Status:
UNKNOWN
Safety and Immunogenicity of Recombinant COVID-19 Trivalent Protein Vaccine （CHO Cell）LYB002V14 in Booster Vaccination
Lead Sponsor:
Guangzhou Patronus Biotech Co., Ltd.
Collaborating Sponsors:
Yantai Patronus Biotech Co., Ltd.
Conditions:
SARS-CoV-2
COVID-19 Vaccine
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a randomized, blinded, and dose escalation phase I trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. Th...
Detailed Description
The study is a randomized, blinded and dose escalation Phase I clinical trial. It will evaluate the safety and immunogenicity of 2 dose levels of recombinant COVID-19 trivalent (XBB.1+BQ.1.1+Prototype...
Eligibility Criteria
Inclusion
- Subjects aged 18 years and above when screening.
- Participate voluntarily and sign an informed consent form and have the ability to understand research procedures.
- Negative SARS-CoV-2 nucleic acid test and SARS-CoV-2 IgM test.
- Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment.
- Without a history of SARS-CoV-2 infection or known SARS-CoV-2 infection more than 3 months prior to screening.
- 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
- Have a known allergy, hypersensitivity, or intolerance to the planned investigational vaccine including any excipients of the vaccine. Have a known anaphylactic shock and other serious adverse events to other vaccine.
- Have a known history of SARS and MERS.
- Administration of antipyretics, painkillers or anti-allergy drugs within 24 hours prior to enrolment.
- 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.
- 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.
- 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).
- 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.
- Those participating or planning to participate in other clinical trials during the study period.
- 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.
- Exclusion criteria for selected populations: those who are pregnant or breast-feeding or women of childbearing potential have a positive pregnancy test prior to vaccination.
Key Trial Info
Start Date :
December 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06167915
Start Date
December 26 2023
End Date
December 31 2024
Last Update
December 26 2023
Active Locations (1)
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1
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China