COVID-19Phase 2NCT05663086

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

A Phase 2 study testing One dose group, Two doses group and Aged 18-59 years in people with COVID-19, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: One dose group, Two doses group and Aged 18-59 years
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteChina
Study dates: 7 Jan 2023to 27 Jun 2023
Phase: Phase 2
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

People aged 18 years and above who have not received COVID-19 vaccine or whose last vaccination was at least 6 months ago (at the time of screening).
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.
2019 Novel Coronavirus (COVID-19) Antibody 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) or COVID-19 infection or disease;
Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment;
vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment;
Administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use duringthe trial;
Patients with the following diseases:

Show all 19Show fewer

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;
Positive for anti-AIDS 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 (judged by 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 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 II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Population Aged 18 Years and Above（Negative for Antibody Against COVID-19）

This is a randomized, blinded, positive-controlled study to evaluate the immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above（negative antibody against COVID-19）. 720 subjects will be recruited in this study, including 360 in 1 dose of 30 or 60 μg group and 360 in 2 doses of 30 or 60 μg group. The age group consists of 18-59 years old and 60 years old and above.

Read the detailed description

Subjects will receive 1 dose or 2 doses of LYB001, according to the immunization schedule of 0 day or 0, 28 days. The adverse events within 28 days after each vaccination will be observed. In addition, blood samples will be collected on day 0 before vaccination,and on day 7, 14, 28 and month 3, 6, 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: One dose group, Two doses group, Aged 18-59 years, Aged 60 years old and above
Medical subject headings: COVID-19

What participants receive

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

One dose groupBiological
The vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
Two doses groupBiological
The vaccines are to be administrated at day 0 and 28. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
Aged 18-59 yearsBiological
The vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.
Aged 60 years old and aboveBiological
The vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

Study groups in NCT05663086
Study group	Role	What they receive
Low-dose vaccine	Experimental	30μg LYB001 is to be used in the clinical trial. The number of each arm is 60. Receives: Biological: One dose group; Biological: Two doses group; Biological: Aged 18-59 years; Biological: Aged 60 years old and above
High-dose vaccine	Experimental	60μg LYB001 is to be used in the clinical trial. The number of each arm is 60. Receives: Biological: One dose group; Biological: Two doses group; Biological: Aged 18-59 years; Biological: Aged 60 years old and above
Positive control	Active comparator	Positive-controlled vaccine is to be used in the clinical trial. The number of each arm is 60. Receives: Biological: One dose group; Biological: Two doses group; Biological: Aged 18-59 years; Biological: Aged 60 years old and above

What is being measured

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

Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 14 after full vaccination.
Measured: Day 14 after full vaccination.

Secondary outcomes (9)

The occurrence of adverse events
The occurrence of adverse events within 30 mins,7 days and 28 days after each vaccination
Measured: 30 mins,7 days and 28 days after each vaccination
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after dose1 and dose2
Measured: Day 0 to 12 months after dose1and dose2
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 7, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
Measured: Day 7 , day 28 ,month 3, month 6, month 12 after full vaccination
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 7, day14, day 28 , month 3, month 6, month 12 after full vaccination and the difference between immunization schedule
Measured: Day 7, day 14, day 28 , month 3, month 6, month 12 after full 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 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Measured: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs).
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs) at day 7, day 14 ,day 28, month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Measured: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
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 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Measured: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain.
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain at day 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Measured: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Seroconversion rate 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 7,day 14 ,day 28,month 3, month 6, month 12 after full vaccination and the difference between immunization schedule.
Measured: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination

Timeline

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

7 Jan 202327 Jun 2023

First posted23 Dec 2022
Study start7 Jan 2023
Primary completion27 Jun 2023
Study completion27 Jun 2023

Why it stopped: According to the development of the novel coronavirus epidemic situation and the company's R\&D decision

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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05663086
Sponsor's protocol ID: LYB001/CT-CHN-202
Status last verified: Dec 2022
First submitted: 22 Dec 2022
Last updated: 26 Sep 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Blinded, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in Population Aged 18 Years and Above（Negative for Antibody Against COVID-19）
ClinicalTrials.gov ID: NCT05663086
Acronym / sponsor ID: LYB001/CT-CHN-202
Conditions: COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: According to the development of the novel coronavirus epidemic situation and the company's R\&D decision
Enrolment: 0 participants (actual)
Lead sponsor: Guangzhou Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Yantai Patronus Biotech Co., Ltd.
Study start: 7 Jan 2023 (actual)
Primary completion: 27 Jun 2023 (actual)
Study completion: 27 Jun 2023 (actual)
First posted: 23 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Low-dose vaccine	Experimental	Biological: One dose group, Biological: Two doses group, Biological: Aged 18-59 years, Biological: Aged 60 years old and above30μg LYB001 is to be used in the clinical trial. The number of each arm is 60.
High-dose vaccine	Experimental	Biological: One dose group, Biological: Two doses group, Biological: Aged 18-59 years, Biological: Aged 60 years old and above60μg LYB001 is to be used in the clinical trial. The number of each arm is 60.
Positive control	Active comparator	Biological: One dose group, Biological: Two doses group, Biological: Aged 18-59 years, Biological: Aged 60 years old and abovePositive-controlled vaccine is to be used in the clinical trial. The number of each arm is 60.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

People aged 18 years and above who have not received COVID-19 vaccine or whose last vaccination was at least 6 months ago (at the time of screening).
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.
2019 Novel Coronavirus (COVID-19) Antibody was negative.

Key exclusion criteria (19 listed)

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) or COVID-19 infection or disease;
Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment;
vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment;
Administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use duringthe trial;

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
One dose groupThe vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.	Biological	High-dose vaccine, Low-dose vaccine, Positive control
Two doses groupThe vaccines are to be administrated at day 0 and 28. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.	Biological	High-dose vaccine, Low-dose vaccine, Positive control
Aged 18-59 yearsThe vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.	Biological	High-dose vaccine, Low-dose vaccine, Positive control
Aged 60 years old and aboveThe vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.	Biological	High-dose vaccine, Low-dose vaccine, Positive control

Primary outcome

Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Time frame: Day 14 after full vaccination.
GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 14 after full vaccination.

9 secondary outcomes

The occurrence of adverse events
Time frame: 30 mins,7 days and 28 days after each vaccination
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: Day 0 to 12 months after dose1and dose2
Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain
Time frame: Day 7 , day 28 ,month 3, month 6, month 12 after full vaccination
Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs)
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Geometric mean titers (GMT) of neutralizing antibody against variants of concern(VOCs).
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
GMT of binding antibody against S protein of SARS-CoV-2 wild strain.
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Geometric mean fold rise(GMFR) of binding antibody against S protein of SARS-CoV-2 wild strain.
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination
Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain.
Time frame: Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 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.

Fengcai Zhu principal investigator

Jiangsu Province Centers 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 2 study testing One dose group, Two doses group and Aged 18-59 years 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 19 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: withdrawn, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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 mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain (time frame: Day 14 after full 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 NCT05663086.

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.