A Randomized, Blinded, Controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of a COVID-19 mRNA Vaccine (ZSVG-02-O) in a Healthy Population 18 Years of Age and Older
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 980
- 试验地点
- 2
- 主要终点
- Geometric mean titre (GMT) and 4-fold increasing rate of neutralizing antibodies (NAbs) against SARS-CoV-2 on 28 days after full vaccination
研究概览
简要总结
To evaluate the immunogenicity and safety of a COVID-19 mRNA vaccine (ZSVG-02-O) in a healthy population aged 18 years and older.
详细描述
This study uses a randomized, blinded and controlled design, with age stratification of 18-59 years and ≥60 years , including the test vaccine at different doses (30 μg and 60 μg) and an active control vaccine.
A total of 980 subjects will be enrolled in this study. 490 subjects aged 18-59 years will be randomly assigned to cohort A1 (test vaccine dose 1), A2 (test vaccine dose 2) and A3 (control vaccine) for the 2-dose regimen (0,28-day) and to cohort A4 (test vaccine dose 1), A5 (test vaccine dose 2) and A6 (active control) for the 1-dose regimen in a ratio of 3:3:1:3:3:1. Another 490 subjects aged 60 years or older will be randomized to cohort B1 (test vaccine dose 1), B2 (test vaccine dose 2) and B3 (active control) for the 2-dose regimen (0,28-day), and cohort B4 (test vaccine dose 1), B5 (test vaccine dose 2) and B6 (control vaccine) for the 1-dose regimen in a ratio of 3:3:1:3:3:1.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects aged ≥18 years of age;
- •Subjects who are in good physical condition as judged by the investigator based on medical history, physical examination and clinical laboratory tests;
- •Subjects who have not been previously vaccinated with a Covid-19 vaccine or who have received the last dose (total dose ≤ 3 doses) of a Covid-19 vaccine at least 6 months ago;
- •Subjects who have not been previously infected with Covid-19, or whose nucleic acid or antigen test has turned negative for more than 3 months after previous Covid-19 infection;
- •Subjects are able to understand the study procedures, have provide written informed consent, and are able to comply with the requirements of the clinical study protocol.
排除标准
- •Axillary temperature ≥37.3°C;
- •Positive polymerase chain reaction (PCR) test results within the last 48 hours;
- •Women of childbearing potential with a positive urine pregnancy test result, or who are pregnant or breastfeeding, or who have not used effective contraception within 2 weeks prior to enrolment, or women and men who plan to have children within 12 months after full immunisation;
- •History of epilepsy, convulsions or seizures, psychosis or family history of psychosis;
- •Have a history of severe allergy to any medication or vaccination (e.g. acute allergic reaction, urticaria, skin eczema, dyspnoea, angioneurotic oedema, or abdominal pain) or allergy to known components of a Covid-19 vaccine;
- •Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
- •Have a history of hospital-diagnosed known immunological impairment or hypofunction;
- •Subjects who have received whole blood, plasma or immunoglobulin therapy within 3 months;
- •Known or suspected concomitant serious diseases, including: respiratory diseases, acute infections or active chronic diseases, liver and kidney diseases, severe diabetes, malignant tumours, infectious or allergic skin diseases, and HIV infection (with test report);
- •Have serious cardiovascular diseases, cardiopulmonary failure, hypertension that cannot be controlled by medication (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg on physical examination);
- •Received live attenuated vaccine within 1 month prior to vaccination or other vaccines within 14 days prior to vaccination;
- •Participation in a clinical trial of another drug within 3 months prior to the first dose of vaccine or planning to participate in a clinical trial of another drug during the study period;
- •Any other conditions that the investigator considers inappropriate for participation in this study.
结局指标
主要结局
Geometric mean titre (GMT) and 4-fold increasing rate of neutralizing antibodies (NAbs) against SARS-CoV-2 on 28 days after full vaccination
时间窗: 28 days after full immunisation
Geometric mean titre (GMT) and 4-fold increasing rate of neutralizing antibodies (NAbs) against SARS-CoV-2 on 28 days after full vaccination
次要结局
- Incidence and severity of adverse event (AE) within 30 minutes of each dose of vaccination(From the start of each immunisation until 30 minutes after each immunisation)
- Proportion of NAbs against SARS-CoV-2 titres≥1:16, ≥1:32 and ≥1:64 on 14 and 28 days after full immunisation(14 days and 28 days after full immunisation)
- GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 7 days after the first immunisation(7 days after the first immunisation)
- Incidence and severity of adverse reactions/events 0-14 days after each dose of vaccination(Day 0~Day 14 after each immunisation)
- Incidence of serious adverse event (SAE) from the start of vaccination to 12 months after full vaccination(From the first dose of immunisation to 12 months after full immunisation)
- GMT and 4-fold increasing rate of NAbs against SARS-CoV-2 on 14 days after full vaccination(14 days after full immunisation)
- GMT, 4-fold increasing rate and ratio of antibody titres ≥1:16, ≥1:32 and ≥1:64 for NAbs against SARS-CoV-2 on 90 and 180 days after full immunisation(90 days and 180 days after full immunisation)
- Incidence and severity of adverse reactions/events 15-28 days after each dose of vaccination(Day 15~Day 28 after each immunisation)