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.
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 Hospital 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.