NCT05599516招募中3 期
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of LIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and BIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) in Healthy Population Aged 18 and Above
National Vaccine and Serum Institute, China2 个研究点 分布在 1 个国家目标入组 16,000 人开始时间: 2022年11月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16,000
- 试验地点
- 2
- 主要终点
- Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above.
研究概览
简要总结
This clinical trial adopts a randomized, double-blind and placebo-controlled design.
A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm.
Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.
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 range: healthy population aged ≥18;
- •Judged by the investigator that the health condition is well after inquiry and physical examination;
- •Cohort 1: participants vaccinated with ≥2 doses of inactivated COVID-19 vaccines for ≥6 months since the last dose of vaccination; Cohort 2: participants vaccinated with ≥2 doses of mRNA COVID-19 vaccines for ≥6 months since the last dose of vaccination;
- •Be able and willing to complete all prescribed study schedules during the whole study period;
- •The participant himself/herself is able and willing to understand study procedures, sign the informed consent form voluntarily after informed consent and comply to requirements of the study protocol.
排除标准
- •Symptomatic and suspected COVID 19 infection positive ;
- •Urine pregnancy test is positive; Women of childbearing age who have positive urine pregnancy test, who are pregnant, lactating, or women who have planned pregnancy within 6 months;
- •Auxiliary temperature before vaccination is ≥37.3℃ (tympanic/forehead temperature ≥37.8℃);
- •Previous allergy history of vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain, etc.) or allergy to known components of COVID-19 vaccine;
- •Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
- •With known immunological impairment or compromised immunological function diagnosed by the hospital;
- •Received whole blood, plasma and immunoglobulin therapy within 1 month;
- •Known or suspected of suffering from the following diseases: acute or chronic active respiratory diseases, severe cardiovascular diseases [cardiopulmonary failure, hypertension uncontrollable by drugs (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg)], acute infection, active phase of chronic disease, liver and kidney diseases, severe diabetes, malignant tumor, infectious skin diseases or severe skin allergy, HIV infection, etc. (Examination report can be provided)
- •Received live attenuated vaccine within one month before vaccination;
- •Received inactivated vaccine within 14 days before vaccination;
- •Other contraindications related to vaccination that investigators believe.
结局指标
主要结局
Cohort 1: Efficacy of LIBP-Rec-Vaccine/ BIBP-Rec-Vaccine against COVID-19 of immunization in healthy population aged 18 and above.
时间窗: 14th day after vaccination
Rates of cohort 1 subjects not infected with COVID-19
次要结局
- GMT of subject's anti-SARS-CoV-2 neutralizing antibody is non-inferior to that of Cohort 1（ LIBP-Rec-Vaccine / BIBP-Rec-Vaccine）(14th day after vaccination)
- GMI of subject's anti- SARS-CoV-2 neutralizing antibody(3th month、6th month after vaccination)
- The incidence and severity of unsolicited adverse reactions(within 0-7 days after vaccination)
- The incidence of AESI observed(Within 6 months of vaccination)
- The incidence and severity of solicited adverse reactions(within 8-30 days after vaccination)
- The incidence and severity of any adverse reactions(within 30 minutes after vaccination)
- The incidence and severity of solicited adverse events(within 8-30 days after vaccination)
- Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 asymptomatic infection in healthy population aged 18 and above(14th day after vaccination)
- Cohort 1: Efficacy of LIBP-Rec-Vaccine /BIBP-Rec-Vaccine against COVID-19 severe cases in healthy population aged 18 and above(14th day after vaccination)
- Cohort 1: Efficacy of LIBP-Rec-Vaccine / BIBP-Rec-Vaccine against COVID-19 related deaths in healthy population aged 18 and above.(14th day after vaccination)
- GMT of subject's anti- SARS-CoV-2 neutralizing antibody(3th month、6th month after vaccination)
- 4-fold increase rate of subject's anti- SARS-CoV-2 neutralizing antibody(3th month、6th month after vaccination)
- The incidence of SAE observed(Within 6 months of vaccination)
- Cross-neutralizing effect of recombinant COVID-19 vaccine against different variants (prototype strain, Delta, Omicron and other potential emerging dominant circulating variants)(14th day after vaccination)
研究者
研究点 (2)
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