A Randomized, Double-blind, Placebo-Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV for Inhalation in Adults 18 Years of Age and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Reactions (AR)
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled I/II clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation in adults 18 years of Age and Older.
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
- •Healthy adults 18 years of age and above at the time of enrollment;
- •Able to provide consent to participate in and having signed an Informed Consent Form (ICF);
- •Able and willing to complete all the scheduled study procedures during the whole study follow-up period;
- •HIV negative;
- •No nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, sore throat, etc;
- •IgG ang IgM negative for Covid-19;
- •Axillary temperature ≤37.0℃;
- •No contact history of Covid-19.
排除标准
- •Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medications (on-site measurement: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), etc;
- •Abnormal laboratory test indicators which investigator decide to be clinically significant; (Only Phase I volunteers)
- •Respiratory rate ≥17 per minute;
- •Abnormal lung function such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, etc;
- •Prior Covid-19 vaccinations;
- •Symptoms of upper respiratory track infections;
- •Medical or family history of convulsions, epilepsy, encephalopathy, and psychosis disorders;
- •History of allergies to any ingredient of Ad5-nCoV, history of serious allergic reactions to any vaccine, history of allergies and immune diseases;
- •Acute febrile diseases and infectious diseases;
- •Medical history of SARS (SARS-CoV-1);
- •Severe chronic diseases or with advanced stage conditions which cannot be controlled smoothly, such as diabetes, thyroid disease, etc;
- •Congenital or acquired angioedema/neurological edema;
- •Urticaria history within 1 year before receiving the study vaccine;
- •Asplenia or functional asplenia;
- •Thrombocytopenia or other coagulation disorders (may cause contraindications for intramuscular injection);
- •Trypanophobia in intramuscular injection groups;
- •History of receiving immunosuppressant therapy (continuous oral or instillation for more than 14 days), anti-allergic therapy, cytotoxic therapy, nebulized corticosteroid therapy in the past 6 months;
- •Prior administration of blood products in last 4 months;
- •Other vaccination(s) or investigational drugs within 1 month before study onset, or planned use during the study period;
- •Prior administration of live attenuated vaccine within 1 month before study onset;
- •Prior administration of subunit or inactivated vaccine within 14 days before study onset;
- •Current anti-tuberculosis therapy;
- •Women who are pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the whole study;
- •Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives or informed consent (i.e. medical, psychological, social or other conditions, etc.) Exclusion criteria for the phase II portion of the study will be detailed in an amended synopsis/study protocol.
研究组 & 干预措施
B3b Phase II placebo high 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Placebo for Inhalation (Biological)
B4a Phase II combine 2 doses
1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
A1a Phase I low 2 doses
Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
A1b Phase I placebo low 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Placebo for Inhalation (Biological)
A2a Phase I medium 2 doses
Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
A2b Phase I placebo medium 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Placebo for Inhalation (Biological)
A3a Phase I high 2 doses
Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
A3b Phase I placebo high 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Placebo for Inhalation (Biological)
A4a Phase I combine 2 doses
1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
A4a Phase I combine 2 doses
1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Biological)
B1b Phase II placebo low 2 doses (18-59)
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Placebo for Inhalation (Biological)
B2a Phase II medium 2 doses
Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
B3a Phase II high 2 doses
Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
B2b Phase II placebo medium 2 doses
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Placebo for Inhalation (Biological)
A4b Phase I placebo combine 2 doses
6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
干预措施: Placebo for Inhalation (Biological)
A4b Phase I placebo combine 2 doses
6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
干预措施: Placebo (Biological)
A5a Phase I single dose
Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
A5b Phase I placebo single dose
6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo
干预措施: Placebo for Inhalation (Biological)
B1a Phase II low 2 doses
Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
B4a Phase II combine 2 doses
1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Biological)
B4b Phase II placebo combine 2 doses
Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
干预措施: Placebo for Inhalation (Biological)
B4b Phase II placebo combine 2 doses
Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
干预措施: Placebo (Biological)
B5a Phase II intramuscular single dose
Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Biological)
B5b Phase II placebo intramuscular single dose
placebo containing 0 vp, 1 dose Intramuscular Injection
干预措施: Placebo (Biological)
B6a Phase II Aerogen Solo single dose
Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation (Biological)
B6b Phase II placebo Aerogen Solo single dose
placebo containing 0 vp, 1 dose Aerogen Solo
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Biological)
结局指标
主要结局
Incidence of Adverse Reactions (AR)
时间窗: 0-14 days after each vaccination
The occurrence of Adverse Reactions (AR) in all groups
Incidence of Serious Adverse Events (SAE)
时间窗: Within the first and final vaccination up until 12 months after the final vaccination
The occurrence of Serious Adverse Events (SAE) in all groups
次要结局
- Cellular immune response(Before the first dose, 14 days after the first dose)
- Changes in laboratory test indicators(4 days after each vaccination)
- Seroconversion rate of SARS-CoV-2 neutralizing antibody(28 days after the final vaccination)
- Seroconversion rate of Covid-19 S protein RBD specific antibody(Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose)
- Incidence of Adverse Events/Reactions (AE/AR)(Within 0-28 days after each vaccination)
- GMT of Covid-19 S protein RBD specific antibody(Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose)
- GMI of Covid-19 S protein RBD specific antibody(Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose)
- GMT of SARS-CoV-2 neutralizing antibody(28 days after the final vaccination)
- GMI of SARS-CoV-2 neutralizing antibody(Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose)
- Incidence of Adverse Events/Reactions (AE/AR)(Within 0-7 days after each vaccination)
- GMT of SARS-CoV-2 neutralizing antibody(Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose)
- Seroconversion rate of SARS-CoV-2 neutralizing antibody(Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose)