A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac） in Health Adults Aged 26-45 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population
研究概览
简要总结
This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac）manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of CoronaVac in healthy adults aged 26-45 years.
详细描述
This study is a double-blind, randomized phase Ⅳ clinical trial in healthy adults aged 26-45 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy adults aged 26-45 years .The experimental vaccine was manufactured by Sinovac Research & Development Co.,Ltd. A total of 1080 healthy subjects aged 26 to 45 years old will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received two doses of vaccine on day 0 and day 28.
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
- 26 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 26-45;
- •The subjects can understand and voluntarily sign the informed consent form ;
- •Proven legal identity.
排除标准
- •Travel history / residence history of communities with case reports within 14 days prior to the study;
- •History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days prior to the study;
- •Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days prior to the study;
- •Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days prior to the study;
- •History of SARS-CoV-2 infection or receiving COVID-19 vaccine;
- •History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- •Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation)
- •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;
- •Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
- •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;
- •Receipt of inactivated or subunit vaccines in the past 7 days;
- •Onset of various acute or chronic diseases within 7 days prior to the study;
- •Axillary temperature >37.0°C;
- •Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 months;
- •The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
- •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
Inactivated SARS-CoV-2 vaccine Lot 1
Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 1 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell） (Biological)
Inactivated SARS-CoV-2 vaccine Lot 2
Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 2 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell） (Biological)
Inactivated SARS-CoV-2 vaccine Lot 3
Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 3 according to 0,28-day immunization schedule.
干预措施: Inactivated SARS-CoV-2 Vaccine (Vero cell） (Biological)
结局指标
主要结局
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population
时间窗: Day 28 after the second dose
GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population
次要结局
- GMT of the neutralizing antibody to live SARS-CoV-2 in total population(Day 28 after the second dose)
- GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population(Day 28 after the second dose)
- Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population(Day 28 after the second dose)
- Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population(Day 28 after the second dose)
- Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population(Day 28 after the second dose)
- Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population(Day 28 after the second dose)
- Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population(Day 28 after the second dose)
- Seroconversion rate of anti-SARS-CoV-2 S antibody(Day 28 after the second dose)
- Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody(Day 28 after the second dose)
- Incidence of adverse reactions after vaccination(From the beginning of the vaccination to 28 days after the second dose)
- Seropositivity rate of anti-SARS-CoV-2 S antibody(Day 28 after the second dose)
- GMI of anti-SARS-CoV-2 S antibody(Day 28 after the second dose)