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This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety and preliminary immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese healthy adults aged 60 years and over.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine group 1 | Experimental | 20μg dose of SYS6006 vaccine IM, on day 0 and day 21. |
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| Vaccine group 2 | Experimental | 30μg dose of SYS6006 vaccine IM, on day 0 and day 21. |
|
| Placebo | Placebo Comparator | placebo IM, on day 0 and day 21 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 μg dose of SYS6006 | Biological | 20 μg dose of SYS6006 vaccine IM on day 0 and day 21. |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events, including solicited and unsolicited events | From the first dose through 30 days following the second dose. | |
| adverse events associated with the study intervention | From the first dose through 30 days following the second dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of anti-SARS-CoV-2 antibody (specific IgG antibody and neutralizing antibody ) | 14 days after the first dose; 7 days, 14 days, 30 days, 90 days, 180 days and 360 days after the second dose | |
| Serious adverse events (SAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lanjuan Li | Shulan (Hangzhou) Hospital | Principal Investigator |
| Guiling Chen | Shulan (Hangzhou) Hospital | Principal Investigator |
| Xiang Lu | Sir Run Run Hosipital Nanjing Medical University | Principal Investigator |
| Yuwen Su | Sir Run Run Hosipital Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Hospital Nanjing Medical University | Nanjing | Jiangsu | China | |||
| Shulan(hangzhou) Hospital |
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| 30 μg dose of SYS6006 | Biological | 30 μg dose of SYS6006 vaccine IM on day 0 and day 21. |
|
| Placebo | Drug | Placebo IM on day 0 and day 21. |
|
| from the first dose through 12 months after the second dose. |
| Adverse events of special interest (AESI) | from the first dose through 12 months after the second dose. |
| Laboratory test related adverse events | 4 days following each dose. |
| Hangzhou |
| Zhejiang |
| China |