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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 8 research group, including two immunization procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 960 in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose vaccine (18-59 years) & Two dose regimen | Experimental | two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. |
|
| Low-dose vaccine (18-59 years) & Three dose regimen | Experimental | three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. |
|
| High-dose vaccine (18-59 years) & Two dose regimen | Experimental | two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. |
|
| High-dose vaccine (18-59 years) & Three dose regimen | Experimental | three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. |
|
| Low-dose vaccine (60-85 years) & Two dose regimen | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen | Biological | 18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean (GMT) of specific antibody | Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA) | 1 months after immunization in each study group |
| The incidence of adverse reaction (AR) | The incidence of adverse reaction (AR) | 0 to 7 days after vaccination in each study group |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AE) | The incidence of adverse events (AE) | 0 to 28 days after vaccination in each study group |
| The incidence of severe adverse events (SAE) | The incidence of severe adverse events (SAE) |
| Measure | Description | Time Frame |
|---|---|---|
| The consistency analysis of the specific antibody and the specific neutralizing antibody | The consistency analysis of the specific antibody (ELISA) and the specific neutralizing antibody (euvirus and pseudovirus neutralization assays) against SARS-CoV-2 S-RBD protein | 1 months after immunization in each study group |
Inclusion Criteria:
Exclusion Criteria:
First dose exclusion criteria:
Exclusion criteria for subsequent doses:
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| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu, Doctor | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu | 210009 | China |
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two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
|
| Low-dose vaccine (60-85 years) & Three dose regimen | Experimental | three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. |
|
| High-dose vaccine (60-85 years) & Two dose regimen | Experimental | two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. |
|
| High-dose vaccine (60-85 years) & Three dose regimen | Experimental | three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. |
|
| Low-dose placebo (18-59 years) & Two dose regimen | Placebo Comparator | two doses of placebo at the schedule of day 0, 21. |
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| Low-dose placebo (18-59 years) & Three dose regimen | Placebo Comparator | three doses of placebo at the schedule of day 0, 14, 28. |
|
| High-dose placebo (18-59 years) & Two dose regimen | Placebo Comparator | two doses of placebo at the schedule of day 0, 21. |
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| High-dose placebo (18-59 years) & Three dose regimen | Placebo Comparator | three doses of placebo at the schedule of day 0, 14, 28. |
|
| Low-dose placebo (60-85 years) & Two dose regimen | Placebo Comparator | two doses of placebo at the schedule of day 0, 21. |
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| Low-dose placebo (60-85 years) & Three dose regimen | Placebo Comparator | three doses of placebo at the schedule of day 0, 14, 28. |
|
| High-dose placebo (60-85 years) & Two dose regimen | Placebo Comparator | two doses of placebo at the schedule of day 0, 21. |
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| High-dose placebo (60-85 years) & Three dose regimen | Placebo Comparator | three doses of placebo at the schedule of day 0, 14, 28. |
|
| Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen | Biological | 18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. |
|
| High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen | Biological | 18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. |
|
| High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen | Biological | 18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. |
|
| Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen | Biological | 60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. |
|
| Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen | Biological | 60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. |
|
| High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen | Biological | 60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. |
|
| High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen | Biological | 60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. |
|
| Low-dose placebo (18-59 years) & Two dose regimen | Biological | 18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21. |
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| Low-dose placebo (18-59 years) & Three dose regimen | Biological | 18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28. |
|
| High-dose placebo (18-59 years) & Two dose regimen | Biological | 18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21. |
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| High-dose placebo (18-59 years) & Three dose regimen | Biological | 18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28. |
|
| Low-dose placebo (60-85 years) & Two dose regimen | Biological | 60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21. |
|
| Low-dose placebo (60-85 years) & Three dose regimen | Biological | 60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28. |
|
| High-dose placebo (60-85 years) & Two dose regimen | Biological | 60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21. |
|
| High-dose placebo (60-85 years) & Three dose regimen | Biological | 60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28. |
|
| 0 to 28 days after vaccination in each study group |
| The incidence of serious adverse events | The incidence of serious adverse events | 6 months after vaccination in each study group |
| Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies | Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays) | 1 months after immunization in each study group |
| The positive conversion rate of S-RBD protein-specific antibody | The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2 | 14 days, 30 days after immunization in each study group |
| Geometric mean fold increase (GMI) of S-RBD protein-specific antibody | Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2 | 14 days, 30 days after immunization in each study group |
| Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies | Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays) | 14 days after immunization in each study group |
| The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody | The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test) | 14 days, 30 days after immunization in each study group |
| Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies | Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays) | 14 days, 30 days after immunization in each study group |
| The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody |
The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups |
| 1 months after immunization in each study group |
| The persistence (GMT，GMI，positive conversion rate) of specific antibodies | The persistence (GMT，GMI，positive conversion rate) of specific antibodies against SARS-CoV-2 S-RBD protein | 6 months after vaccination in each study group |
| Subtypes of immunoglobulin G (IgG) antibodies | Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group | 1 months after immunization in each study 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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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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