Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19
- Conditions
- COVID-19
- Interventions
- Biological: High-dosage SARS-CoV-2 vaccineBiological: Medium-dosage SARS-CoV-2 vaccine
- Registration Number
- NCT05079217
- Lead Sponsor
- Sinovac Biotech Co., Ltd
- 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 .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1200
- 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.
- 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;
- Receipt of other investigational drugs in the past 30 days;
- Receipt of attenuated live vaccines in the past 14 days;
- Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
- Axillary temperature >37.0°C;
- Already pregnant or are breastfeeding, planning to get pregnant within 1months (according to subjects' self-report and urine pregnancy test results);
- 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;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group High-dosage SARS-CoV-2 vaccine 600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine . Control Group Medium-dosage SARS-CoV-2 vaccine 600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Xinqi City Center for Disease Control and Prevention
🇨🇳Xinqi, Jiangsu, China