COVID-19
Conditions
Brief 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.
Interventions
medium dosage
high dosage
BIOLOGICALPlacebo
placebo
Sponsors
Shenzhen Kangtai Biological Products Co., LTD
Jiangsu Province Centers for Disease Control and Prevention
Beijing Minhai Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions/events | 0-28 days after each dose of vaccination |
Secondary
| Measure | Time frame |
|---|---|
| The seropositive level of SARS-CoV-2 neutralizing antibody | Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination |
| The seropositive rates of SARS-CoV-2 IgG antibody(tested by ELISA) | Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination |
| The seropositive rates of SARS-CoV-2 neutralizing antibody | Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination |
| Serious Adverse Events (SAE) | within 12 months post full vaccination |
| The seropositive level of SARS-CoV-2 IgG antibody(tested by ELISA) | Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination |
| The proportion of IFN-γ positive cells (by ELISpot) | Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group） |
| Level of IL-2、IL-4、IL-5、IL-6、TNFα、IFN-γ (by ELISA) | Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group） |
| Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function) | Day 3 after each dose of vaccination |
Other
| Measure | Time frame |
|---|---|
| The SARS-CoV-2 antibody level of IgG1, IgG2, IgG3, IgG4 and Nucleoprotein | Day 14 and 28 after each dose, and 3, 6, 12 months post full vaccination(18~59years) |
Countries
China
Outcome results
None listed