• Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days
• History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days
• Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days
• Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days
• Self-reported history of SARS
• Self-reported history of new coronavirus infection
• Positive in serum antibodies (IgG or IgM) screening of COVID-19
• Positive in nasopharyngeal swabs or anal swabs through RT-PCR
• Women who are breastfeeding, pregnant or planning to become pregnant during the study period
• BMI≥35 kg/m2
• History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
• Autoimmune disease or immunodeficiency / immunosuppression
• Suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness
• Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months
• Abnormal laboratory test results in the physical examination such as clinically significant abnormal hematology and biochemistry beyond the reference value range (only applicable to Phase I clinical trials)
• History of alcohol or drug abuse
• Receipt of blood products within in the past 3 months
• Receipt of other investigational drugs in the past 30 days
• Receipt of attenuated live vaccines in the past 14 days
• Receipt of inactivated or subunit vaccines in the past 7 days
• Attacks of acute diseases or chronic diseases in the past 7 days
• Axillary temperature >37.0°C
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Unclear, once the trial is complete
Data accessibility: The results of this study are preliminary and the study is ongoing. Access to patient-level data with qualified external researchers may be available upon request once the trial is complete. Corresponding authors: Fengcai Zhu, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210000, China, Email: jszfc@vip.sina.com; Hongjie Yu, School of Public Health, Fudan University, Key Laboratory of Public Health Safety, Ministry of Education, Shanghai 200032, China, E-mail: yhj@fudan.edu.cn; Weidong Yin, Sinovac Biotech Co., Ltd., Beijing 100085, China, Email: yinwd@sinovac.com