• Laboratory abnormalities of clinical significance, including white blood cell count, lymphocyte count, neutrophils, platelets, hemoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, fasting blood glucose, and creatinine. Only apply to the sentinel participants in each cohort (the first 30 subjects)
• Family history of seizure, epilepsy, brain or mental disease
• Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past
• Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
• Any acute fever disease or infections
• History of SARS
• Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease
• Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
• Hereditary angioneurotic edema or acquired angioneurotic edema Urticaria in last one year
• No spleen or functional spleen
• Platelet disorder or other bleeding disorder may cause injection contraindication
• Faint at the sight of needles
• Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment within last 6 months
• Prior administration of blood products within last 4 months
• Prior administration of other research medicines within last 1 month
• Prior administration of attenuated vaccine within last 1 month
• Prior administration of inactivated vaccine within last 14 days
• Current anti-tuberculosis prophylaxis or therapy
• Various medical, psychological, social or other conditions which could affect the subjects to sign informed consent according to the judgement of investigator.

Protocol

NR

Statistical plan

*

Data-sharing stated: No
Data accessibility: Corresponding author: Wei Chen, cw0226@foxmail.com