19, or close contact with a confirmed/suspected COVID-19 patient, or SARS-CoV-2 nucleic acid test was positive or antibody test (IgG, IgM) was positive;
  • Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment;
  • Has received COVID-19 vaccine;
  • vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment;
Show all 20Show fewer
  • Administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use during the trial;
  • Patients with the following diseases:
  • Any acute disease or in the acute phase of chronic diseases within 7 days before enrollment;
  • Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.;
  • History of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids;
  • Known diagnosis of or having infectious diseases, or positive for any one of HBsAg, anti-HCV antibody, anti-TP antibody or anti-HCV antibody;
  • Neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history;
  • Asplenia or functional asplenia;
  • Serious or uncontrollable cardiovascular diseases, diabetes, hematological and lymphatic diseases, immune system diseases, liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization;
  • Contraindications of intramuscular injection and blood drawing, such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant;
  • Severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) History of major surgery within 12 weeks before enrollment (in the opinion of the investigator), or incomplete recovery after surgery, or planning major surgery during the trial;
  • Participating or will participate other clinical trials during this trial;
  • Any disease or condition that, in the opinion of the investigator, would pose an unacceptable risk to the subject; the subject is unable to meet the protocol requirement; will interfere with evaluation of investigational vaccine.
  • Women who were breastfeeding or pregnant during the clinical study or planned to become pregnant during the study;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Provincial Center for Disease Control and Prevention

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: A Randomized, Blinded, Positive-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Population Aged 18 Years and Above

This is a randomized, blinded, positive-controlled study to evaluate the safety and immnunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above. 100 subjects will be recruited in this study, including 50 aged 18-59 years old and 50 aged 60 years old and above.

Read the detailed description

All subjects will be received 3 doses of LYB001, according to the immunization schedule of 0, 28, 56 days. The adverse events within 28 days after vaccination will be observed. In addition, blood samples will be collected on day 0 before vaccination,day 14 after dose 2, and on day 14, 28 and month 3, 6, 9, 12 after full vaccination. Serum antibody levels, cellular immune responses will be analyzed to evaluate the immunogenicity and immune persistence of the vaccine.

Conditions
COVID-19
Being tested
low-dose LYB001, Recombinant COVID-19 Vaccine (CHO Cell), high-dose LYB001
Medical subject headings
COVID-19

What participants receive

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

  • low-dose LYB001Biological

    This vaccine is prepared through gene recombination and 3 doses of low-dose(30µg/0.5ml) LYB001 at the schedule of 0, 28, 56 days.

  • Recombinant COVID-19 Vaccine (CHO Cell)Biological

    This vaccine is Positive-controlled vaccine and 3 doses (0.5ml) at the schedule of 0, 28, 56 days.

  • high-dose LYB001Biological

    This vaccine is prepared through gene recombination and 3 doses of high-dose(60µg/0.5ml) LYB001 at the schedule of 0, 28, 56 days.

Study groups in NCT05552573
Study groupRoleWhat they receive
Low-dose vaccine(18-59 years)Experimental3 doses of LYB001 or Recombinant COVID-19 Vaccine (CHO Cell) at the immunization schedule of 0, 28, 56 days. Vaccination or positve-controlled group will be randomly assigned to receive in a 4:1 ratio.
Receives: Biological: low-dose LYB001; Biological: Recombinant COVID-19 Vaccine (CHO Cell)
Low-dose vaccine(60 years old and above)Experimental3 doses of LYB001 or Recombinant COVID-19 Vaccine (CHO Cell) at the immunization schedule of 0, 28, 56 days. Vaccination or positve-controlled group will be randomly assigned to receive in a 4:1 ratio.
Receives: Biological: low-dose LYB001; Biological: Recombinant COVID-19 Vaccine (CHO Cell)
High-dose vaccine(18-59 years)Experimental3 doses of LYB001 or Recombinant COVID-19 Vaccine (CHO Cell) at the immunization schedule of 0, 28, 56 days. Vaccination or positve-controlled group will be randomly assigned to receive in a 4:1 ratio.
Receives: Biological: Recombinant COVID-19 Vaccine (CHO Cell); Biological: high-dose LYB001
High-dose vaccine(60 years old and above)Experimental3 doses of LYB001 or Recombinant COVID-19 Vaccine (CHO Cell) at the immunization schedule of 0, 28, 56 days. Vaccination or positve-controlled group will be randomly assigned to receive in a 4:1 ratio.
Receives: Biological: Recombinant COVID-19 Vaccine (CHO Cell); Biological: high-dose LYB001

What is being measured

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

  1. The incidence of adverse reactions (ARs)

    The incidence of adverse reactions (ARs) within 7 days after each vaccination

    Measured: Day 0-7 days after each vaccination

Secondary outcomes (10)

  1. The occurrence of adverse events

    The occurrence of adverse events within 28 days after vaccination

    Measured: Day 0-28 days after each vaccination

  2. The incidences of serious adverse events (SAEs) and adverse events of special interest (AESIs)

    The incidences of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after dose1, dose2 and dose 3.

    Measured: Day 0 to 12 months after dose1, dose2 and dose 3.

  3. Laboratory safety measures: coagulation, blood biochemistry, complete blood count and urinalysis

    The change of laboratory safety measures on day 3 after each vaccination in comparison with that before vaccination.

    Measured: Day 3 after each vaccination.

  4. Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).

    GMT of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14 after the second dose, day 14 ,day 28 , month 3, month 6, month 12 after full vaccination.

    Measured: Day 14 after the second dose, day 14 , day 28 ,month 3, month 6, month 12 after full vaccination.

  5. Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).

    GMFR of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.

    Measured: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.

  6. 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 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.

    Measured: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.

  7. GMT of binding antibody against S protein of SARS-CoV-2 wild strain.

    GMT of binding antibody against S protein of SARS-CoV-2 wild strain at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.

    Measured: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.

  8. GMFR of binding antibody against S protein of SARS-CoV-2 wild strain.

    GMFR of binding antibody against S protein of SARS-CoV-2 wild strain at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.

    Measured: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.

  9. Seroconversion rate of of binding antibody against S protein of SARS-CoV-2 wild strain.

    Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination.

    Measured: Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.

  10. The cytokine levels (Elispot): Th1 type: IL-2, IFN-γ; Th2 type: IL-4.

    The cytokine levels (Elispot) at day 14 after the second dose, day 14 after full vaccination.

    Measured: Day 14 after the second dose, day 14 after full vaccination.

Timeline

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

  1. First posted23 Sep 2022
  2. Study start19 Jul 2022
  3. Primary completion10 Jan 2023
  4. Study completion1 Dec 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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552573
Sponsor's protocol ID
LYB001/CT-CHN-101
Status last verified
Sep 2022
First submitted
15 Sep 2022
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tang R, Zeng Y, Zhou Y, Liang Q, Kang W, Yang Z, Zheng X, Zang X, Pan H, Jin J, Zhu F. Safety and immunogenicity of the SARS-CoV-2 LYB001 RBD-based VLP vaccine (CHO cell) phase 1 in Chinese adults: a randomized, double-blind, positive-parallel-controlled study. Expert Rev Vaccines. 2024 Jan-Dec;23(1):498-509. doi: 10.1080/14760584.2024.2337051. Epub 2024 May 2.

    PubMed 38695310

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing low-dose LYB001, Recombinant COVID-19 Vaccine (CHO Cell) and high-dose LYB001 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 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 10 Mar 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

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 incidence of adverse reactions (ARs) (time frame: Day 0-7 days after each 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 NCT05552573, 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 10 Mar 2023.

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