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| Name | Class |
|---|---|
| Shenzhen Kangtai Biological Products Co., LTD | INDUSTRY |
| Jiangsu Province Centers for Disease Control and Prevention | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medium dosage on day 0, 14(18~59 years) | Experimental | Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14 |
|
| high dosage on day 0, 14(18~59 years) | Experimental | Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14 |
|
| placebo on day 0, 14(18~59years) | Placebo Comparator | Two doses of placebo on the schedule of day 0,14 |
|
| medium dosage on day 0, 28, 56(18~59 years) | Experimental | Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 |
|
| high dosage on day 0, 28, 56(18~59 years) | Experimental | Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medium dosage inactivated SARS-CoV-2 vaccine | Biological | medium dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions/events | 0-28 days after each dose of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events (SAE) | within 12 months post full vaccination | |
| 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 |
| Measure | Description | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu | 210000 | China |
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| placebo on day 0, 28, 56(18~59 years) | Placebo Comparator | Three doses of placebo on the schedule of day 0,28,56 |
|
| medium dosage on day 0, 28, 56(>59 years) | Experimental | Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 |
|
| high dosage on day 0, 28, 56(>59 years) | Experimental | Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 |
|
| placebo on day 0, 28, 56(>59 years) | Placebo Comparator | Three doses of placebo on the schedule of day 0,28,56 |
|
| high dosage inactivated SARS-CoV-2 vaccine | Biological | high dosage |
|
| Placebo | Biological | placebo |
|
| 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 |
| 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 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) |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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