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Sponsor decided to cancel this trial.
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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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This is a phase Ⅱb, 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 18-59 and 60-85 years) with immunization procedures 0, 21, 42 days and doses 40μg.
This is a phase â…¡b, 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 18-59 and 60-85 years) . The phase â…¡b clinical trials designed two research group, including adults group (aged 18-59 years) and elderly adults group (aged 60-85 years). Each group including 2000 participants. Vaccination or placebo group will be randomly assigned to receive in a 3:1 ratio, 4000 in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adults group (aged 18-59 years) & vaccine | Experimental | three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42. |
|
| adults group (aged 18-59 years) & placebo | Placebo Comparator | three doses of placebo at the schedule of day 0, 21, 42. |
|
| elderly adults group (aged 60-85 years) & vaccine | Experimental | three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42. |
|
| elderly adults group (aged 60-85 years) & placebo | Placebo Comparator | three doses of placebo at the schedule of day 0, 21, 42. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 vaccine (Sf9 cells) | Biological | Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse reaction (AR) | The incidence of adverse reaction (AR) | 0 to 7 days after each dose |
| The incidence of Adverse Events of Special Interest (AESI) | The incidence of Adverse Events of Special Interest (AESI) | from day 0 to day 60 after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AE) | The incidence of adverse events (AE) | from day 0 to day 30 after last dose |
| The incidence of grade 3 adverse events (AE) | The incidence of grade 3 adverse events (AE) |
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Inclusion Criteria:
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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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo | Biological | Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42. |
|
| from day 0 to day 30 after last dose |
| The incidence of severe adverse events (SAE) | The incidence of severe adverse events (SAE) | Month 12 after the whole process of vaccination |
| Geometric mean (GMT) of specific antibody | Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA) in immunogenicity subgroup. | day 30, day 60, month 6, month 12 after last dose |
| 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) | day 30, day 60, month 6, month 12 after last dose |
| 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 | day 30, day 60, month 6, month 12 after last dose |
| 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 | day 30, day 60, month 6, month 12 after last dose |
| 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) | day 30, day 60, month 6, month 12 after last dose |
| 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) | day 30, day 60, month 6, month 12 after last dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |