Evaluation of the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above: a Randomized, Double-blind, Placebo Parallel-controlled Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The seropositive rates of SARS-CoV-2 neutralizing antibody
研究概览
简要总结
This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy permanent residents aged 18 years and above;
- •Subjects agree to sign the informed consent forms voluntarily;
- •Subjects are able to comply with the requirements of the clinical trial protocol;
- •Armpit temperature <= 37.0 degrees C;
- •Female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures had been taken within 2 weeks before enrollment.
排除标准
- •Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;
- •Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
- •Subjects with history of SARS virus infection by self-reported;
- •Positive in throat swab through RT-PCR;
- •Positive in SARS-CoV-2 antibody test;
- •Subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;
- •Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history;
- •Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- •Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmHg, diastolic pressure >= 90 mmHg; subjects aged >= 60 years with systolic pressure >=150 mmHg, diastolic pressure >=100 mmHg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;
- •Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- •Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
- •Subjects receiving anti-TB treatment;
- •Subjects receiving other research drugs within 6 months before vaccination;
- •Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
- •Subjects receiving blood products within 3 months before administration;
- •Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
- •Subjects vaccinated with other vaccine within 7 days before vaccination;
- •The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
研究组 & 干预措施
medium dosage on day 0, 28(18~59 years)
Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28
干预措施: medium dosage inactivated SARS-CoV-2 vaccine (Biological)
high dosage on day 0, 28(18~59 years)
Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28
干预措施: high dosage inactivated SARS-CoV-2 vaccine (Biological)
high dosage on day 0, 14(18~59 years)
Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
干预措施: high dosage inactivated SARS-CoV-2 vaccine (Biological)
placebo on day 0, 14(18~59years)
Two doses of placebo on the schedule of day 0,14
干预措施: Placebo (Biological)
medium dosage on day 0, 14(18~59 years)
Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
干预措施: medium dosage inactivated SARS-CoV-2 vaccine (Biological)
placebo on day 0, 28(18~59years)
Two doses of placebo on the schedule of day 0,28
干预措施: Placebo (Biological)
medium dosage on day 0, 28, 56(18~59 years)
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
干预措施: medium dosage inactivated SARS-CoV-2 vaccine (Biological)
high dosage on day 0, 28, 56(18~59 years)
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
干预措施: high dosage inactivated SARS-CoV-2 vaccine (Biological)
placebo on day 0, 28, 56(18~59 years)
Three doses of placebo on the schedule of day 0,28,56
干预措施: Placebo (Biological)
medium dosage on day 0, 28, 56(>59 years)
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
干预措施: medium dosage inactivated SARS-CoV-2 vaccine (Biological)
high dosage on day 0, 28, 56(>59 years)
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
干预措施: high dosage inactivated SARS-CoV-2 vaccine (Biological)
placebo on day 0, 28, 56(>59 years)
Three doses of placebo on the schedule of day 0,28,56
干预措施: Placebo (Biological)
结局指标
主要结局
The seropositive rates of SARS-CoV-2 neutralizing antibody
时间窗: Day 28 post full vaccination
The seropositive level of SARS-CoV-2 neutralizing antibody
时间窗: Day 28 post full vaccination
The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA)
时间窗: Day 28 post full vaccination
次要结局
- Level of SARS-CoV-2 IgG antibody (tested by ELISA)(Day 28 post full vaccination)
- Incidence of adverse reactions/events(0-28 days after each dose of vaccination)
- Serious Adverse Events (SAE)(within 12 months post full vaccination)
- The seropositive rates of SARS-CoV-2 neutralizing antibody(Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups)
- The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA)(Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups)
- The seropositive level of SARS-CoV-2 neutralizing antibody(Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups)
- The seropositive level of SARS-CoV-2 IgG antibody (tested by ELISA)(Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups)