This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
180
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Incidence of adverse reactions/events
Time frame: 0-28 days after each dose of vaccination
Serious Adverse Events (SAE)
Time frame: within 12 months post full vaccination
Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function)
Time frame: Day 3 after each dose of vaccination
The seropositive rates of SARS-CoV-2 neutralizing antibody
Time frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
The seropositive level of SARS-CoV-2 neutralizing antibody
Time frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
The seropositive rates of SARS-CoV-2 IgG antibody(tested by ELISA)
Time frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
The seropositive level of SARS-CoV-2 IgG antibody(tested by ELISA)
Time frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
The proportion of IFN-γ positive cells (by ELISpot)
Time frame: Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group)
Level of IL-2、IL-4、IL-5、IL-6、TNFα、IFN-γ (by ELISA)
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Time frame: Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group)