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| Name | Class |
|---|---|
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
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This trial is a phase I clinical trial of a SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). The trial used a randomized, blinded, placebo-controlled design to evaluate the safety, tolerability, and preliminary immunogenicity of the trial vaccine in participants Aged 18 Years and Older who had received SARS-CoV-2 Vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) | Experimental | 100 μg /1.0 mL/dose, One booster dose 1.0mL IM injection of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). |
|
| Saline | Placebo Comparator | One booster dose 1.0mL IM injection of saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Bivalent mRNA Vaccine | Biological | 100 μg /1.0 mL/dose, slightly milky white and clear liquid, intramuscular injection into the lateral deltoid muscle of the upper arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of solicited and unsolicited adverse events | Incidence of solicited and unsolicited adverse events 0-28 days after booster vaccination in all participants. | 0-28 days after booster vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of abnormal laboratory-related parameters | Incidence of abnormal laboratory-related parameters on the third day after booster vaccination in participants. | 3 days after booster vaccination |
| Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) |
| Measure | Description | Time Frame |
|---|---|---|
| Specific T cell responses secreting IL-2, IL-4, IL-13, IFN-γ cytokines (ELISpot assay) | Specific T cell responses secreting IL-2, IL-4, IL-13, IFN-γ cytokines (ELISpot assay) on days 7, 14, and 28 after booster vaccination. | 7, 14, 28 days after booster vaccination. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| fan zhang | AIM Vaccine Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital Bengbu | Bengbu | Anhui | China |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Saline | Other | 100 μg /1.0 mL/dose, intramuscular injection into the lateral deltoid muscle of the upper arm. |
|
Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after booster vaccination in all participants. |
| Within 12 months after booster vaccination. |
| GMT, SCR, and GMI of neutralizing antibodies against SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains) | GMT, SCR, and GMI of neutralizing antibodies against SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains) on days 7, 14, and 28 after booster vaccination in participants. | 7, 14, 28 days after booster vaccination. |
| GMT of neutralizing antibodies against SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains) | GMT of neutralizing antibodies against SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains) at months 3, 6, and 12 after booster vaccination in participants. | 3, 6, 12 months after booster vaccination. |
| GMC, SCR, and GMI of IgG antibodies against S proteins of SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains) | GMC, SCR, and GMI of IgG antibodies against S proteins of SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains) on days 7, 14, and 28 after booster vaccination. | 7, 14, 28 days after booster vaccination. |
| GMC of IgG antibodies against S proteins of SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains) | GMC of IgG antibodies against S proteins of SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains) at 3, 6, and 12 months after booster vaccination. | 3, 6, 12 months after booster vaccination. |
| D017670 |
| Sodium Compounds |