Safety and Immunogenicity of Recombinant COVID-19 Trivalent Protein Vaccine （CHO Cell）LYB002V14 in Booster Vaccination
NCT ID: NCT06167915
Last Updated: 2023-12-26
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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NOT_YET_RECRUITING
PHASE1
120 participants
INTERVENTIONAL
2023-12-26
2024-12-31
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 group
30μg dose of LYB002V14 vaccine IM, on day 0.
30μg dose of LYB002V14
30μg dose of LYB002V14 vaccine IM, on day 0
High dose vaccine group
60μg dose of LYB002V14 vaccine IM, on day 0.
60μg dose of LYB002V14
60μg dose of LYB002V14 vaccine IM, on day 0
Placebo group
placebo IM, on day 0.
placebo
placebo IM, on day 0
Interventions
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30μg dose of LYB002V14
30μg dose of LYB002V14 vaccine IM, on day 0
60μg dose of LYB002V14
60μg dose of LYB002V14 vaccine IM, on day 0
placebo
placebo IM, on day 0
Eligibility Criteria
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Inclusion Criteria
2. Participate voluntarily and sign an informed consent form and have the ability to understand research procedures.
3. Negative SARS-CoV-2 nucleic acid test and SARS-CoV-2 IgM test.
4. Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment.
5. Without a history of SARS-CoV-2 infection or known SARS-CoV-2 infection more than 3 months prior to screening.
6. Fertile women take effective contraceptive measures 1 month before enrollment; Fertile women (except those received hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy) and men of childbearing potential voluntarily agree to take effective contraceptive measures from screening to 3 months after vaccination and without a plan of pregnancy and germ cell donation.
Exclusion Criteria
2. Have a known history of SARS and MERS.
3. Administration of antipyretics, painkillers or anti-allergy drugs within 24 hours prior to enrolment.
4. Receipt of subunit and/or inactivated vaccine within 7 days prior to vaccination or receipt of any live attenuated vaccine within 14 days prior to vaccination.
5. History of SARS-CoV-2 vaccination within 3 months prior to enrollment; Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study.
6. Participants with the following diseases: ①Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment. ②Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. ③Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (\>14 immunosuppressive agents within the past 6 months with exception of inhaled or topical steroids, or short-term use （≤14 consecutive days） of oral corticosteroids. ④Currently suffering from or diagnosed with infectious diseases, or positive screening results for human immunodeficiency virus antibody. ⑤History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders. ⑥Asplenia, or functional asplenia. ⑦Presence 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. ⑧Contraindications to IM injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage. ⑨Hypertension not controlled by medication (on-site measurement: systolic blood pressure ≥ 160mmHg and / or diastolic blood pressure ≥ 100mmHg).
7. Have a history of major surgery within 3 months before enrollment （based on the judgment of the researchers）, or has not yet fully recovered from the surgery, or has a major surgical plan during the study.
8. Those participating or planning to participate in other clinical trials during the study period.
9. Those unsuitable for participating in the clinical trial as determined by the investigator because of other abnormalities that are likely to confuse or confound the study results, or non-conformance with the maximal benefits of the participants.
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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Qin Yu, Master
Role: PRINCIPAL_INVESTIGATOR
West China Second University Hospital
Locations
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West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Qin Yu, Master
Role: primary
Other Identifiers
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LYB002V14/CT-CHN-101
Identifier Type: -
Identifier Source: org_study_id