This is a phase Ⅱ, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days).
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 4 research group, including an immunization procedures (0, 28, 56 days), two doses (20μg/0.5ml, 40μg/0.5ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 480 in total. Cellular immune blood samples were collected from the top 96 subjects (i.e., the top 24 in each study group, vaccine group: control group =5:1), and Elispot test and cytokine staining (ICS)/flow assay were performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
480
18-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
18-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
RECRUITINGThe positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays)
Time frame: 30 days after full-course vaccination in each study group
The incidence of adverse reaction (AR)
Time frame: 0 to 7 days after vaccination in each study group
The incidence of adverse events (AE)
Time frame: 0 to 30 days after vaccination in each study group
The incidence of severe adverse events (SAE)
Time frame: 12 months after prime and boost vaccination
The Geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays)
Time frame: 14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group
The Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays)
Time frame: 14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays)
Time frame: 14 days, 6 months and 12 months after full-course vaccination in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (pseudovirus neutralization assays)
Time frame: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
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60-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
60-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
18-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
18-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
60-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
60-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
The positive conversion rate of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Time frame: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
The GMT of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Time frame: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
The GMI of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody
Time frame: 14 days, 30days, 6 months and 12 months after full-course vaccination in each study group