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.
Subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects.
Basic or booster immunization with COVID-19 vaccine ≥6 months.
≥3 months of SARS-CoV-2 infection history, or never infected.
Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols.
Axillary temperature ≥37.3℃.
SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
Anti-SARS-CoV-2 IgM antibody was positive during the screening period.
It is in the advanced stage of malignant tumor and the disease control is unstable.
Parallel
Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)
Biological/Vaccineboost with Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)
Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)
Biological/Vaccineboost 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.
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.
AE and AR
Incidence of adverse events (AE) and adverse reactions (AR) 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.
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.
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.
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This trial is not recruiting at the moment. You can still explore other options:
