An Interventional, Randomized, Parallel Controlled, Investigator Initiated Study to Investigate the Safety, Immunogenicity of Bivalent RQ3027 and RQ3025 mRNA Vaccine as a Booster Dose in 3 Doses COVID-19 Vaccine-Experienced Healthy Adults

YNUVC-2022003

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.

2023-05-08

2023-06-10

2023-11-23

Completed

376

Inclusion Criteria: * Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. * Participants 18 through 55 years of ages. * Participants who have received at least 3 doses COVID-19 vaccine. * Participants with the last prior dose being 90 or more days before Visit 1(Day 0) or recovered from COVID-19 at least 28 days. * Participants able to comply with all scheduled visits, laboratory tests and investigator's instruction. Exclusion Criteria: * Women who are pregnant or breastfeeding. * Enrolling in or planning to participate other interventional clinical study. * Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. * History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. * Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. * Continued using anticoagulants such as coumarin and related anticoagulants (i.e., warfarin) or oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran, and edoxaban). * Having coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors and poorly controlled. * Immunocompromised or having immunosuppressive therapy. * Suspected or confirmed alcohol/drug dependence. * Investigator decide unsuitable factors for participating in clinical trials in the investigator's judgment

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2024-01-24