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This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with vaccination course 0, 21, 42 days. 892 subjects aged 18-59 years are recruited and randomly inoculated in a 1:1 ratio from a pilot or commercial batch of Recombinant COVID-19 Vaccine (Sf9 Cell).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot batch | Experimental | Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21,42. |
|
| Commercial batch | Active Comparator | Three doses of Recombinant COVID-19 vaccine (Sf9 cell) at the schedule of day 0, 21,42. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 vaccine (Sf9 cell) | Biological | This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse reactions(ARs). | The incidence of ARs within 7 days after each vaccination. | Day 0 to day 7 |
| Anti-SARS-CoV-2 specific neutralizing antibodies expressed as geometric mean titer (GMT)and seroconversion rate (SCR). | The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third vaccination. | Day 72 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of ARs. | The incidence of ARs from Day 0 to Day 72. | Day 0 to Day 72 |
| The incidence of adverse events (AEs). | The incidence of adverse events (AEs) from Day 0 to Day 72. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for the second/third dose:
In this trial, the second/third vaccination may be stopped in some cases. They include systemic allergic reaction, severe hypersensitivity, or intolerable Grade 3 or above ARs after the previous dose of vaccine. If these reactions occur, the subjects should not continue to receive the second/third vaccination.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Control and Prevention | Huai'an | 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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| Day 0 to Day 72 |
| The incidence of serious adverse events (SAEs). | The incidence of SAEs from day 0 through 6 months after the third vaccination. | Day 0 to 6 months after the third vaccination. |
| The Geometric Mean Fold Increase (GMI) of the anti-SARS-COV-2 specific neutralizing antibody. | The GMI of the anti-SARS-COV-2 specific neutralizing antibody of the subjects on day 30 after the third vaccination. | Day 72 |
| The Geometric Mean Titre (GMT), Seroconversion Rate (SCR) and GMI of anti-SARS-COV-2 S-RBD Immunoglobulin (IgG) antibody | The GMT, SCR and GMI of anti-SARS-COV-2 S-RBD IgG antibody of the subjects on day 30 after the third vaccination | Day 72 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |