NCT04758273Unknown1 期
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 I Clinical Trial
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of adverse reactions/events
研究概览
简要总结
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ 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 degree 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 abnormal indicators, such as blood biochemistry, blood routine, urine routine and coagulation function which might show clinical meaning, before administration;
- •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.
结局指标
主要结局
Incidence of adverse reactions/events
时间窗: 0-28 days after each dose of vaccination
次要结局
- Serious Adverse Events (SAE)(within 12 months post full vaccination)
- Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function)(Day 3 after each dose of vaccination)
- The seropositive rates of SARS-CoV-2 neutralizing antibody(Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination)
- The seropositive level of SARS-CoV-2 neutralizing antibody(Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination)
- The seropositive rates of SARS-CoV-2 IgG antibody(tested by ELISA)(Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination)
- The seropositive level of SARS-CoV-2 IgG antibody(tested by ELISA)(Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination)
- The proportion of IFN-γ positive cells (by ELISpot)(Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group）)
- Level of IL-2、IL-4、IL-5、IL-6、TNFα、IFN-γ (by ELISA)(Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group）)
研究者
研究点 (1)
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