This is a phase Ⅱb, 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 18-59 and 60-85 years) with immunization procedures 0, 21, 42 days and doses 40μg.
This is a phase Ⅱb, 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 18-59 and 60-85 years) . The phase Ⅱb clinical trials designed two research group, including adults group (aged 18-59 years) and elderly adults group (aged 60-85 years). Each group including 2000 participants. Vaccination or placebo group will be randomly assigned to receive in a 3:1 ratio, 4000 in total.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42.
Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42.
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
The incidence of adverse reaction (AR)
The incidence of adverse reaction (AR)
Time frame: 0 to 7 days after each dose
The incidence of Adverse Events of Special Interest (AESI)
The incidence of Adverse Events of Special Interest (AESI)
Time frame: from day 0 to day 60 after last dose
The incidence of adverse events (AE)
The incidence of adverse events (AE)
Time frame: from day 0 to day 30 after last dose
The incidence of grade 3 adverse events (AE)
The incidence of grade 3 adverse events (AE)
Time frame: from day 0 to day 30 after last dose
The incidence of severe adverse events (SAE)
The incidence of severe adverse events (SAE)
Time frame: Month 12 after the whole process of vaccination
Geometric mean (GMT) of specific antibody
Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA) in immunogenicity subgroup.
Time frame: day 30, day 60, month 6, month 12 after last dose
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: day 30, day 60, month 6, month 12 after last dose
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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: day 30, day 60, month 6, month 12 after last dose
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: day 30, day 60, month 6, month 12 after last dose
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: day 30, day 60, month 6, month 12 after last dose
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: day 30, day 60, month 6, month 12 after last dose