This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .
This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with vaccination course 0, 21, 42 days. 892 subjects aged 18-59 years are recruited and randomly inoculated in a 1:1 ratio from a pilot or commercial batch of Recombinant COVID-19 Vaccine (Sf9 Cell).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,000
This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified
Jiangsu Provincial Center for Disease Control and Prevention
Huai'an, Jiangsu, China
The incidence of adverse reactions(ARs).
The incidence of ARs within 7 days after each vaccination.
Time frame: Day 0 to day 7
Anti-SARS-CoV-2 specific neutralizing antibodies expressed as geometric mean titer (GMT)and seroconversion rate (SCR).
The GMT and SCR of anti-SARS-CoV-2 specific neutralizing antibodies (euvirus) of the subjects on day 30 after the third vaccination.
Time frame: Day 72
The incidence of ARs.
The incidence of ARs from Day 0 to Day 72.
Time frame: Day 0 to Day 72
The incidence of adverse events (AEs).
The incidence of adverse events (AEs) from Day 0 to Day 72.
Time frame: Day 0 to Day 72
The incidence of serious adverse events (SAEs).
The incidence of SAEs from day 0 through 6 months after the third vaccination.
Time frame: Day 0 to 6 months after the third vaccination.
The Geometric Mean Fold Increase (GMI) of the anti-SARS-COV-2 specific neutralizing antibody.
The GMI of the anti-SARS-COV-2 specific neutralizing antibody of the subjects on day 30 after the third vaccination.
Time frame: Day 72
The Geometric Mean Titre (GMT), Seroconversion Rate (SCR) and GMI of anti-SARS-COV-2 S-RBD Immunoglobulin (IgG) antibody
The GMT, SCR and GMI of anti-SARS-COV-2 S-RBD IgG antibody of the subjects on day 30 after the third vaccination
Time frame: Day 72
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