Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults

Inclusion criteria

• healthy participants aged 18 years and above who have not received COVID-19 vaccine.
• The subjects can provide with informed consent and sign informed consent form (ICF).

• The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study.

• Axillary temperature ≤ 37.0℃. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not been to medium or high risk areas in the past 21 days and have no history of departure.

• be determined to be healthy by medical history, physical examination and clinical examination and meet the requirements for immunization of this product.

Exclusion criteria

• Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
• Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination.
• Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study.
• Suffering from acute febrile disease, infectious disease, or SARS infection history
• Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, which cannot be controlled by medication (systolic blood pressure ≥180mmHg, diastolic blood pressure ≥110mmHg)
• Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines), Such as diabetes, thyroid disease and so on.
• Congenital or acquired angioedema / neuroedema.
• had urticaria one year before this vaccination.
• Asplenia or functional asplenia.
• Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection).
• Faintng during acupuncture treatment
• Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day)
• Received blood products within 4 months before vaccination.
• Received other investigational drugs within 1 month prior to receiving the investigational vaccines.
• Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines.
• Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine.
• Be receiving anti-tuberculosis treatment
• Have the history of SARS-CoV-2 infection or COVID-19
• Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent