This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety, tolerability, immunogenicity and immune persistence of SYS6006 (SARS-CoV-2 mRNA Vaccine) in 18-59 year old healthy population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
40
20 μg dose of SYS6006 vaccine IM on day 0 and day 21.
30 μg dose of SYS6006 vaccine IM on day 0 and day 21.
Placebo IM on day 0 and day 21.
Sir Run Run Hosipital Nanjing Medical University
Nanjing, Jiangsu, China
Shulan(hangzhou) Hospital
Hangzhou, Zhejiang, China
Adverse events, including solicited and unsolicited events
Time frame: From the first dose through 30 days following the second dose.
adverse events associated with the study intervention
Time frame: From the first dose through 30 days following the second dose.
Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of anti-SARS-CoV-2 antibody (specific IgG antibody and neutralizing antibody)
Time frame: 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)
Time frame: from the first dose through 12 months after the second dose.
Adverse events of special interest (AESI)
Time frame: from the first dose through 12 months after the second dose.
Laboratory test related adverse events
Time frame: 4 days following each dose
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