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Subjects aged 18 and above who have been completed primary or booster vaccination of COVID-19 inactivated vaccines for 3 months or more, to conduct a randomized, parallel controlled, double-blind, single-center phase I clinical trial of Recombinant variant COVID-19 vaccine (Sf9 cell)(WSK-V102) to evaluate the safety, tolerance and immunogenicity of this vaccine in the study population.
Low and high doses of study vaccine were compared with control groups to evaluate the safety and immunogenicity of the study vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Experimental | low dose and high dose, only one dose at day 0 |
|
| control group | Active Comparator | one dose at day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 variant vaccine(Sf9 cell) | Biological | IM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| solicited adverse events (AE) | Incidence of solicited adverse events (AE) | 0-14 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| laboratory safety | Changes in laboratory tests on day 3 after vaccination | 3 days after vaccination |
| safety outcome | Incidence of unsolicited adverse events (AE) and serious adverse events (SAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Control | Taizhou | 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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| Recombinant COVID-19 vaccine(CHO cell) |
| Biological |
IM |
|
| 30 days after vaccination,12 months after vaccination |
| binding antibodies | Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of S-RBD protein-specific antibodies (ELISA) against SARS-CoV-2 | 14 days, 30 days, 3 months and 6 months |
| neutralizing antibodies | Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of neutralizing antibodies against SARS-CoV-2 prototype strain and Omicron variant strain (according to the prevailing strain) | 14 days, 30 days, 3 months and 6 months |
| cellular immune | ELISpot was used to detect the cell frequencies of IFN-γ and IL-2 secreted by SARS-CoV-2 S-RBD protein | 14 days and 3 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |