A Randomized, Double-Blinded Clinical Trial to Evaluate Additional Dose of Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine in Healthy Individuals Previously Vaccinated With CoronaVac
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Sinovac Biotech Co., Ltd
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）
- Last Updated
- 4 years ago
Overview
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.
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 .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults aged 18-59;
- •Proven legal identity;
- •The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
- •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
- •History of SARS-CoV-2 infection(laboratory confirmed);
- •Have received three and more doses of inactivated SARS-CoV-2 vaccine;
- •Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
- •Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
- •Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
- •Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- •Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- •Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- •History of alcohol or drug abuse;
- •Receipt of blood products within in the past 3 months;
Outcomes
Primary Outcomes
Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）
Time Frame: Day 28 after booster vaccination
GMT of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination.
Secondary Outcomes
- Immunogenicity index-seropositive rate of neutralizing antibodies（CZ02 strain）(Day 28 after booster vaccination)
- Immunogenicity index-seroconversion rate of neutralizing antibodies（CZ02 strain）(Day 28 after booster vaccination)
- Immunogenicity index-GMI of neutralizing antibodies（CZ02 strain）(Day 28 after booster vaccination)
- Immunogenicity index-seropositive rate of neutralizing antibodies（Delta Strain）(Day 28 after booster vaccination)
- Immunogenicity index-seroconversion rate of neutralizing antibodies（Delta Strain）(Day 28 after booster vaccination)
- Immunogenicity index-GMI of neutralizing antibodies（Delta Strain）(Day 28 after booster vaccination)
- Immunogenicity index-seroconversion rate of neutralizing antibodies（Omicron Strain）(Day 28 after booster vaccination)
- Immunogenicity index-seropositive rate of neutralizing antibodies（Omicron Strain）(Day 28 after booster vaccination)
- Immunogenicity index-GMI of neutralizing antibodies（Omicron Strain）(Day 28 after booster vaccination)
- Immunogenicity index-GMT of neutralizing antibodies（Omicron Strain）(Day 28 after booster vaccination)
- Immunogenicity index-GMT of neutralizing antibodies（Delta Strain）(Day 28 after booster vaccination)