Phase I/II Clinical Trial of Recombinant Novel Coronavirus (COVID-19) Vaccine (Adenovirus Type 5 Vector) for Inhalation
COVID-19
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Vaccine, Ad5, Safety, Immunogenicity, SARS-CoV-2, Adenovirus Vector, Aerogen Solo
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Jiangsu Provincal Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Arm 22
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
A1a Phase I low 2 doses
A1b Phase I placebo low 2 doses
A2a Phase I medium 2 doses
A2b Phase I placebo medium 2 doses
A3a Phase I high 2 doses
A3b Phase I placebo high 2 doses
A4a Phase I combine 2 doses
A4b Phase I placebo combine 2 doses
A5a Phase I single dose
A5b Phase I placebo single dose
B1a Phase II low 2 doses
B1b Phase II placebo low 2 doses (18-59)
B2a Phase II medium 2 doses
B2b Phase II placebo medium 2 doses
B3a Phase II high 2 doses
B3b Phase II placebo high 2 doses
B4a Phase II combine 2 doses
B4b Phase II placebo combine 2 doses
B5a Phase II intramuscular single dose
B5b Phase II placebo intramuscular single dose
B6a Phase II Aerogen Solo single dose
B6b Phase II placebo Aerogen Solo single dose
Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart
6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo
Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart
Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection
placebo containing 0 vp, 1 dose Intramuscular Injection
Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
placebo containing 0 vp, 1 dose Aerogen Solo