A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination to evaluate safety and immunogenicity in healthy population aged 18 years old and above.
To evaluate safety of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) and immunogenicity superiority of WSK-V101C to Recombinant COVID-19 vaccine (WSK-V101) after booster.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,100
boost with Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)
boost with Recombinant COVID-19 vaccine (Sf9 Cell) (WSK-V101)
AE and AR
Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after vaccination.
Time frame: 0-7 days after vaccination
Primary Immunogenicity indicator
The geometric mean titer (GMT) and seroconversion of neutralizing antibodies (true virus or pseudovirus method) against the current variants of SARS-CoV-2 (such as XBB and its subtypes) at day 14 post-vaccination.
Time frame: day 14 post-vaccination
AE and AR
Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days post-vaccination.
Time frame: 0-30 days post-vaccination.
SAE and AE
Incidence of serious adverse events (SAE) and adverse events of specific interest (AESI) within 12 months post-vaccination.
Time frame: within12 months post-vaccination.
Secondary Immunogenicity indicator 1
Geometric mean titer (GMT) and seroconversion rate of neutralizing antibody (true virus or pseudovirus method) against SARS-CoV-2 prototype strain and Omicron BA.2 variant strain on day 14 post-vaccination.
Time frame: day 14 post-vaccination.
Secondary Immunogenicity indicator 2
Geometric mean fold increase (GMI) of neutralizing antibodies against SARS-CoV-2 prototype strains, current variants (such as XBB and its subtypes), and Omicron BA.2 variants (true virus or pseudovirus method) on day 14 post-vaccination.
Time frame: day 14 post-vaccination
Secondary Immunogenicity indicator 3
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Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) against SARS-CoV-2 prototype strains, current variants (such as XBB and its subtypes) and Omicron BA.2 variants neutralizing antibodies (true virus or pseudovirus method) at day 30 post-vaccination.
Time frame: day 30 post-vaccination.
Secondary Immunogenicity indicator 4
Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific binding antibodies at 14 and 30 days after vaccination.
Time frame: 14 and 30 days post-vaccination.