A Randomized, Open, Control Phase ⅠV Clinical Trial, to Evaluate One Booster Immunization of Inactivated COVID-19 Vaccine (CoronaVac) or Original Vaccine in Adults Aged 18-45 Years Old Previously Vaccinated With Inactivated COVID-19 Vaccine From Difference Manufactures
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Immunogenicity index-seroconversion rate (4-fold and above increase)of neutralizing antibodies
研究概览
简要总结
This is a randomized, Open, control phase Ⅳ clinical trial of inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co., Ltd,Beijing institute of Biological Products Co.,Ltd and Wuhan Institute of Biological Products Co.,Ltd.The purpose of this study is to explore booster Immunization of SARS-CoV-2 Inactivated Vaccine from different manufactures in adults aged 18-45 years old Previously Vaccinated with inactivated COVID-19 vaccine
详细描述
This study a randomized, Open, control phase Ⅳclinical trial of inactivated COVID-19 vaccine .The purpose of this study is to explore booster Immunization of SARS-CoV-2 inactivated vaccine from different manufactures in adults aged 18-45 years old previously vaccinated with inactivated COVID-19 vaccine.A total of 480 subjects who have completed vaccination of two doses of inactivated COVID-19 vaccine for 6 to 8 months will be enrolled.In this study ,96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd.(experimental group 1).192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will be randomly divided into two groups (experimental group 2 and experimental group 3) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd. and Beijing institute of Biological Products Co., Ltd,respectively.192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.will be randomly divided into two groups(experimental group 4 and experimental group 5) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research & Development Co.,Ltd. and Wuhan Institute of Biological Products Co.,Ltd.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-45;
- •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 completed two doses of SARS-CoV-2 inactivated vaccine vaccination for 6 to 8 months(the interval between the two doses vaccine of primary immunization is 21~35 days, and the two doses vaccine of primary immunization should be manufactured by the same manufactures).
排除标准
- •History of SARS-CoV-2 infection(laboratory confirmed);
- •Have received inactivated SARS-CoV-2 vaccine from other manufacturers other than Sinovac Life Sciences Co., Ltd.,Beijing Institute of Biological Products Co.,Ltd.and Wuhan Institute of Biological Products Co.,Ltd.and 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 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 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.
结局指标
主要结局
Immunogenicity index-seroconversion rate (4-fold and above increase)of neutralizing antibodies
时间窗: 28 days after booster dose
Seroconversion rate (4-fold and above increase)of neutralizing antibodies 28 days after booster dose.
Immunogenicity index-seropositive rate of neutralizing antibody
时间窗: 28 days after booster dose
Seropositive rate of neutralizing antibody 28 days after booster dose.
Immunogenicity index-GMT of neutralizing antibodies
时间窗: 28 days after booster dose
GMT of neutralizing antibody 28 days after booster dose.
次要结局
- Safety index-Incidence of adverse reactions(0-7 days after booster dose)
- Safety index-Incidence of SAEs and AESIs(0-28 days after booster)