The Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) developed by WestVac Biopharma Co., Ltd. is a monovalent modified vaccine designed against Omicron XBB.1.5. This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical study with two cohorts, i.e. the immuno-bridging observational cohort and the efficacy observational cohort, aims to evaluate the efficacy, safety, and immunogenicity of booster vaccination with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) for the prevention of SARS-CoV-2 infection in a population of 18 years of age and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,800
boost with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
boost with Recombinant COVID-19 Variant Vaccine (Sf9 Cell)
boost with saline
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
RECRUITINGEfficacy against COVID-19
Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of symptomatic COVID-19, regardless of severity, 14 days to 6 months after booster vaccination.
Time frame: 14 days to 6 months after vaccination
AEs and ARs
Incidence of adverse events (AEs) and adverse reactions (ARs) 0-7 days after booster vaccination.
Time frame: 0-7 days after vaccination
Efficacy against COVID-19
Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of moderate/severe COVID-19 caused by SARS-CoV-2 infection, cases of hospitalization due to COVID-19, and cases of death due to COVID-19, \> 14 days to 6 months after booster vaccination.
Time frame: 14 days to 6 months after booster vaccination
Efficacy against COVID-19
Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of symptomatic COVID-19, regardless of severity, 7 days to 6 months after booster vaccination.
Time frame: 7 days to 6 months after booster vaccination
Efficacy against COVID-19
Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of moderate/severe COVID-19 caused by SARS-CoV-2 infection, cases of hospitalization due to COVID-19, and cases of death due to COVID-19, \> 7 days to 6 months after booster vaccination.
Time frame: 7 days to 6 months after booster vaccination
AEs and ARs
Incidence of adverse events (AEs) and adverse reactions (ARs) 0-30 days after booster vaccination.
Time frame: 0-30 days after booster vaccination
SAEs and AESIs
Incidence of serious adverse events (SAE) and adverse events of special interest (AESI) within 12 months after booster vaccination.
Time frame: within 12 months after booster vaccination
Immunogenicity
The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of neutralizing antibodies (true virus and pseudo-virus assay) against SARS-CoV-2 Omicron XBB.1.5 variant and the main circulating strain at that time on day 14 after booster vaccination.
Time frame: day 14 after booster vaccination
Immunogenicity
The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of neutralizing antibodies (pseudo-virus assay) against SARS-CoV-2 Omicron XBB.1.5 variant and the main circulating strain at that time on day 14, day 30, 3 months and 6 months after booster vaccination.
Time frame: day 14, day 30, 3 months and 6 months after booster vaccination
Immunogenicity
The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of IgG antibodies against SARS-CoV-2 S-RBD protein on day 14, day 30, 3 months and 6 months after booster vaccination.
Time frame: day 14, day 30, 3 months and 6 months after booster vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.