Clinical Study on the Immunogenicity and Safety of the Recombinant Novel Coronavirus（COVID-19）Vaccine (CHO Cell) 0-1-6 Month and 0-1-4 Month Immunization Programs in People Aged 18 and Above
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Immunogenicity primary endpoint
研究概览
简要总结
Popular topic：Clinical study on the immune program of recombinant Novel Coronavirus (COVID-19) vaccine (CHO cell). Research purpose:Main purpose: To evaluate the immunogenicity of recombinant novel coronavirus vaccine (CHO cells) inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and over. Secondary purpose: To evaluate the safety of the investigational vaccine in people aged 18 and above.
Overall design: In this study, recombinant novel coronavirus vaccine (CHO cells) is inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and older to evaluate the immunogenicity and safety.
Study population:The study involved people 18 years of age and older. Test groups：A total of 300 subjects were enrolled, including 221 in the 18-59 age group and 79 in the ≥60 age group. Three doses of experimental vaccine were administered according to the 0,1,6 month immunization schedule (Study No. 001-150) or 0,1,4 months immunization schedule (Study No. 151-300).
详细描述
Overall design:In this study, recombinant novel coronavirus vaccine (CHO cells) is inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and older to evaluate the immunogenicity and safety.
Intervention: A total of 300 subjects were enrolled, including 221 in the 18-59 age group and 79 in the ≥60 age group. Three doses of experimental vaccine were administered according to the 0,1,6 month immunization schedule (Study No. 001-150) or 0,1,4 months immunization schedule (Study No. 151-300).
Immunogenicity observation:
About 5.0mL of venous blood was collected from all subjects for immunogenicity test before the first dose, before the third dose, on day 14 and 180 after full immunization.
Safety observation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Persons over the age of 18 with full capacity for civil conduct;
- •The subject voluntarily agrees to participate in the study and signs the informed consent, and can provide valid identification, understand and comply with the requirements of the study protocol;
- •Fertile male and female subjects of reproductive age agreed to use effective contraceptive measures from the beginning of the study to 2 months after full vaccination.
排除标准
- •Suspected or confirmed fever within 72 hours before enrollment, or armpit temperature ≥37.3℃ on the day of enrollment;
- •Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angiopantic edema, etc.; Or have a history of severe adverse reactions to any of the above mentioned vaccines or medications;
- •people who currently have or have a history of COVID-19;
- •Persons suffering from the following diseases:
- •① have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.;
- •② Congenital or acquired immune deficiency or autoimmune disease history or received immunomodulatory treatment within 6 months Treatment, such as immunosuppressive doses of glucocorticoid (dose reference: equivalent to prednisone 20mg/ day, more than one weeks); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical application (e.g. ointments, eye drops) is allowed Liquid, inhalant or nasal spray);
- •③ Have been diagnosed with a known infectious disease, such as active tuberculosis, viral hepatitis, human immunodeficiency virus or treponema pallidum;
- •④ Neurological disorders (e.g., convulsions, migraines, epilepsy, stroke, epileptic seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis); History of mental illness or family history;
- •⑤ functional absence of spleen, and absence of spleen or splenectomy caused by any reason;
- •⑥ There are serious chronic diseases or diseases in the progressive stage can not be controlled smoothly, such as diabetes, drugs can not control Hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
- •⑦ Severe liver and kidney diseases; Any current respiratory illness requiring routine medication (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any exacerbation of respiratory illness (e.g., exacerbation of asthma) within the last 5 years; A history of serious cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis;
- •⑧ Cancer patients (except basal cell carcinoma).
- •had taken an antipyretic or painkiller within 24 hours before the first dose of vaccine;
- •Those who have received novel coronavirus vaccine, or subunit vaccine and/or inactivated vaccine within 7 days before the first dose, or live attenuated vaccine within 14 days;
- •Have received blood or blood-related products, including immunoglobulin, within 3 months; Or planned for use during the study period;
- •Lactating or pregnant women (including women of childbearing age who have positive urine pregnancy test), or women who plan to have a pregnancy within 2 months after full vaccination of the test vaccine or their partners;
- •Have participated in or are currently participating in other COVID-19 related clinical trials;
- •The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.
结局指标
主要结局
Immunogenicity primary endpoint
时间窗: 14 days after full immunization
SARS-CoV-2 neutralizing antibody GMT
次要结局
- Immunogenicity secondary endpoint(180 days after full immunization)
- Safety endpoint(From the first dose to 6 months after full immunization)