COVID-19
Conditions
Keywords
COVID-19
Brief summary
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.
Interventions
BIOLOGICALlow-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
BIOLOGICALhigh-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)
Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
BIOLOGICALplacebo
Intramuscular injection of placebo in the deltoid muscle of the upper arm
Sponsors
Lanzhou Institute of Biological Products Co., Ltd
Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd.
Zhengzhou University
National Vaccine and Serum Institute, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age range: healthy people aged 3 years and and older who can provide legal identification; * The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol; * Inquired about medical history and physical examination, the investigator judged that the health condition is good; * No history of SARS-CoV-2 vaccination before enrollment; * Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment; * During the entire study follow-up period, be able and willing to complete the entire prescribed study plan.
Exclusion criteria
First Dose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody (wild Strains) on the 15th day after the full course of vaccination | 15th day after the full course of vaccination | Phase 2 |
| the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination | through 7 days after each dose | Phase 1 |
| the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination | through 30 days after each dose | Phase 1 |
| the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination | through 30 days after each dose | Phase 1 |
| the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination | up to 12 months after the full course of vaccination | Phase 1 |
| the incidence of AESI from the first dose of vaccination to 12 months after the full course of vaccination | up to 12 months after the full course of vaccination | Phase 1 |
| Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody(wild Strains) on the 15th day after the full course of vaccination | 15th day after the full course of vaccination | Phase 1 |
| the incidence and severity of non-collective adverse reactions/events within 40 days after each dose of vaccination | through 40 days after each dose | Phase 2 |
| the incidence and severity of non-collective adverse reactions/events within 60 days after each dose of vaccination | through 60 days after each dose | Phase 2 |
| the incidence and severity of adverse events leading to withdrawal within 40 days after each dose of vaccination | through 40 days after each dose | Phase 2 |
| the incidence and severity of adverse events leading to withdrawal within 60 days after each dose of vaccination | through 60 days after each dose | Phase 2 |
| the incidence of AESI from the the first dose of vaccination to 12 months after the full course of vaccination | up to 12 months after the full course of vaccination | Phase 2 |
| the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination | through 30 minutes after each dose | Phase 1 |
| the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine on the 4th day after each dose of vaccination | 4th day each dose | Phase 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | before each dose , the 15th day after the second dose, the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 1 |
| 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 | before each dose，the 15th, 30th day after the full course of vaccination | Phase 1 |
| 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 | 30th day after the full course of vaccination | Phase 2 |
| 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 | before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 2 |
| Two-dose group: Seroconversion before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 2 |
| Two-dose group: Binding Antibody (IgG) before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | before each dose，the 15th, 30th, 90th, 180th, 360th day after the full course of vaccination | Phase 2 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | before each dose, 15th, 30th day after the full course of vaccination | Phase 2 |
| 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) | 30th day after the full course of vaccination | Phase 1 |
Countries
China
Outcome results
None listed