NCT05124561撤回3 期
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Incidence of SAE
研究概览
简要总结
This phase III clinical trial is an endpoint-driven randomized, double-blind, parallel-controlled, multicenter clinical trial, and around 13,000 subjects aged 18 years and above who have previously received 1 dose of intramuscular Ad5-nCoV will be recruited. Volunteers should have been vaccinated with intramuscular Ad5-nCoV > 56 days prior to enrollment. All subjects will receive 1 dose of investigational vaccine or placebo through nebulized inhalation. The ratio of subjects in the vaccine group and placebo group is 1:1 and the efficacy and safety of the investigational vaccine will be followed up for 52 weeks after vaccination.
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
- •Adult volunteers aged 18 years and above who have received 1 dose of intramuscular Ad5-nCoV > 56 days at the enrollment.
- •Volunteers who have provided informed consent and signed the informed consent form.
- •Volunteers who are able and willing to comply with the requirements of the clinical study protocol, and can complete the entire follow-up period of this study.
排除标准
- •Allergic to the active ingredient, any non-active ingredient, or substances used in the manufacturing process, or developed an allergy to similar vaccines in the past.
- •History of severe anaphylactic reaction to vaccines (e.g., acute anaphylactic reactions, angioedema, dyspnea).
- •History or family history of seizures, epilepsy, encephalopathy, or psychosis.
- •Severe nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, throat redness, and swelling.
- •History of a definite diagnosis of COVID-
- •Positive SARS-CoV-2 N antibody rapid screening kit (IgG and IgM) results.
- •Received COVID-19 vaccine other than Ad5-nCoV.
- •Axillary temperature > 37.0°C.
- •Severe cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, or severe hypertension and cannot be controlled by drugs.
- •Lung function abnormalities such as asthma, chronic obstructive pulmonary disease, and pulmonary fibrosis.
- •Acute febrile illness, symptoms of upper respiratory tract infection, or infectious diseases.
- •Severe chronic diseases, or diseases of the progressive stage that cannot be steadily controlled, such as diabetes or thyroid disorders.
- •Asplenia or functional asplenia.
- •Thrombocytopenia or other coagulation disorder.
- •Received immunosuppressant or immunomodulatory therapy (continuous oral or intravenous infusion for more than 14 days), anti-allergic therapy, cytotoxic therapy within the past 6 months. Inhalational and local steroids are allowed.
- •Received blood products within 4 months before receiving the investigational vaccine.
- •Received other vaccines within the past 14 days or plan to receive other vaccines 14 days after scheduled immunization with the investigational vaccine.
- •Volunteers under antituberculous treatment or with active tuberculosis.
- •Received blood/plasma products or immunoglobulin 60 days before immunization with the investigational vaccine or planned to receive blood/plasma products or immunoglobulin during the entire study period.
- •Females who are positive for the urine pregnancy test, pregnant, or breastfeeding, or females who plan to conceive within 3 months (urine pregnancy test will only be performed in female volunteers of childbearing age).
- •Volunteers who are judged by the investigator with any contradiction to the study protocol or affected the signing of informed consent due to various medical, psychological,social, or other conditions.
研究组 & 干预措施
Placebo group
Placebo Comparator
6500 participants, placebo, single dose, nebulized inhalation
干预措施: Placebo (Biological)
Experimental group
Experimental
6500 participants, Ad5-nCoV-IH, single dose, nebulized inhalation
干预措施: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) (Biological)
结局指标
主要结局
Incidence of SAE
时间窗: Within 12 months post vaccination
Evaluate the incidence of severe adverse events (SAE)
Incidence of COVID-19 cases.
时间窗: Day 14 to 12 months post vaccination
The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.
次要结局
- Immunogenicity of neutralizing antibodies(Day 14, Day 28, Week 24, and Week 52 post-vaccination)
- Immunogenicity of S-RBD IgG antibody (ELISA method)(Day 14, Day 28, Week 24, and Week 52 post-vaccination)
- Incidence of COVID-19 cases(Day 28 to 12 months post vaccination)
- Incidence of Adverse Events (AEs)(Within 28 days post vaccination)
- Incidence of severe COVID-19 cases(Day 14 and Day 28 to 12 months post vaccination)
- Incidence of COVID-19 cases in different age groups(Day 14 and Day 28 to 12 months post vaccination)
- Incidence of Adverse Reactions (ARs)(Within 14 days post vaccination)
- Incidence of Adverse Reactions (ARs)(Within 30 minutes post vaccination)
研究者
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