This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.
Biological: medium dosage inactivated SARS-CoV-2 vaccine
medium dosage
Biological: high dosage inactivated SARS-CoV-2 vaccine
high dosage
Biological: Placebo
placebo
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 degrees 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 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;
7. Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or
family history;
8. Subjects with congenital malformations or developmental disorders, genetic defects,
severe malnutrition, etc.;
9. 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;
10. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection,
lymphoma, leukemia or other autoimmune diseases;
11. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency,
coagulation disease);
12. Subjects receiving anti-TB treatment;
13. Subjects receiving other research drugs within 6 months before vaccination;
14. Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently
oral or infusion for more than 14 days);
15. Subjects receiving blood products within 3 months before administration;
16. Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
17. Subjects vaccinated with other vaccine within 7 days before vaccination;
18. The researchers shall judge the other conditions which might be not in compliance with
the requirements of this clinical trial.
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China