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| Name | Class |
|---|---|
| Lanzhou Institute of Biological Products Co., Ltd | INDUSTRY |
| Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd. | UNKNOWN |
| Zhengzhou University | OTHER |
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phase I study will evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 3 years and older. 300 subjects will be enrolled and divided into 5 age groups: 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group and 3-8 years old group. In each group, there are two regimen cohort: low-dose at 0,30, 60 schedule and high-dose at 0,30,60 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1.
Phase II clinical study will explore dose and immunization procedures in 5 age groups, including 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group, and 3-8 years old group, with a total of 3280 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 low-dose group | Experimental |
| |
| Phase 1 high-dose group | Experimental |
| |
| Phase 1 placebo group | Placebo Comparator |
| |
| Phase 2 low-dose group A | Experimental |
| |
| Phase 2 low-dose group B | Experimental |
| |
| Phase 2 low-dose group C | Experimental |
| |
| Phase 2 low-dose group D | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) | Biological | Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination | Phase 1 | through 30 minutes after each dose |
| the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine on the 4th day after each dose of vaccination | Phase 1 | 4th day each dose |
| the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination | Phase 1 | through 7 days after each dose |
| the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination | Phase 1 | through 30 days after each dose |
| the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination | Phase 1 | through 30 days after each dose |
| the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination | Phase 1 | up to 12 months after the full course of vaccination |
| the incidence of AESI from the first dose of vaccination to 12 months after the full course of vaccination | Phase 1 | up to 12 months after the full course of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Live SARS-CoV-2 neutralization assay) On the 30th day after the full course of vaccination, the neutralizing antibody level (wild Strains) | Phase 1 | 30th day after the full course of vaccination |
| Seroconversion and Geometric Mean Titer (GMT) of SARS-CoV-2-Specific Binding Antibody (IgG) Before each dose, the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after full course of vaccination |
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Inclusion Criteria:
Exclusion Criteria:
First Dose Exclusion Criteria:
Exclusion criteria for the second and third doses of vaccination
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ning ling Center for Disease Control and Prevention | Shangqiu | Henan | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Phase 2 high-dose group A | Experimental |
|
| Phase 2 high-dose group B | Experimental |
|
| Phase 2 high-dose group C | Experimental |
|
| Phase 2 high-dose group D | Experimental |
|
| Phase 2 placebo group A | Placebo Comparator |
|
| Phase 2 placebo group B | Placebo Comparator |
|
| Phase 2 placebo group C | Placebo Comparator |
|
| Phase 2 placebo group D | Placebo Comparator |
|
| high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) | Biological | Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm |
|
| placebo | Biological | Intramuscular injection of placebo in the deltoid muscle of the upper arm |
|
| Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody(wild Strains) on the 15th day after the full course of vaccination | Phase 1 | 15th day after the full course of vaccination |
| the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination | Phase 2 | through 30 minutes after each dose |
| the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination | Phase 2 | through 7 days after each dose |
| the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination | Phase 2 | through 30 days after each dose |
| the incidence and severity of non-collective adverse reactions/events within 40 days after each dose of vaccination | Phase 2 | through 40 days after each dose |
| the incidence and severity of non-collective adverse reactions/events within 60 days after each dose of vaccination | Phase 2 | through 60 days after each dose |
| the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination | Phase 2 | through 30 days after each dose |
| the incidence and severity of adverse events leading to withdrawal within 40 days after each dose of vaccination | Phase 2 | through 40 days after each dose |
| the incidence and severity of adverse events leading to withdrawal within 60 days after each dose of vaccination | Phase 2 | through 60 days after each dose |
| the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination | Phase 2 | up to 12 months after the full course of vaccination |
| the incidence of AESI from the the first dose of vaccination to 12 months after the full course of vaccination | Phase 2 | up to 12 months after the full course of vaccination |
| Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody (wild Strains) on the 15th day after the full course of vaccination | Phase 2 | 15th day after the full course of vaccination |
Phase 1 |
| before each dose , the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination |
| Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Pseudovirus neutralization assay) in the 18-59 years old group before each dose and on the 15th and 30th day after the full course of vaccination | Phase 1 | before each dose,the 15th, 30th day after the full course of vaccination |
| Geometric Mean Titer (GMT) of SARS-COV-2 specific neutralizing antibody (live SARS-CoV-2 neutralization assay)) On the 30th day after the full course of vaccination | Phase 2 | 30th day after the full course of vaccination |
| Two-dose group: the neutralizing antibody levels (live SARS-CoV-2 neutralization assay) before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 2 | before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination |
| Two-dose group: Seroconversion before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 2 | before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination |
| Two-dose group: Binding Antibody (IgG) before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 2 | before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination |
| Three-dose group: the neutralizing antibody levels (live SARS-CoV-2 neutralization assay) before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 2 | before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination |
| Three-dose group:Seroconversion before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 2 | before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination |
| Three-dose group:Binding Antibody (IgG) before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 2 | before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination |
| Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Pseudovirus neutralization assay) in the 18-59 years old 0,30,60 group before each dose , the 15th and 30th day after the full course of vaccination | Phase 2 | before each dose, 15th, 30th day after the full course of vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |