The goal of this clinical trial is to learn if the SARS-CoV-2 subunit mucosal vaccine with the recombinant flagellin protein adjuvant works to Prevent COVID-19 infection. It will also learn about the Safety and immunogenicity of the vaccine.
This study explored the dosing of the 3R-NC containing BA.2.86 strain, EG.5 strain, and WIV 1 strain receptor binding domain(RBD) with the the recombinant flagellin protein adjuvant KFD1 (KFD1)in healthy subjects, further evaluating the safety, tolerability, and immunogenicity of the recombinant flagellin protein adjuvant KFD1 (KFD1) as a mucosal immune enhancer. KFD1 was divided into four dosage groups (0μg, 20μg, 40μg, 80μg), with each dosage group receiving two administrations. Safety assessments were conducted 7 days after each dosage group, and the next dosage group could only be administered after confirming safety. Samples including saliva, nasal wash, and blood were collected at different time points after the two vaccinations to evaluate safety and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(0µg + 80µg)
SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(20µg + 80µg)
SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(40µg + 80µg)
Shanghai Public Health Clinical Center,Fudan University
Shanghai, Jinshan District, China
Safety Tolerance Evaluation Indicators
Evaluate the adverse reactions of patients after vaccination according to the CTCAE standards, which include local reactions and systemic reactions, graded from level 1 to level 5.
Time frame: Screening period, Day1, Day2, Day22、Day23、Day43±2
IgA and IgG titers in saliva and nasal wash fluid
Using the ELISA method, we detected RBD-specific IgA, IgG, as well as total IgA and IgG titers in saliva and nasal wash samples, and calculated the relative concentrations of RBD-specific IgA and IgG in total IgA and IgG.
Time frame: saliva:Day1、Day22、Day43±2、Day112±5、Day202±5;nasal wash fluid:Day1、Day22、Day43±2、Day112±5、Day202±5
plasma SARS-CoV-2 RBD-specific IgG and IgA titers
Determination of Plasma SARS-CoV-2 RBD-Specific IgG, IgA Titers
Time frame: Screening period, Day1、Day22、Day43±2、Day112±5、Day202±5
plasma neutralizing antibody titers
Using the ELISA method, we detected plasma neutralizing antibody titers
Time frame: Day1、Day22、Day43±2、Day112±5、Day202±5
Titers of flagellin-specific IgG and IgA in plasma
Determination of flagellin-specific IgG and IgA in plasma
Time frame: Day1、Day22、Day43±2、Day112±5、Day202±5
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SARS-CoV-2 subunit mucosal vaccine adjuvanted with flagellin protein(80µg + 80µg)