Clinical Study on Immunogenicity and Safety of Recombinant Novel Coronavirus（COVID-19）Vaccine (CHO Cell) Combined With Tetravalent Influenza Virus Lysis Vaccine in People Aged 18 Years and Over
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Primary endpoint:
研究概览
简要总结
Popular topic：Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine. Study population:The study involved people 18 years of age and older.
Test groups:A total of 300 cases were enrolled. 240 patients in 18-59 years old group, 60 patients in ≥60 years old group. There were 150 cases in group A, 120 cases in 18-59 years old group, and 30 cases in ≥60 years old group. There were 150 cases in group B, 120 cases in 18-59 years old group and 30 cases in ≥60 years old group.
详细描述
Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine.
Intervention:
Group A: one dose of influenza virus split vaccine and one dose of recombinant Novel coronavirus vaccine (CHO cells) in the contralateral arm on day 0, the second dose of recombinant Novel coronavirus vaccine (CHO cells) on day 30, and the third dose of recombinant Novel coronavirus vaccine (CHO cells) on day 60 were given intramuscularly in the upper arm deltoid muscle.
Group B: the first dose of recombinant Novel coronavirus vaccine (CHO cells) was administered on day 0, the second dose of recombinant Coronavirus vaccine (CHO cells) on day 30, the first dose of influenza virus lysate vaccine on day 44, and the third dose of recombinant Coronavirus vaccine (CHO cells) on day 60.
One dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each dose, containing 25μg nCP-RBD protein. Influenza virus lysis vaccine, one dose at a time, each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg.
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
- 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
- •Healthy subjects aged 18 and above with full capacity for civil conduct, who can provide valid identification;
- •The subjects voluntarily agree to participate in the study and sign the informed consent to understand and comply with the requirements of the study protocol;
- •Fertile men and women of reproductive age did not have sex from day 1 of the last menstrual cycle to day 1 of the study, or did not have sex using effective contraceptive methods and did not experience contraceptive failure (examples of contraceptive failure include male condom rupture during sex). At the same time, subjects agreed to take effective contraceptive measures for 1 month from the signing of informed consent to the full immunization and no pregnancy plans during this period.
排除标准
- •History of novel coronavirus infection confirmed or asymptomatic infected persons or positive nucleic acid test of novel Coronavirus;
- •SARS virus history;
- •For those with fever, axillary temperature ≥37.3℃ on the day of inclusion;
- •A past history of severe allergy to any vaccine, or to the active ingredient of the test vaccine, any inactive ingredient, or substance used in the manufacturing process, including aluminum preparations, egg protein, neomycin, formaldehyde, tritonX-100, such as: Acute anaphylaxis, dyspnea, angioneurotic edema, etc., or allergies during previous vaccinations of the same kind;
- •Patients with uncontrolled epilepsy and other serious neurological diseases (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.);
- •Patients with acute diseases, or acute episodes of chronic diseases, or uncontrolled severe chronic diseases (such as hypertension that cannot be controlled by drugs, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
- •Patients at the active stage of autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, sjogren's syndrome, etc.), patients with congenital or acquired immune deficiency, HIV infection with opportunistic infection or uncontrolled malignant tumor, lymphoma and leukemia;
- •No spleen, or splenic operation history;
- •Received immunomodulators within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical use (such as ointments, eye drops, inhalants or nasal sprays) is allowed;
- •Has received blood or blood-related products, including immunoglobulin (including rabies immunoglobulin and tetanus immunoglobulin), within 3 months prior to experimental vaccine vaccination; Or planned use of the experimental vaccine within 1 month of vaccination;
- •If subunit vaccine and inactivated vaccine are administered within 7 days prior to experimental vaccine inoculation, live attenuated vaccine shall be administered within 14 days prior to experimental vaccine inoculation;
- •Lactating women or pregnant women (including women of childbearing age with positive urine pregnancy test);
- •Those who have participated in or are participating in clinical trials related to COVID-19, or are participating in clinical trials of other drugs, or have received COVID-19 vaccines; 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
Primary endpoint:
时间窗: 14 days after vaccination
Positive conversion rate of SARS-COV-2 neutralizing antibody at day 14 after full inoculation of recombinant Novel Coronavirus vaccine (CHO cells).
次要结局
- Secondary endpoint:(1 months after full vaccination)