This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are: * The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013 against the current SARS-CoV-2 circulating variant. * The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19 vaccine-experienced participants 18 through 55 years of age. * Explore the protective efficacy by documenting confirmed COVID-19 cases after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
376
0.15mL/dose containing mRNA 30μg
0.15mL/dose containing mRNA 30μg
0.15mL/dose containing mRNA 30μg
The Affiliated Hospital of Yunnan University
Kunming, Yunnan, China
Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
Time frame: Day 14
Number of Participants with Solicited Local and Systemic Averse Events(AEs)
Time frame: Up to Day 14( 7 days after vaccination)
Geometric Mean Titer(GMT) of SARS-Cov-2 Antibodies Against Prototype, Alpha, Beta, BA.5, BF.7, BQ.1.1, XBB.1.5
Time frame: Day 0, Day 7, Day 28, Day 90, Day 180
Number of Participants with Unsolicited Local and Systemic Averse Events(AEs)
Time frame: Up to Day 180( 28 days after vaccination)
Number of Participants with Serious AEs(SAEs)
Time frame: Up to Day 180
The proportion of T cell subsets which secreted by S protein-specific cytokines (IFN-γ, IL-4)
Time frame: Day 7, Day 28, Day 90, Day 180
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