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
试验速览
- 阶段
- 4 期
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental Group
600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine .
干预措施: High-dosage SARS-CoV-2 vaccine (Biological)
Control Group
600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .
干预措施: Medium-dosage SARS-CoV-2 vaccine (Biological)
结局指标
主要结局
Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）
时间窗: Day 28 after booster vaccination
GMT of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination.
次要结局
- 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)