A Randomized, Open, Positive Controlled Clinical Study to Evaluate the Immunogenicity and Safety of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) in People Aged 18 Years and Over
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Immunogenicity end point 1
研究概览
简要总结
Popular topic:A Clinical Study of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) Overall design:The study was designed as a randomized, open and controlled study.
Study population: People aged 18 years and above and 6-15 months after the completion of basic immunization or 6-9 months after the completion of enhanced immunization with the new coronal prototype vaccine.
Test groups:Study group；Control group；Observation group ①；Observation group ②
详细描述
Research topic: A randomized, open, positive controlled clinical study to evaluate the immunogenicity and safety of the recombinant novel coronavirus protein vaccine (CHO cell) of Omicron-Delta strain in people aged 18 years and above.
Product name:Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell),each dose contains 25μg DO-RBD protein/0.5mL/bottle.
Indications: Prevention of respiratory diseases caused by new coronavirus infection.
Research purpose:
Main purpose:To evaluate the immunogenicity of Omicron Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against new crown variants (Delta, Omicron BA. 2，Omicron BA. 5) in people aged 18 years 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
- 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
- •At the time of signing the Informed Consent, he was 18 years old or above;
- •Normal body temperature (axillary temperature < 37.3 ℃/oral temperature < 37.5 ℃);
- •Meet one of the following conditions: 1) 6-15 months after the basic immunization (2 injections) of the inactivated vaccine of the prototype strain of COVID-19-19 has been completed; 2) 6-9 months after the booster immunization (3 injections) of the inactivated vaccine of the prototype strain of COVID-19 has been completed; 3) 6-15 months after basic immunization (3 injections) of recombinant vaccine of COVID-19 prototype strain has been completed.
- •The vaccines used to complete the above basic immunization or enhanced immunization were produced by Beijing Biotech, Wuhan Biotech, Sinovac and Zhifeilong Koma, and the same kind of vaccine was inoculated throughout the whole process.
- •Female subjects over 18 years old were not pregnant (blood pregnancy test was negative), were not in lactation and took effective contraceptive measures within 4 weeks after inoculation; The male subject must agree to take effective contraceptive measures by himself and his partner within 4 weeks after signing the informed consent and vaccination.
- •Subjects have the ability to understand the research procedure, voluntarily sign the informed consent form after informed consent, can comply with the requirements of the clinical research protocol, and can and is willing to complete the entire required research plan.
排除标准
- •A history of serious allergy to any vaccine in the past, or a history of serious allergy to any component of the studied vaccine, including aluminum preparations, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, allergic constitution (such as allergic to two or more drugs, food or pollen);
- •Confirmed cases of novel coronavirus infection, asymptomatic infections or positive history of novel coronavirus nucleic acid testing;
- •Patients with uncontrollable lymphoproliferative disease, aplastic anemia, primary immune thrombocytopenia (ITP), and haemorrhagic disease;
- •A history of congenital or acquired immunodeficiency or autoimmune diseases;
- •The life expectancy of patients with malignant tumors is less than 1 year;
- •Patients with uncontrolled epilepsy and other progressive nervous system diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
- •Patients with acute disease, or acute attack period of chronic disease, or uncontrolled severe chronic disease, such as hypertension beyond the control of drugs (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- •Those who have received inactivated vaccine within one week or attenuated vaccine within four weeks before vaccination;
- •Subjects who have participated in other clinical studies or are participating in other clinical studies within 3 months;
- •The investigator believes that the subject has any disease or condition that may put the subject at risk, that the subject cannot complete the study as required by the protocol, and that there are conditions that interfere with the evaluation of vaccine response.
结局指标
主要结局
Immunogenicity end point 1
时间窗: 14 days after vaccination
Blood samples were collected from subjects on the 14th day after vaccination, and serum was obtained after centrifugation. Then, the geometric mean titer (GMT) of neutralizing antibodies against COVID-19 variants (Delta, Omicron BA.2，Omicron BA.5) was obtained from the serum samples of subjects on the 14th day after vaccination.
Safety end point 1
时间窗: 28 days after vaccination
The contact card was recovered on the 28th day after vaccination, and the clinician determined whether there was an adverse event and entered it into the EDC system. After statistical analysis, the incidence of all adverse events within 28 days was determined.
Safety end point 2
时间窗: 6 months after vaccination
At the end of 6 months after vaccination, through telephone follow-up, the clinician learned whether the subject had serious adverse events, entered the information into the EDC system, and determined the incidence of all serious adverse events within 6 months through statistical analysis.
次要结局
- Immunogenicity end point 4(6 months after vaccination)