NCT05293548进行中（未招募）2 期
A Randomized, Controlled Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell) in Population Aged 18 Years and Above
National Vaccine and Serum Institute, China2 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2022年5月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 516
- 试验地点
- 2
- 主要终点
- the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
研究概览
简要总结
A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.
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
- 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
- •Age: population aged 18 years and above;
- •Judged by the investigator that the health condition is well after inquiry and physical examination;
- •Vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine (Vero Cell vaccine) 6 months prior to study screening and according to product insert;
- •Female participants who are not pregnant or nursing or at the time of enrolment (confirmed via negative urine pregnancy test), and do not have plans to become pregnant within the first 6 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before study inclusion and initiation;
- •Be able and willing to provide written informed consent to participate in the study and complete all study requirements according to the study protocol;
排除标准
- •COVID-19 infection positive patients (including suspected or asymptomatic cases);
- •Have a history of SARS and MERS infection;
- •Have been vaccinated by any COVID-19 Vaccines other than Vero Cell vaccine；
- •Have an axillary temperature 37.3 (forehead temperature 37.8℃℃);
- •Have had previous allergic reactions to vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic oedema or abdominal pain) or allergy to known components of COVID-19 vaccine;
- •History of thrombocytopenia or other coagulation disorders;
- •Patients with known immunological impairment or immunocompromised.
- •Received whole blood, blood products, plasma and/or immunoglobulin therapy within 3 months before study enrollment
- •Have known or suspected severe illness such as respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumour, infectious or allergic skin disease, human immunodeficiency virus (HIV) infection (test report available);
- •Diagnosed with serious cardiovascular diseases such as cardiopulmonary failure, drug-uncontrolled hypertension (Systolic blood pressure 160 mmHg and/or diastolic blood pressure 95 mmHg).
- •Received live attenuated vaccines within 1 month before study enrollment;
- •Received inactivated vaccines within 14 days before study enrollment;
- •Received other investigational drugs within 6 months before study enrollment;
- •Other vaccination-related contraindications considered by investigators.
结局指标
主要结局
the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
时间窗: 14 days after a single dose of the booster vaccine
The incidence rate of any adverse reactions/events
时间窗: within 30 minutes after vaccination
The incidence rate of solicited adverse reactions/events
时间窗: within 8-30 days after vaccination
The incidence of AESI observed
时间窗: up to 12 months after full course of immunization
GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
时间窗: 14 days after sequential immunization of one booster dose
The incidence severity of solicited adverse reactions/events
时间窗: within 8-30 days after immunization
The incidence of SAE observed
时间窗: up to 12 months after full course of immunization
The incidence severity of any adverse reactions/events
时间窗: within 30 minutes after vaccination
次要结局
- 4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age(28 days after sequential immunization of one booster dose)
- 4-fold rise rate of anti-omicron IgG antibody in adults ≥18 years of age(before booster vaccination and 28 days after a single dose of the booster vaccine)
- 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age(28 days after sequential immunization of one booster dose)
- GMT of anti-omicron IgG antibody in adults ≥18 years of age(before booster vaccination and 28 days after a single dose of the booster vaccine)
- proportions of neutralizing antibody tittered 1: 16, 1: 32 and 1: 64 of anti-SARS-CoV-2 IgG antibody in adults ≥18 years of age(before booster vaccination and 28 days after a single dose of the booster vaccine)
- IgG antibody of anti-omicron neutralizing antibody(3 months, 6 months, 9 months and 12 months after sequential immunization)
- GMT of anti-omicron neutralizing antibody in adults ≥18 years of age(28 days after sequential immunization of one booster dose)
- GMI of anti-omicron IgG antibody in adults ≥18 years of age(before booster vaccination and 28 days after a single dose of the booster vaccine)
- the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64(3 months, 6 months, 9 months and 12 months after sequential immunization)
- GMTs of anti-omicron neutralizing antibody(3 months, 6 months, 9 months and 12 months after sequential immunization)
研究者
研究点 (2)
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