phase I study will evaluate the safety and tolerability of GEN2-Recombinant COVID-19 Vaccine (CHO cells) in healthy people aged 18 years and older. A total of 234 subjects were enrolled, of which 126 were enrolled in the 18-59-year-old group, and were randomly assigned to receive experimental vaccine 1, experimental vaccine 2, experimental vaccine 3 and placebo in a ratio of 2:2:2:1; 60- A total of 54 people were enrolled in the 69-year-old and ≥70-year-old groups, and were randomly assigned to receive the experimental vaccine 1 and placebo according to the ratio of 2:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
234
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells,NVSI-06-08) in the deltoid muscle of the upper arm
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells,NVSI-06-08) in the deltoid muscle of the upper arm
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells,NVSI-06-08) in the deltoid muscle of the upper arm
Intramuscular injection of low-dose Recombinant placebo in the deltoid muscle of the upper arm
Ning ling Center for Disease Control and Prevention
Shangqiu, Henan, China
The incidence rate of any adverse reactions/events
Time frame: within 30 minutes after vaccination
The incidence severity of any adverse reactions/events
Time frame: within 30 minutes after vaccination
the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine
Time frame: on the 4th day after each dose of vaccination
The incidence rate of solicited adverse reactions/events
Time frame: within 0-7 days after vaccination
The incidence severity of solicited adverse reactions/events
Time frame: within 0-7 days after vaccination
The incidence rate of solicited adverse reactions/events
Time frame: within 8-30 days after vaccination
The incidence severity of solicited adverse reactions/events
Time frame: within 8-30 days after vaccination
Incidence of adverse events leading to withdrawal
Time frame: within 8-30 days after vaccination
Severity of adverse events leading to withdrawal
Time frame: within 8-30 days after vaccination
The incidence of SAE observed
Time frame: up to 12 months after full course of immunization
The incidence of AESI observed
Time frame: up to 12 months after full course of immunization
Neutralizing antibody level against SARS-CoV-2 GMT
Time frame: Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization
Neutralizing antibody level against SARS-CoV-2 IgG antibody GMC
Time frame: Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization
Neutralizing antibody level against SARS-CoV-2 positive rate
Time frame: Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization
Neutralizing antibody level against SARS-CoV-2 Positive conversion rate
Time frame: Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization
GMT of GEN2-Recombinant COVID-19 Vaccine (CHO cells, NVSI-06-08) against VOC in healthy people aged 18 and above
Time frame: after the full course of immunization
Cellular immune response level of subjects aged 18-59
Time frame: Before the first vaccination , 15 days after the full course of immunization
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