A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18~59 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 744
- 试验地点
- 1
- 主要终点
- Safety indexes of adverse reactions
研究概览
简要总结
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
详细描述
This study is a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged 18~59 years. The purpose of this study is to evaluate the immunogenicity and safety of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 744 subjects will be enrolled, with 144 at phase Ⅰ, and 600 at phase Ⅱ. All of participants in phase Ⅰ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28.300 participants in phase Ⅱ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28 and one dose of booster immunization will be given 6 months after primary immunization of day 0,14 or day 0,28.The other 300 participants in phase Ⅱ will be assigned to receive three doses of experimental vaccine or placebo on the schedule of day 0,14,42 or 0,28,56 .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-59 years;
- •Proven legal identity;
- •Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;
排除标准
- •Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days;
- •History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
- •Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
- •Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
- •Self-reported history of SARS;
- •Self-reported history of new coronavirus infection;
- •Positive in serum antibodies (IgG or IgM) screening of COVID-19;
- •Positive in nasopharyngeal swabs or anal swabs through RT-PCR;
- •Women who are breastfeeding, pregnant or planning to become pregnant during the study period;
- •BMI≥35 kg/m2;
- •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 or immunodeficiency / immunosuppression;
- •Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and 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 non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- •Abnormal laboratory test results in the physical examination such as clinically significant abnormal hematology and biochemistry beyond the reference value range (only applicable to Phase I clinical trials);
- •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;
- •Attacks of acute diseases or chronic diseases in the past 7 days;
- •Axillary temperature >37.0°C;
- •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
Safety indexes of adverse reactions
时间窗: From Day 0 to Day 28 after each dose
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
Immunogenicity indexes of neutralizing-antibody seroconversion rates
时间窗: The 14th day /the 28th day after two doses of vaccination
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.
次要结局
- Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ(14 day (emergency schedule)/28 days (routine schedule) after the booster dose （only for days 0,14 and days 0,28 schedule）)
- Safety indexes of adverse reactions(7 days after each dose of vaccination)
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ(28 days after the third dose （only for days 0,14,42 and days 0,28,56 schedule）)
- Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies(7/14/21/28/42 days after the first dose vaccination (emergency schedule))
- Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies(28/35/42/56 days after the first dose vaccination (routine schedule))
- Safety indexes of serious adverse events (SAEs）(From the beginning of the vaccination to 6 months post the whole-schedule vaccination)
- Safety indexes of Incidence of abnormal laboratory index(On the 3th day after each dose of vaccination in phase Ⅰ)
- Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies(14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination)
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies(28 days after the two doses (emergency schedule))
- Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ(28/35/42 days after the first dose vaccination (routine schedules))