A Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cell), in Healthy Elderly Aged 60 Years and Above
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 1
- 主要终点
- Safety index-incidence of adverse reactions
研究概览
简要总结
This study is a randomized, double-blinded, and placebo controlled phase 1&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy elderly aged 60 years and above.
详细描述
This study is a randomized, double-blinded, single-center, placebo-controlled phase 1&2 clinical trial in healthy elderly aged 60 years and above. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 422 subjects will be enrolled, with 72 in phase 1 and 350 in phase 2. 72 Subjects with 36 in medium-dosage group and 36 in high-dosage group in phase 1 will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and the subjects at each dosage group will be assigned in a 2:1 ratio to receive investigational vaccine or placebo respectively.All enrolled subjects will receive 1 dose of booster immunization 1 year after primary immunization.350 Subjects in phase 2 will receive two doses of primary immunization according to the immunization schedule of day 0,28,the subjects will be assigned in a ratio of 2:2:2:1 to receive the low dosage, medium dosage, high dosage vaccine, or placebo. All enrolled subjects will received 1 dose of booster immunization(the third dose ) 6 months after primary immunization.And subjects in medium-dosage group and high -dosage group will receive the second booster dose (the fourth dose) 1 year after the second dose.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged ≥60 years;
- •Be able to understand and sign the informed consent voluntarily;
- •Provide legal identification;
排除标准
- •Travel / residence history of Wuhan city and surrounding areas or other communities with case reports within 14 days prior to the enrolment;
- •Contact with SARS-CoV-2 infected persons (positive for nucleic acid detection) within 14 days prior to the enrolment;
- •Contact patients with fever or respiratory symptoms from Wuhan city and surrounding areas, or from communities with case reports within 14 days prior to the enrolment;
- •Two or more cases of fever and / or respiratory symptoms in a small contact area of subjects, such as family, office, school class or other places within 14 days prior to the enrolment;
- •History of SARS;
- •History of SARS-CoV-2 infection;
- •History of asthma, allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
- •Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
- •Autoimmune disease or immunodeficiency / immunosuppression;
- •Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
- •Serious nervous system disease (epilepsy, convulsion or convulsion) or psychosis;
- •Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia 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;
- •Long history of alcohol or drug abuse;
- •Receipt of blood products 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;
- •Acute diseases or acute exacerbation of 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 the clinical trial.
研究组 & 干预措施
Experimental Vaccine-medium dosage
24 participants in medium-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in medium-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose ) and the second booster dose (the fourth dose) 1 year after the second dose.
干预措施: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 (Biological)
Experimental Vaccine-high dosage
24 participants in high-dosage group in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants in high-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose) and the second booster dose (fourth dose) 1 year after the second dose .
干预措施: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 (Biological)
Placebo
24 participants including 12 at medium dosage stage and 12 at high dosage in phase Ⅰ will receive two doses of placebo according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 50 participants in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
干预措施: Two doses of placebo at the schedule of day 0,28 (Biological)
Experimental Vaccine-low dosage
100 participants at low dosage stage in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
干预措施: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 (Biological)
结局指标
主要结局
Safety index-incidence of adverse reactions
时间窗: Day 0-28 after each dose vaccination
Incidence of adverse reactions after each dose vaccination
Immunogenicity index-seroconversion rates of neutralizing antibody
时间窗: 28 days after the second dose vaccination
The seroconversion rate of neutralizing antibody 28 days after the second dose vaccination.
次要结局
- Safety index-incidence rate of serious adverse events in phase Ⅰ(From the beginning of the vaccination to 6 months after the booster immunization)
- Safety index-incidence rate of serious adverse events in phase Ⅱ(From the beginning of the vaccination to 12 months after the booster immunization vaccination)
- Immunogenicity index-seropositive rate, GMT, and GMI of neutralizing antibodies(28 days after the second dose vaccination)
- Safety index-incidence rate of adverse reactions(within 7 days after each dose vaccination)
- Immunogenicity index-seroconversion rate, seropositive rate, GMT, and GMI in phase Ⅰ(28 days after the first dose vaccination in phase Ⅰ)