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The phase I/II study is to evaluate the safety and immunogenicity of SARS-COV-2 mRNA Vaccine (RBMRNA-176) at different doses in healthy subjects aged 18 years and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants aged 18 to 59 years. | Experimental | Escalating dose levels |
|
| Participants aged 60 years and older. | Experimental | Escalating dose levels |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBMRNA-176 | Biological | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited local and systemic adverse reactions (AR) | For phase I | Within 14 days after each dose |
| All Adverse Events (AE) related to injection | For phase I | From the first dose to within 28 days after the whole schedule injection |
| The level of neutralizing antibody against SARS-CoV-2 | For phase II | The 28th day after the whole schedule injection |
| Measure | Description | Time Frame |
|---|---|---|
| Unsolicited Adverse Events (AE) | For phase I & II | After the first dose till before the second dose, and within 28 days after the second dose |
| All serious adverse events (SAE) | For phase I & II |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Xinhua Hospital affiliated to North Sichuan Medical College | Chengdu | Sichuan | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 22, 2025 | |
| Reset | Oct 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 22, 2025 | Oct 10, 2025 |
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| Placebo | Other | 0.9% sodium chloride (normal saline) injection |
|
| Within 21 days after the first dose, and within 28 days after the second dose, and 90days, 180 days, 360 days after the whole schedule injection |
| The level of Immunoglobulin G (IgG) antibody against SARS-CoV-2 S protein | For phase I & II | The 21st day after the first dose, and the 7th day, 28th day, 90th day, 180th day, 360th day after the whole schedule injection |
| The level of neutralizing antibody against SARS-CoV-2 | For phase I | The 21st day after the first dose, and the 7th day, 28th day, 90th day, 180th day, 360th day after the whole schedule injection |
| The level of neutralizing antibody against SARS-CoV-2 | For phase II | The 21st day after the first dose, and the 7th day, 90th day, 180th day, 360th day after the whole schedule injection |
| Solicited local and systemic ARs | For phase II | Within 14 days after each dose |
| All AEs related to injection | For phase II | From the first dose to within 28 days after the whole schedule injection |