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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.
A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant COVID-19 Vaccine (Sf9 Cell) | Experimental | Participants who received 3 doses of Inactivated COVID-19 vaccines with the third dose at least 6 months (≥180 days) prior to enrolment. N=60 Intervention: Recombinant COVID-19 Vaccine (Sf9 Cell) |
|
| Inactivated COVID-19 vaccines | Active Comparator | Participants who received 3 doses of Inactivated COVID-19 vaccines with the third dose at least 6 months (≥180 days) prior to enrolment. N=60 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 Vaccine (Sf9 Cell) | Biological | 1dose, Intramuscular Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions (ADRs) | Day 0-30 post-boost dose. | |
| Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain | Day 30 post-boost dose. | |
| Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant | Day 30 post-boost dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain | Day 30 post-boost dose. | |
| Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant | Day 30 post-boost dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
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| COVID-19 Vaccine (Vero Cell), Inactivated | Biological | 1dose, Intramuscular Injection |
|
| GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain | Day 7, day 14, month 3 and month 6 after the booster dose. |
| GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant | Day 7, day 14, month 3 and month 6 after the booster dose. |
| GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD | Day 7, day 14, day 30, month 3 and month 6 after the booster dose. |
| 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 |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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