A Randomized, Double-blinded, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Immunogenicity of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy Adults Aged 18 Years and Above
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Incidence of unsolicited AEs after vaccination
研究概览
简要总结
The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels, administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age and above.
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, 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 individuals aged 18-59 years as well as 60 years and above who can provide legal identification (males and females are both required).
- •Willing to participate in the study with informed consent prior to screening
- •Negative in SARS-CoV-2 IgG and IgM test at screening.
- •Women of childbearing potential must be using effective method of birth control for 14 days prior to the enrollment of the study vaccine/placebo and must agree to continue such precautions during the study until 30 days after the second dose of the study vaccine/placebo.
- •Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 30 days after the second dose of the study vaccine/placebo.
排除标准
- •Confirmed or asymptomatic COVID-19 cases or SARS-CoV-2 infection(had positive in SARS-CoV-2 nucleic acid test or serological test).
- •Had a history of traveling or residence in domestic area of high and moderate pandemic risk, overseas or epidemic areas, or had a history of contact with confirmed, asymptomatic or suspected COVID-19 cases within the past 14 days;
- •History of SARS;
- •Received SARS-CoV-2 vaccines for emergency use or approved SARS-CoV-2 vaccines;
- •Individuals involving a clinical study within 6 months prior to the screening visit; or planning to participate in another clinical study during study period.
- •Clinical laboratory abnormalities and with clinical significance judged by investigator
- •Individual's systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 100mmHg at screening visit
- •Axillary temperature >=37.3℃ prior to vaccination
- •Individuals in other acute diseases, or in the acute phase of chronic diseases within 3 days prior to the signing of the informed consent form.
- •Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
- •Presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a high-risk category for SARS-CoV-2 infection and/or its complications as judged by the investigator..
- •Individuals with a history of severe allergic reaction (throat swelling, difficult in breath, dyspnea, or shock).
- •Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction [e.g., anaphylaxis to any component of the study vaccines (S protein, Aluminum hydroxide, CpG adjuvant).
- •Any autoimmune or immunodeficiency disease/condition [e.g. human immunodeficiency virus (HIV) infection, Systemic lupus erythematosus (SLE)]
- •Received immunoglobulin, blood-derived products within 3 months prior to the first study vaccination.
- •Abnormal coagulation function (such as coagulation factor deficiency, coagulation disease, platelet abnormality) obvious bruises or coagulopathy.
- •Pregnant women or breastfeeding women.
- •According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.
研究组 & 干预措施
Adult Group 1a
Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low adjuvant dose at Day 0 and Day 28
干预措施: 202-CoV low adjuvant dose (Biological)
Adult Group 1b
Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low antigen dose at Day 0 and Day 28
干预措施: 202-CoV low antigen dose (Biological)
Adult Group 1c
Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV standard dose at Day 0 and Day 28
干预措施: 202-CoV standard dose (Biological)
Adult Placebo
Adult healthy subjects (18 to 59 years of age, inclusive) receive 2 doses of placebo (saline) at Day 0 and Day 28
干预措施: Placebo (Other)
Elderly Group 1d
Adult healthy subjects (60 years of age and above) receive 202-CoV low adjuvant dose at Day 0 and Day 28
干预措施: 202-CoV low adjuvant dose (Biological)
Elderly Group 1e
Adult healthy subjects (60 years of age and above) receive 202-CoV low antigen dose at Day 0 and Day 28
干预措施: 202-CoV low antigen dose (Biological)
Elderly Group 1f
Adult healthy subjects (60 years of age and above) receive 202-CoV standard dose at Day 0 and Day 28
干预措施: 202-CoV standard dose (Biological)
Elderly Placebo
Adult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of unsolicited AEs after vaccination
时间窗: Frame: Day 0 to Day 56
Percentage of participants with unsolicited AEs for 28 days following each vaccination
Incidence of solicited adverse events (AEs) after vaccination
时间窗: 7 days after the first or second vaccination
Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 28) by intensity, relevance.
次要结局
- Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis and coagulation parameters(Day 4 after first or second vaccination)
- Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies(Day0, Day28, Day42 and Day56)
- Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies(Day0, Day28, Day42 and Day56)
- Geometric mean titer (GMT) of Serum IgG Antibody Levels(Day0, Day28, Day42 and Day56)
- Seroconversion rate (SCR) of Serum IgG Antibody Levels(Day0, Day28, Day42 and Day56)
- Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)(Day 0 to Month 13)