A Phase I/II Clinical Trial to Evaluate the Safety, Immunogenicity and Immune Persistence of COVID-19 mRNA Vaccine in Healthy People Aged 18 Years and Above.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- unsolicited adverse events
研究概览
简要总结
This clinical trial is a phase I/II clinical trial to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18 years and above.
详细描述
This is the clinical trial including an open-label, single-arm Phase I study and a subsequent randomized, blind, placebo-parallel controlled Phase II study to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18-60 years and ≥18 years respectively, whose locations or circumstances put them at appreciable risk of acquiring COVID-19 and/or SARS-CoV-2 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •People aged 18-60 years (both inclusive) for phase 1 and aged ≥18 years for phase 2；
- •Medical history and physical examination indicating as a healthy person;
- •The female participant or the spouse (or partner) of the male participant in child-birthing age agrees to use effective contraceptive measure throughout the whole course of this clinical trial.
- •Those who are participating in this clinical trial voluntarily, have signed the informed consent form, and been able to understand and comply with the requirements of the clinical trial protocol.
排除标准
- •Confirmed cases or history of SARS-CoV-2 infection;
- •Has a history of SARS and MERS virus infection;
- •Has fever (axillary temperature ≥37.3℃), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, and dyspnea within 14 days before vaccination;
- •Positive urine pregnancy test；
- •Axillary temperature ≥37.3℃ at the day vaccinated;
- •History of severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurosis, edema, etc.) or allergies to known components of COVID-19 mRNA vaccine;
- •History or family history of convulsions, epilepsy, encephalopathy, or mental illness;
- •Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- •Known suffering from diseases including: acute respiratory disease (such as flu-like illness, acute cough, sore throat), severe cardiovascular disease, kidney disease, uncontrolled hypertension (systolic blood pressure >150 mmHg, diastolic blood pressure >90 mmHg), diabetes complications, malignant tumor, all sorts of acute illness or chronic diseases acute phase;
- •Diagnosis with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune disease;
- •Abnormal coagulation function (such as lack of coagulation factor, coagulation disorders);
- •Receiving anti-tuberculosis treatment;
- •Long-term receipt (continuous≥7 days) of glucocorticoid (reverence value for dose: amount to≥20 mg/d prednisone equivalent), except inhaled, topical, nasal, aural and ophthalmic corticosteroids, within 6 months before screening; Receipt of immunotherapy or immunosuppressant within 3 months (continuous oral or infusion for more than 14 days);
- •Receipt of live attenuated vaccine within 28 days prior to vaccination and other vaccines within 14 days prior to vaccination;
- •Receipt of blood products within 3 months prior to vaccination
- •Receipt of other study drugs within 6 months prior to vaccination;
- •Receipt of any SARS-COV-2 vaccine;
- •Other situations judged by the investigators that are not suitable for participating in this clinical trial.
结局指标
主要结局
unsolicited adverse events
时间窗: up to 21 days and up to 28 days after the first and second dose of immunization, respectively
The incidence of unsolicited adverse events
The incidence of SAE
时间窗: up to 28 days after the full course of immunization
The incidence of SAE from the first dose of vaccination to 28 days after the full course of immunization
local/systemic solicited adverse reaction/events
时间窗: up to 6 days after each dose
The incidence of local/systemic solicited adverse reaction/events
次要结局
- The seroconversion rate, 2-fold or 4-fold rise and GMT/GMI of the SARS-COV-2 S-protein specific antibody (specific total antibody/IgG antibody) and neutralizing antibody(14 days after the full immunization)
- The incidence of SAE(the 29th ~365th day after the full course of immunization)
- Changes in laboratory abnormal parameters(after at least of one dose)