Phase I/II Clinical Trial of Recombinant Novel Coronavirus (COVID-19) Vaccine (Adenovirus Type 5 Vector) for Inhalation

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;