Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19
Study Details
Study Description
Brief Summary
This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This study a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine .The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.A total of 1200 subjects who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month will be enrolled.All of subjects will be randomly divided into two groups in a 1:1 ratio .Subjects in experimental group will receive high-dosage SARS-CoV-2 inactivated vaccine.Subjects in control group will receive medium-dosage SARS-CoV-2 inactivated vaccine .
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Group 600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine . |
Biological: High-dosage SARS-CoV-2 vaccine
SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
| Active Comparator: Control Group 600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine . |
Biological: Medium-dosage SARS-CoV-2 vaccine
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain） [Day 28 after booster vaccination]
GMT of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination.
Secondary Outcome Measures
- Immunogenicity index-seropositive rate of neutralizing antibodies（CZ02 strain） [Day 28 after booster vaccination]
The seropositive rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination
- Immunogenicity index-seroconversion rate of neutralizing antibodies（CZ02 strain） [Day 28 after booster vaccination]
The seroconversion rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination
- Immunogenicity index-GMI of neutralizing antibodies（CZ02 strain） [Day 28 after booster vaccination]
GMI of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination
- Immunogenicity index-seropositive rate of neutralizing antibodies（Delta Strain） [Day 28 after booster vaccination]
The seropositive rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
- Immunogenicity index-seroconversion rate of neutralizing antibodies（Delta Strain） [Day 28 after booster vaccination]
The seroconversion rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
- Immunogenicity index-GMI of neutralizing antibodies（Delta Strain） [Day 28 after booster vaccination]
GMI of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
- Immunogenicity index-seroconversion rate of neutralizing antibodies（Omicron Strain） [Day 28 after booster vaccination]
The seroconversion rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
- Immunogenicity index-seropositive rate of neutralizing antibodies（Omicron Strain） [Day 28 after booster vaccination]
The seropositive rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
- Immunogenicity index-GMI of neutralizing antibodies（Omicron Strain） [Day 28 after booster vaccination]
GMI of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
- Immunogenicity index-GMT of neutralizing antibodies（Omicron Strain） [Day 28 after booster vaccination]
GMT of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
- Immunogenicity index-GMT of neutralizing antibodies（Delta Strain） [Day 28 after booster vaccination]
GMT of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
Other Outcome Measures
- Immunogenicity index-the seropositive rate of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain） [6 months after the booster vaccination]
The seroconversion rate of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain） 6 months after the booster vaccination
- Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain） [6 months after the booster vaccination]
GMI of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain） 6 months after the booster vaccination
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged 18-59;
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Proven legal identity;
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The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
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Have received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd at an interval of 21 to 35 days and is currently 6-8 months (180 to 240 days) after the second dose.
Exclusion Criteria:
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History of SARS-CoV-2 infection(laboratory confirmed);
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Have received three and more doses of inactivated SARS-CoV-2 vaccine;
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Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
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Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
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Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
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Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
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Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
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History of alcohol or drug abuse;
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Receipt of blood products within in the past 3 months;
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Receipt of other investigational drugs in the past 30 days;
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Receipt of attenuated live vaccines in the past 14 days;
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Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
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Axillary temperature >37.0°C;
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Already pregnant or are breastfeeding, planning to get pregnant within 1months (according to subjects' self-report and urine pregnancy test results);
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Participated in other clinical trials prior to enrollment and during the follow-up period, or planned to participate in other clinical trials during the clinical trial period;
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According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xinqi City Center for Disease Control and Prevention | Xinqi | Jiangsu | China | 221400 |
Sponsors and Collaborators
- Sinovac Biotech Co., Ltd
Investigators
- Principal Investigator: Hongxing Pan, Master, Jiangsu Provincial Center for Disease Prevention and Control
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-nCOV-4007