A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases. Subjects in the 2 dose group were injected with 2 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0,1 month immunization program, and subjects in the 3 dose group were injected with 3 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0, 1, 2 month immunization program .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
900
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Hunan Provincial Center for Disease Control and Prevention
Hunan, Changsha, China
Neutralizing antibody positive conversion rate
Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination
Time frame: 30 days after inoculation
Neutralizing antibody GMT, positive rate
GMT and positive rate of neutralizing antibody 14 days after the first dose of pre-vaccination people
Time frame: 14 days after inoculation
Neutralizing antibody GMT, positive conversion rate/positive rate
GMT, positive conversion rate/positive rate of neutralizing antibodies 14 days after full vaccination in the pre-vaccination population
Time frame: 14 days after inoculation
Neutralizing antibody GMT
Neutralizing antibody GMT 30 days after vaccination in pre-negative people
Time frame: 30 days after inoculation
Neutralizing antibody GMT
Neutralizing antibody GMT in the 6th and 12th month after the entire vaccination
Time frame: 6th and 12th month after inoculation
Neutralizing antibody GMI, positive rate
Neutralizing antibody GMI and positive rate at the 6th and 12th month of the entire vaccination
Time frame: 6th and 12th month after inoculation
IL-2, IL-4, IL-5, IL-6 and IFN-γ levels
Levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ on the 4th day and 12 months after the entire vaccination
Time frame: 4th day and 12 months after inoculation
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Adverse events
Adverse events 30 days after the first dose of vaccine to the entire exemption
Time frame: 30 days after inoculation
Serious adverse event
Serious adverse events from day 0 after vaccination to 12 months after the entire immunization
Time frame: 12 months after inoculation