NCT04526990已完成3 期
A Global Multicenter, Randomized, Double-blind, Placebo -Controlled, Adaptive Designed Phase Ⅲ Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Ad5-nCoV in Adults 18 Years of Age and Older
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44,247
- 试验地点
- 138
- 主要终点
- Incidence of SAE
研究概览
简要总结
This study is a global multicenter, randomized, double-blind, placebo -controlled, adaptive designed phase Ⅲ clinical trial, in order to evaluate the efficacy, safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years old and above.
详细描述
This is a global phase III clinical trial to evaluate efficacy,safety, immuogenicity of Ad5-nCoV manufactured by Cansino and Beijing Institute of Biotechnology in health adults aged 18 years old and above.
The study will be double-blind, placebo-controlled trial with participants randomly allocated 1:1 to placebo and experimental vaccine cohorts.
The immunization schedule is one doses intramuscular injections (deltoid).
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 of 18 years old and above.
- •Participants who are at high risk of SARS-CoV-2 infection.
- •Able and willing (in the Investigator's opinion) to comply with all study requirements.
- •Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures.
- •Agreement to refrain from blood donation during the study.
- •provide written informed consent.
排除标准
- •Participation in any other COVID-19 prophylactic drug trials for the duration of the study.
- •Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
- •Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination.
- •Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data.
- •Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate.
- •Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination
- •Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus or SARS vaccines)
- •Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate
- •Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use.
- •History of allergic disease or reactions likely to be exacerbated by any component of Ad5-nCoV
- •Any history of angioedema
- •Any history of anaphylaxis to any vaccine component
- •Pregnancy, lactation or willingness/intention to become pregnant during the study
- •Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •History of serious psychiatric condition likely to affect participation in the study
- •Suspected or known current alcohol or drug dependency
- •Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness
- •History of laboratory-confirmed COVID-19
- •Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
结局指标
主要结局
Incidence of SAE
时间窗: Within 12 months
Evaluate the incidence of severe adverse events (SAE)
Incidence of COVID-19 cases
时间窗: day 28 to 12 months post vaccination
The efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) COVID-19 disease
次要结局
- Incidence of severe COVID-19 cases(Day 14 to 12 months post vaccination)
- Cell-mediated immune profile(Day 28 post vaccination)
- Incidence of unsolicited adverse events(Day 0-28 post vaccination)
- Incidence of solicited adverse reactions(Day 0-7 post vaccination)
- Immunogencity of S-RBD IgG antibody (ELISA method)(Day 28 post vaccination)
- Immunogencity of neutralizing antibody(Day 28 post vaccination)
研究者
研究点 (138)
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