a safety and immunogenicity study of inactivated sars-cov-2 vaccine (vero cells) in healthy population aged 18 years and above(covid-19)

Conditions: COVID-19

Summary: this study is a randomized, double-blinded, and placebo controlled phase ⅰ clinical trial of the sars-cov-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.


Eligibility criteria:
inclusion criteria: 1. healthy permanent residents aged 18 years and above; 2. subjects agree to sign the informed consent forms voluntarily; 3. subjects are able to comply with the requirements of the clinical trial protocol; 4. armpit temperature \<=37.0 degree c; 5. female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures had been taken within 2 weeks before enrollment. exclusion criteria: 1. within 14 days before vaccination, subjects have been abroad and to villages/communities experienced covid-19 epidemics, and in contact with covid-19 cases or suspected cases. subjects are under isolation observation, or living in the villages/communities with covid-19 cases or suspected cases; 2. confirmed cases, suspected cases or asymptomatic cases with covid-19 (refer to information system of china disease prevention and control); 3. subjects with history of sars virus infection by self-reported; 4. positive in throat swab through rt-pcr; 5. positive in sars-cov-2 antibody test; 6. subjects with abnormal indicators, such as blood biochemistry, blood routine, urine routine and coagulation function which might show clinical meaning, before administration; 7. subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated sars-cov-2 vaccine; 8. subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history; 9. subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 10. subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension (systolic pressure \>=140 mmhg, diastolic pressure \>=90 mmhg; subjects aged \>=60 years with systolic pressure \>=150 mmhg, diastolic pressure \>=100 mmhg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases; 11. subjects diagnosed with congenital or acquired immune deficiency, hiv infection, lymphoma, leukemia or other autoimmune diseases; 12. subjects with history of coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disease); 13. subjects receiving anti-tb treatment; 14. subjects receiving other research drugs within 6 months before vaccination; 15. subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); 16. subjects receiving blood products within 3 months before administration; 17. subjects vaccinated with live attenuated vaccine within 14 days before vaccination; 18. subjects vaccinated with other vaccine within 7 days before vaccination; 19. the researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.