Single-center, Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells) in Healthy People Aged 6-17 Years
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Phase I clinical trial：The incidence of adverse reactions (ARs) .
研究概览
简要总结
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).
详细描述
This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg). The phase Ⅰ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 30 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 120 in total. The phase Ⅱ clinical trials designed 4 research group, including immunization procedures 0, 21 42 days , three doses (10μg/0.25ml, 20μg/0.5ml, 40μg/1.0ml) and two ages group (6-11 and 12-17years): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 2:1 ratio, 480 in total.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 6-17 years；
- •The subject and/or guardian can understand and voluntarily sign the informed consent form (double signature is required for 8-17 years old)；
- •Reproductive women have a negative pregnancy test before each vaccination；
- •The subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 13.5 months.
排除标准
- •History of SARS-CoV-2 infection.
- •The COVID-19 antibody (IgG and IgM) screening was positive.
- •History of asthma, history of allergy to vaccines or vaccine components, or severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioedema.
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •Autoimmune diseases or immunodeficiency/immunosuppression.
- •Severe chronic diseases that cannot be controlled by drugs, severe cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc.
- •Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness.
- •Any condition caused by thyroid disease or history of thyroidectomy, hypersplenism, or splenectomy.
- •Diagnosis of abnormal blood clotting function (for example, lack of clotting factors, coagulopathy, abnormal platelets) or obvious bruising or blood clotting.
- •In the past 6 months, received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and superficial corticosteroid therapy for acute uncomplicated dermatitis).
- •Laboratory test results with clinically significant abnormalities (severity level 2 and above) (applicable to phase I clinical trials only).
- •Received blood products in the last 3 months.
- •Receive other study drugs or vaccines within the past 30 days.
- •Vaccination against live attenuated vaccines in the past 30 days.
- •Inactivated vaccine or subunit vaccine in the past 14 days.
- •Acute disease or acute exacerbation of chronic disease in the last 7 days.
- •Axillary temperature> 37.0°C.
- •According to the judgment of the investigator, the subject has other factors that are not suitable for participating in the clinical trial.
- •Subsequent dose exclusion criteria:
- •In this trial, the second/third dose of vaccination may be stopped in some cases. This includes allergic reactions, severe hypersensitivity reactions, or grade 3 or higher adverse reactions that cannot be tolerated after previous vaccination/placebo. If these reactions occur, the subject should not continue to receive the second/third vaccination.
研究组 & 干预措施
Low-dose vaccine (6-11 years)
three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.
干预措施: Recombinant COVID-19 vaccine (Sf9 cells) (Biological)
Medium-dose vaccine (6-11 years)
three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.
干预措施: Recombinant COVID-19 vaccine (Sf9 cells) (Biological)
Medium-dose vaccine (12-17 years)
three doses of medium-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.
干预措施: Recombinant COVID-19 vaccine (Sf9 cells) (Biological)
High-dose vaccine (12-17 years)
three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21，42.
干预措施: Recombinant COVID-19 vaccine (Sf9 cells) (Biological)
High-dose placebo (12-17 years)
three doses of high-dose placebo at the schedule of day 0, 21，42.
干预措施: Placebo control (Other)
Low-dose placebo (6-11 years)
three doses of low-dose placebo at the schedule of day 0, 21，42.
干预措施: Placebo control (Other)
Medium-dose placebo (6-11 years)
three doses of medium-dose placebo at the schedule of day 0, 21，42.
干预措施: Placebo control (Other)
Medium-dose placebo (12-17 years)
three doses of medium-dose placebo at the schedule of day 0, 21，42.
干预措施: Placebo control (Other)
结局指标
主要结局
Phase I clinical trial：The incidence of adverse reactions (ARs) .
时间窗: Day 0-7 days after each vaccination.
Adverse reactions (ARs) in each dose group 0-7 days after each vaccination.
Phase II clinical trial：The incidence of adverse reactions (ARs) .
时间窗: Day 0-7 days after each vaccination.
Adverse reactions (ARs) in 0-7 days after each vaccination.
Phase II clinical trial：The geometric mean titer(GMT) of specific antibody.
时间窗: Day 30 after completion of 3 doses vaccination
The geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus).
次要结局
- Phase I clinical trial：The positive conversion rate of anti-COVID-19 S-RBD protein specific antibody.(Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination)
- Phase I clinical trial：the geometric mean increase multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody.(Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination)
- Phase I/II clinical trial：The incidence of adverse events (AEs) in all participants.(Day 0 to 30 days after completion of 3 doses vaccination)
- Phase I clinical trial：Changes in laboratory test indicators(within 7 days before the first vaccination and on the 3rd day after each vaccination)
- Phase I clinical trial：The geometric mean titer (GMT) / positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody(Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination)
- Phase I/II clinical trial：The incidence of adverse events (AEs)(Day 0-7 days after each vaccination.)
- Phase I/II clinical trial：The incidence of serious adverse events(SAEs) in all participants.(Day 0 to 12 months after completion of 3 doses vaccination)
- Phase I clinical trial：The geometric mean titer (GMT) of anti-COVID-19 S-RBD protein specific antibody(Day 14, Day 30，month 3, month 6, and month 12 after completion of 3 doses vaccination)
- Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 S-RBD protein specific antibody(Day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination)
- Phase II clinical trial：The positive conversion rate/geometric mean growth multiple (GMI) of anti-COVID-19 specific neutralizing antibody(Day 14, Day 30, month 6, and month 12 after completion of 3 doses vaccination)