phase I study will evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 3 years and older. 300 subjects will be enrolled and divided into 5 age groups: 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group and 3-8 years old group. In each group, there are two regimen cohort: low-dose at 0,30, 60 schedule and high-dose at 0,30,60 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1. Phase II clinical study will explore dose and immunization procedures in 5 age groups, including 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group, and 3-8 years old group, with a total of 3280 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,100
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
Intramuscular injection of placebo in the deltoid muscle of the upper arm
Ning ling Center for Disease Control and Prevention
Shangqiu, Henan, China
the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Phase 1
Time frame: through 30 minutes after each dose
the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine on the 4th day after each dose of vaccination
Phase 1
Time frame: 4th day each dose
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Phase 1
Time frame: through 7 days after each dose
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
Phase 1
Time frame: through 30 days after each dose
the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination
Phase 1
Time frame: through 30 days after each dose
the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination
Phase 1
Time frame: up to 12 months after the full course of vaccination
the incidence of AESI from the first dose of vaccination to 12 months after the full course of vaccination
Phase 1
Time frame: up to 12 months after the full course of vaccination
Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody(wild Strains) on the 15th day after the full course of vaccination
Phase 1
Time frame: 15th day after the full course of vaccination
the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Phase 2
Time frame: through 30 minutes after each dose
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Phase 2
Time frame: through 7 days after each dose
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
Phase 2
Time frame: through 30 days after each dose
the incidence and severity of non-collective adverse reactions/events within 40 days after each dose of vaccination
Phase 2
Time frame: through 40 days after each dose
the incidence and severity of non-collective adverse reactions/events within 60 days after each dose of vaccination
Phase 2
Time frame: through 60 days after each dose
the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination
Phase 2
Time frame: through 30 days after each dose
the incidence and severity of adverse events leading to withdrawal within 40 days after each dose of vaccination
Phase 2
Time frame: through 40 days after each dose
the incidence and severity of adverse events leading to withdrawal within 60 days after each dose of vaccination
Phase 2
Time frame: through 60 days after each dose
the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination
Phase 2
Time frame: up to 12 months after the full course of vaccination
the incidence of AESI from the the first dose of vaccination to 12 months after the full course of vaccination
Phase 2
Time frame: up to 12 months after the full course of vaccination
Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody (wild Strains) on the 15th day after the full course of vaccination
Phase 2
Time frame: 15th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Live SARS-CoV-2 neutralization assay) On the 30th day after the full course of vaccination, the neutralizing antibody level (wild Strains)
Phase 1
Time frame: 30th day after the full course of vaccination
Seroconversion and Geometric Mean Titer (GMT) of SARS-CoV-2-Specific Binding Antibody (IgG) Before each dose, the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after full course of vaccination
Phase 1
Time frame: before each dose , the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Pseudovirus neutralization assay) in the 18-59 years old group before each dose and on the 15th and 30th day after the full course of vaccination
Phase 1
Time frame: before each dose,the 15th, 30th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-COV-2 specific neutralizing antibody (live SARS-CoV-2 neutralization assay)) On the 30th day after the full course of vaccination
Phase 2
Time frame: 30th day after the full course of vaccination
Two-dose group: the neutralizing antibody levels (live SARS-CoV-2 neutralization assay) before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Time frame: before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Two-dose group: Seroconversion before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Time frame: before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Two-dose group: Binding Antibody (IgG) before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
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Phase 2
Time frame: before each dose,the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Three-dose group: the neutralizing antibody levels (live SARS-CoV-2 neutralization assay) before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Time frame: before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Three-dose group:Seroconversion before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Time frame: before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Three-dose group:Binding Antibody (IgG) before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Phase 2
Time frame: before each dose,the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (Pseudovirus neutralization assay) in the 18-59 years old 0,30,60 group before each dose , the 15th and 30th day after the full course of vaccination
Phase 2
Time frame: before each dose, 15th, 30th day after the full course of vaccination