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 (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).
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 (Sf9 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 8 research group, including two immunization procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) 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, 960 in total.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
960
18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Geometric mean (GMT) of specific antibody
Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA)
Time frame: 1 months after immunization in each study group
The incidence of adverse reaction (AR)
The incidence of adverse reaction (AR)
Time frame: 0 to 7 days after vaccination in each study group
The incidence of adverse events (AE)
The incidence of adverse events (AE)
Time frame: 0 to 28 days after vaccination in each study group
The incidence of severe adverse events (SAE)
The incidence of severe adverse events (SAE)
Time frame: 0 to 28 days after vaccination in each study group
The incidence of serious adverse events
The incidence of serious adverse events
Time frame: 6 months after vaccination in each study group
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)
Time frame: 1 months after immunization in each study group
The positive conversion rate of S-RBD protein-specific antibody
The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
Time frame: 14 days, 30 days after immunization in each study group
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18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
Geometric mean fold increase (GMI) of S-RBD protein-specific antibody
Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
Time frame: 14 days, 30 days after immunization in each study group
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)
Time frame: 14 days after immunization in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)
Time frame: 14 days, 30 days after immunization in each study group
Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies
Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)
Time frame: 14 days, 30 days after immunization in each study group