Status:
UNKNOWN
A Phase 1 Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine
Lead Sponsor:
CNBG-Virogin Biotech (Shanghai) Ltd.
Collaborating Sponsors:
Shulan (Hangzhou) Hospital
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
A randomised, blinded, parallel-controlled phase 1 clinical trial to evaluate the safety and preliminary immunogenicity of a COVID-19 mRNA vaccine in a healthy population aged 18 years and older, and ...
Detailed Description
The phase 1 clinical trial is conducted in a randomised, blinded, parallel-controlled design to assess the safety, immunogenicity and immune persistence. Subjects will be divided into two age groups (...
Eligibility Criteria
Inclusion
- Healthy male or female subjects aged ≥18 years of age;
- Subjects who are in good physical condition as judged by the investigator based on medical history, physical examination and clinical laboratory tests;
- Subjects who have not been previously vaccinated with a Covid-19 vaccine or who have received the last dose (total dose ≤ 3 doses) of a Covid-19 vaccine at least 6 months ago;
- Subjects who have not been previously infected with Covid-19, or whose nucleic acid or antigen test has turned negative for more than 1 month after previous Covid-19 infection;
- Subjects who have used effective contraception since 2 weeks prior to enrolment;
- Subjects or their delegates are able to understand the study procedures, have provide written informed consent, and are able to comply with the requirements of the clinical study protocol.
Exclusion
- Females of childbearing potential who have a positive pregnancy test, are pregnant, breastfeeding, or planning to become pregnant within 12 months; males: whose spouse is planning to become pregnant within 1 year;
- History of epilepsy, convulsions or seizures, psychosis or family history of psychosis;
- Subjects who were using antipyretic, analgesic or anti-allergic drugs within 3 days before enrolment;
- Have a previous history of severe allergy to any medication or vaccination (e.g. acute allergic reaction, urticaria, skin eczema, dyspnoea, angioneurotic oedema, or abdominal pain) or allergy to known components of a Covid-19 vaccine;
- Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
- Have a history of hospital-diagnosed known immunological impairment or hypofunction;
- Subjects who have received immunoenhancement or immunosuppressant therapy (continuous use by oral or infusion for more than 14 days) within 3 months, and whole blood, plasma, or immunoglobulin within 1 month;
- Known or suspected concomitant serious diseases, including: respiratory diseases, acute infections or active chronic diseases, liver and kidney diseases, severe diabetes, malignant tumours, infectious or allergic skin diseases, cardiovascular disease, and HIV infection (with test report);
- Subjects suffering from various acute diseases or in the acute exacerbation of chronic diseases within 3 days before vaccination;
- Subjects with clinically significant abnormalities in blood biochemistry, blood routine, urine routine, coagulation function, thyroid function, and myocarditis-related indicators detected during the screening;
- Received live attenuated vaccine within 1 month before vaccination;
- Received inactivated vaccine within 14 days before vaccination;
- Axillary temperature ≥37.3℃;
- Who have participated in other clinical trials within 3 months prior to the first dose of vaccination or plan to participate in other clinical trials during the study period;
- Other conditions that the investigator deems inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
March 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06113744
Start Date
March 10 2023
End Date
June 1 2024
Last Update
November 8 2023
Active Locations (1)
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1
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, China