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This study is a randomized, blinded, parallel-controlled phase 3 clinical trial. The study intent to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (LVRNA009) as heterologous booster in participants aged 18 years and older vaccinated 2 doses Inactivated SARS-CoV-2 Vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVRNA009 study group | Experimental |
| |
| CoronaVac® control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVRNA009 | Biological | 50μg /0.5 mL/Vial/person |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) | 14 days after vaccination for all participants | |
| Seroconversion Rate (SCR) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) | Seroconversion is defined as: GMT post vaccination≥ 4-fold rise from baseline GMT value | 14 days after vaccination for all participants |
| Incidence of each solicited (local and systemic) AE and each unsolicited AE | AE within 14 days, unsolicited AE within 28 days after vaccination for all participants | |
| Intensity of each solicited (local and systemic) AE and each unsolicited AE | AE within 14 days, unsolicited AE within 28 days after vaccination for all participants | |
| Duration of each solicited (local and systemic) AE and each unsolicited AE | AE within 14 days, unsolicited AE within 28 days after vaccination for all participants |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean increase (GMI) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) | 14 days after vaccination for all participants | |
| GMT of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) | 28 days, 3 months, 6 months, and 12 months after vaccination for all participants |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular immune subgroup: virus antigen-specific IL-2, IL-4, IL-13, IFN-γ cytokine titers (ELISpot) | 7 days, 14 days, and 28 days after vaccination | |
| Cross-neutralization subgroup: cross-neutralizing ability of VNA (live virus neutralizing assay) against other VOCs of SARS-CoV-2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan Zhang | Contact | 021-33360772 | 8066 | fan.zhang@aimbio.com |
| Wumei Han | Contact | 021-33360772 | 8021 | wumei.han@aimbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Aamer Ikram | National Institute of Health, Islamabad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Unit, National Institute of Health | Islamabad | 45500 | Pakistan |
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| ID | Term |
|---|---|
| C000722715 | LVRNA009 COVID-19 vaccine |
| C000722216 | sinovac COVID-19 vaccine |
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A randomized, blinded, parallel-controlled design
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| CoronaVac® |
| Biological |
0.5 mL/Vial, 0.5mL per human dose containing 600SU of inactivated SARS-CoV-2 antigen |
|
| SCR of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) | 28 days, 3 months, 6 months, and 12 months after vaccination for all participants |
| GMI of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) | 28 days, 3 months, 6 months, and 12 months after vaccination for all participants |
| GMT of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay) | 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants |
| SCR of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay) | 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants |
| GMI of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay) | 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants |
| GMT of S-protein specific IgG antibodies (ELISA) | 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants |
| SCR of S-protein specific IgG antibodies (ELISA) | 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants |
| GMI of S-protein specific IgG antibodies (ELISA) | 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants |
| Incidence of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events | within 12 months after vaccination for all participants |
| Intensity of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events | within 12 months after vaccination for all participants |
| Causality of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events | within 12 months after vaccination for all participants |
| 14 and 28 days after vaccination |