Subjects aged 18 and above who have been completed primary or booster vaccination of COVID-19 inactivated vaccines for 3 months or more, to conduct a randomized, parallel controlled, double-blind, single-center phase I clinical trial of Recombinant variant COVID-19 vaccine (Sf9 cell)(WSK-V102) to evaluate the safety, tolerance and immunogenicity of this vaccine in the study population.
Low and high doses of study vaccine were compared with control groups to evaluate the safety and immunogenicity of the study vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
72
IM
IM
Jiangsu Provincial Center for Disease Control
Taizhou, China
solicited adverse events (AE)
Incidence of solicited adverse events (AE)
Time frame: 0-14 days after vaccination
laboratory safety
Changes in laboratory tests on day 3 after vaccination
Time frame: 3 days after vaccination
safety outcome
Incidence of unsolicited adverse events (AE) and serious adverse events (SAE)
Time frame: 30 days after vaccination,12 months after vaccination
binding antibodies
Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of S-RBD protein-specific antibodies (ELISA) against SARS-CoV-2
Time frame: 14 days, 30 days, 3 months and 6 months
neutralizing antibodies
Geometric mean Titer (GMT) and Geometric mean growth multiple (GMFI) of neutralizing antibodies against SARS-CoV-2 prototype strain and Omicron variant strain (according to the prevailing strain)
Time frame: 14 days, 30 days, 3 months and 6 months
cellular immune
ELISpot was used to detect the cell frequencies of IFN-γ and IL-2 secreted by SARS-CoV-2 S-RBD protein
Time frame: 14 days and 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.