This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults aged 18\~59 Years.
This study is a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged 18\~59 years. The purpose of this study is to evaluate the immunogenicity and safety of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research \& Development Co., Ltd. A total of 744 subjects will be enrolled, with 144 at phase Ⅰ, and 600 at phase Ⅱ. All of participants in phase Ⅰ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28.300 participants in phase Ⅱ will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14 or day 0,28 and one dose of booster immunization will be given 6 months after primary immunization of day 0,14 or day 0,28.The other 300 participants in phase Ⅱ will be assigned to receive three doses of experimental vaccine or placebo on the schedule of day 0,14,42 or 0,28,56 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
744
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Safety indexes of adverse reactions
Incidence of adverse reactions occured from Day 0 to Day 28 after each dose
Time frame: From Day 0 to Day 28 after each dose
Immunogenicity indexes of neutralizing-antibody seroconversion rates
The seroconversion rate of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after the two-dose vaccination.
Time frame: The 14th day /the 28th day after two doses of vaccination
Safety indexes of adverse reactions
Incidence of adverse reactions 7 days after each dose of vaccination
Time frame: 7 days after each dose of vaccination
Safety indexes of Incidence of abnormal laboratory index
Incidence of abnormal laboratory index (blood routine test, blood chemistry test,and urine routine test) on the 3th day after each dose of vaccination in phase Ⅰ
Time frame: On the 3th day after each dose of vaccination in phase Ⅰ
Safety indexes of serious adverse events (SAEs)
Incidence of SAEs from the beginning of the vaccination to 6 months post the whole-schedule vaccination
Time frame: From the beginning of the vaccination to 6 months post the whole-schedule vaccination
Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies
The seropositive rate, GMT, and GMI of neutralizing antibodies 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
Time frame: 14 days (emergency schedule)/28 days (routine schedule) after two-dose vaccination
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Two doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ.
Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ.
Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ
Two doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ.
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
Three doses of placebo at the schedule of day 0,14,42
Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
Three doses of placebo at the schedule of day 0,28,56
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies
The seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies 28 days after the two doses (emergency schedule)
Time frame: 28 days after the two doses (emergency schedule)
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ
Phase Ⅱ:The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the third dose(only for days 0,14,42 and days 0,28,56 schedule)
Time frame: 28 days after the third dose (only for days 0,14,42 and days 0,28,56 schedule)
Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ
Phase Ⅱ:The seropositivity rate, GMT, and GMI 14 day (emergency schedule)/28 days (routine schedule) after the booster dose (only for days 0,14 and days 0,28 schedule)
Time frame: 14 day (emergency schedule)/28 days (routine schedule) after the booster dose (only for days 0,14 and days 0,28 schedule)
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 7/14/21 days after the first dose vaccination (emergency schedule)
Time frame: 7/14/21 days after the first dose vaccination (emergency schedule)
Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ
Phase Ⅰ:The seroconversion rate, seropositive rate, GMT, and GMI 28/35/42 days after the first dose vaccination (routine schedules)
Time frame: 28/35/42 days after the first dose vaccination (routine schedules)
Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies
Phase Ⅰ:The seropositive rate of IgG, IgM antibodies 7/14/21/28/42 days after the first dose vaccination (emergency schedule)
Time frame: 7/14/21/28/42 days after the first dose vaccination (emergency schedule)
Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies
Phase Ⅰ: The seropositive rate of IgG,IgM antibodies 28/35/42/56 days after the first dose vaccination (routine schedule)
Time frame: 28/35/42/56 days after the first dose vaccination (routine schedule)