A Randomized, Double-blind, Dose-exploring, Placebo-controlled, Multi-center Phase I Clinical Trial Evaluating the Safety and Immunogenicity of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- The incidence of adverse reactions (AR)
研究概览
简要总结
To evaluate the safety and immunogenicity of the COVID-19 mRNA vaccine in people aged 18 years and older, 80 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group will be divided into 2 age groups (20 people each):18 to 59 years old and ≥ 60 years old. Subjects will be randomized into vaccine group or placebo group in a ratio of 3:1. Subjects will receive 2 doses of either vaccine or placebo on Day 0 and Day 21, in which the low-dose group will received 0.3 ml of the study vaccine or placebo, and the high dose group will receive 0.5 ml of the study vaccine or placebo.
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
- Quadruple (Participant, Care Provider, 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
- •Adults aged 18 years and above with BMI of 18 to 30 (including boundary values);
- •Volunteers are able and willing to comply with the requirements of the clinical trial protocol, and volunteers or witnesses can sign informed consent forms;
- •Willing to discuss the medical history with the investigator or doctor and allow access to all medical records related to this trial;
- •Provide 48-hour PCR negative report;
- •Have not received any other COVID-19 vaccines.
排除标准
- •Criteria for exclusion of the first dose
- •Other medical or psychiatric conditions, including recent (within the past year) or current presence of suicidal ideation/behavior, or laboratory abnormalities that may increase the risk of participating in the study, or subjects who are not suitable to participate in the study according to the investigator's judgment;
- •Positive for human immunodeficiency virus (HIV);
- •History of infection or disease of Middle East Respiratory Syndrome (MERS), SARS or other coronaviruses or related immunizations;
- •History of serious adverse reactions associated with the vaccine and/or a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine under study;
- •Immunocompromised patients with known or suspected immunodeficiency identified by medical history and/or physical examination;
- •Bleeding constitution or condition associated with prolonged bleeding which investigators believe that intramuscular injection is contraindicated;
- •Women who test positive for blood pregnancy or are breastfeeding, volunteers or their partners have a pregnancy plan within 12 months;
- •Severe hypertension and uncontrollable medication (on-site measurement: systolic blood pressure ≥ 160mmHg, diastolic blood pressure ≥ 100mmHg);
- •Have a serious chronic disease or the condition is in the progression period can not be smoothly controlled, such as diabetes, thyroid disease, etc.;
- •History of severe myocarditis, pericarditis and other heart diseases;
- •Abnormal laboratory tests during the screening window and judged by researchers to be of clinical significance;
- •Plans to receive other vaccines within 28 days before and after receiving the test vaccine;
- •Those receiving immunosuppressive therapy, including cytotoxic drugs or systemic corticosteroids, such as for cancer or autoimmune diseases, or who were scheduled to receive treatment throughout the study period. If systemic corticosteroids are used in a short period of time (< 14 days) for the treatment of acute illness, subjects should not enter this study until at least 28 days after corticosteroid therapy has been discontinued prior to study vaccination. Inhalation/spraying, intra-articular, intraskeletal, or topical (skin or eyes) use of corticosteroids is permitted;
- •Receiving blood/plasma products or immunoglobulins 60 days prior to study vaccination or plan to receive for the entire study duration;
- •Engage in other interventional studies within 28 days prior to entering the study and/or during the study's participation;
- •Participated in other interventional studies of lipid-containing nanoparticles;
- •Have symptoms of COVID-19 such as respiratory symptoms, fever, cough, shortness of breath, and dyspnea;
- •Fever, axillary temperature > 37.0 °C.
- •Second dose exclusion criteria:
- •Severe allergic reactions occur after the first vaccination;
- •Serious adverse reactions with causal relationship during the first vaccination;
- •Those who are newly discovered or newly occurring after the first vaccination do not meet the inclusion criteria of the first dose or meet the exclusion criteria of the first dose, and the investigator shall decide whether to continue to participate in the study;
- •Other reasons for exclusion that the investigators believe.
研究组 & 干预措施
Placebo Group, high dose, 60 year-old and above
2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21
干预措施: Placebo (Biological)
Vaccine Group, low dose, 18-59 year-old
2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21
干预措施: COVID-19 mRNA vaccine (Biological)
Vaccine Group, low dose, 60 year-old and above
2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21
干预措施: COVID-19 mRNA vaccine (Biological)
Vaccine Group, high dose, 18-59 year-old
2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21
干预措施: COVID-19 mRNA vaccine (Biological)
Vaccine Group, high dose, 60 year-old and above
2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21
干预措施: COVID-19 mRNA vaccine (Biological)
Placebo Group, low dose, 18-59 year-old
2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21
干预措施: Placebo (Biological)
Placebo Group, low dose, 60 year-old and above
2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21
干预措施: Placebo (Biological)
Placebo Group, high dose, 18-59 year-old
2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21
干预措施: Placebo (Biological)
结局指标
主要结局
The incidence of adverse reactions (AR)
时间窗: within 14 days of immunization
To evaluate the incidence of adverse reactions (AR) within 14 days of immunization in all subjects
次要结局
- The incidence of adverse reactions (AR)(Within 60 minutes of each vaccination)
- Changes in laboratory indicators(Day 4 and Day 7 post each vaccination)
- Immunogenicity of anti-S-RBD Ig G antibodies(Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose)
- The incidence of SAE, MAE and AESI(From vaccination to post of 12 months vaccination)
- Immunogenicity of wild type neutralizing antibodies(Before the 2nd dose, 14 days after the 2nd dose, and 28 days after the 2nd dose)
- Changes in vital signs(Day 1 to 4 , Day 7 after the first dose, and the day of second dose, Day 4 after the second dose, and day 7 after the second dose)
- Immuno-persistency of wild type neutralizing antibodies(Month 3,6 and 12 post second vaccination)