Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19
- Conditions
- COVID-19
- Interventions
- Biological: Medium-dose COVID-19 Vaccine(Vero Cell),InactivatedBiological: High-dosage of COVID-19 vaccine (Vero cell), Inactivated
- Registration Number
- NCT05165966
- Lead Sponsor
- Sinovac Life Sciences Co., Ltd.
- Brief Summary
This is a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months
- Detailed Description
This study a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated.The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months.A total of 340 subjects who have completed primary immunization using two-dose Coronavac® 5-9 months were be enrolled.All of subjects were be randomly divided into two groups in a 1:1 ratio to receive high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
- Healthy participants aged 18 years and above;
- 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 COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research & Development Co., Ltd and that is currently 5-9 months after the second dose.
- History of SARS-CoV-2 infection(laboratory confirmed);
- Have received three and more doses of inactivated COVID-19 vaccine;
- Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- 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;
- Participated in other clinical trials prior to enrollment and during the followup 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-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated 170 participants will receive one dose of booster vaccination with medium-dosage of COVID-19 vaccine (Vero cell), Inactivated. Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated High-dosage of COVID-19 vaccine (Vero cell), Inactivated 170 participants will receive one dose of booster vaccination with high-dosage of COVID-19 vaccine (Vero cell), Inactivated.
- Primary Outcome Measures
Name Time Method Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
- Secondary Outcome Measures
Name Time Method Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination Seropositivity rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
Trial Locations
- Locations (1)
Beijing Youan Hospital Capital Medical University
🇨🇳Beijing, Beijing, China