This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are \>59 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.
This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. Healthy adults who are ≥18 years old and ≤59 years old will be enrolled in the adult group and healthy elderly population who are \>59 years old will be enrolled in the elderly group. To ensure the enrollment of healthy subjects, screening tests (hematology, biochemistry, and urinalysis) will be performed prior to the vaccination. In the adults group, there are four regimen cohort: middle-dose at 0, 14 schedule, high-dose at 0, 14 schedule, middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. In the elderly group, there are two regimen cohort: middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1. The study will set up an Independent Data Monitoring Committee (IDMC) to conduct overall supervision. The IDMC is required to review the unblinded data when a significant event or risk occurs in the study that might cause the study to be suspended.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
216
Two doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14.
Three doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.
Two doses of high-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHOCell) at the schedule of day 0, 14.
Three doses of middle-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.
Two doses of placebo (0.5ml) at the schedule of day 0, 14.
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.
Two doses of placebo (0.5ml) at the schedule of day 0, 14.
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
RECRUITINGThe proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.
Time frame: 28 days after first dose
The proportion of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.
Time frame: 7 days after each dose
The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 3 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo
Time frame: 3 days after each dose
The proportion of serious adverse events up to Month 12 after prime and boost vaccination.
Time frame: Month 12 after prime and boost vaccination
The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GMI at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#
Time frame: Day 14, Day 21, Day 28, Day 42 after prime vaccination
The proportion of IgG antibody positive rate at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#
Time frame: Day 14, Day 21, Day 28, Day 42 after prime vaccination
The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GM at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#
Time frame: Day 28, Day 35, Day 42, Day 56 after prime vaccination
The proportion of IgG antibody positive rate at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#
Time frame: Day 28, Day 35, Day 42, Day 56 after prime vaccination
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