Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above
NCT ID: NCT05663086
Last Updated: 2023-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-01-07
2023-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Low-dose vaccine
30μg LYB001 is to be used in the clinical trial. The number of each arm is 60.
One dose group
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 group
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 years
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 above
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.
High-dose vaccine
60μg LYB001 is to be used in the clinical trial. The number of each arm is 60.
One dose group
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 group
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 years
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 above
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.
Positive control
Positive-controlled vaccine is to be used in the clinical trial. The number of each arm is 60.
One dose group
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 group
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 years
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 above
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.
Interventions
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One dose group
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 group
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 years
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 above
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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:
1. Any acute disease or in the acute phase of chronic diseases within 7 days before enrollment;
2. Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.;
3. 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;
4. Positive for anti-AIDS antibody;
5. Neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history;
6. Asplenia or functional asplenia;
7. 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;
8. Contraindications of intramuscular injection and blood drawing,such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant;
9. 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;
18 Years
ALL
Yes
Sponsors
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Yantai Patronus Biotech Co., Ltd.
INDUSTRY
Guangzhou Patronus Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Fengcai Zhu
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Disease Control and Prevention
Locations
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Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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LYB001/CT-CHN-202
Identifier Type: -
Identifier Source: org_study_id
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